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Genetic Engineering: What is Genetic Engineering?

Written by Patrick Dixon

Futurist Keynote Speaker: Posts, Slides, Videos – Biotechnology, Genetics, Gene Therapy, Stem Cells

Genetic engineering is the alteration of genetic code by artificial means, and is therefore different from traditional selective breeding.

Genetic engineering examples include taking the gene that programs poison in the tail of a scorpion, and combining it with a cabbage. These genetically modified cabbages kill caterpillers because they have learned to grow scorpion poison (insecticide) in their sap.

Genetic engineering also includes insertion of human genes into sheep so that they secrete alpha-1 antitrypsin in their milk – a useful substance in treating some cases of lung disease.

Genetic engineering has created a chicken with four legs and no wings.

Genetic engineering has created a goat with spider genes that creates “silk” in its milk.

Genetic engineering works because there is one language of life: human genes work in bacteria, monkey genes work in mice and earthworms. Tree genes work in bananas and frog genes work in rice. There is no limit in theory to the potential of genetic engineering.

Genetic engineering has given us the power to alter the very basis of life on earth.

Genetic engineering has been said to be no different than ancient breeding methods but this is untrue. For a start, breeding or cross-breeding, or in-breeding (for example to make pedigree dogs) all work by using the same species. In contrast genetic engineering allows us to combine fish, mouse, human and insect genes in the same person or animal.

Genetic engineering therefore has few limits – except our imagination, and our moral or ethical code.

Genetic engineering makes the whole digital revolution look nothing. Digital technology changes what we do. Genetic engineering has the power to change who we are.

Human cloning is a type of genetic engineering, but is not the same as true genetic manipulation. In human cloning, the aim is to duplicate the genes of an existing person so that an identical set is inside a human egg. The result is intended to be a cloned twin, perhaps of a dead child. Genetic engineering in its fullest form would result in the child produced having unique genes – as a result of laboratory interference, and therefore the child will not be an identikit twin.

Genetic engineering could create crops that grow in desert heat, or without fertiliser. Genetic engineering could make bananas or other fruit which contain vaccines or other medical products.

Genetic engineering will alter the basis of life on earth – permanently – unless controlled. This could happen if – say – mutant viruses, or bacteria, or fish or reptiles are released into the general environment.

READ FREE BOOK on Genetic Engineering – by Patrick Dixon, author of 16 books and creator of this website – read now: Chapters 1 and 2 explain basics in way which is easy to understand.

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Genetic Engineering: What is Genetic Engineering?

genetic engineering | Definition, Process, & Uses …

Genetic engineering, the artificial manipulation, modification, and recombination of DNA or other nucleic acid molecules in order to modify an organism or population of organisms.

The term genetic engineering initially referred to various techniques used for the modification or manipulation of organisms through the processes of heredity and reproduction. As such, the term embraced both artificial selection and all the interventions of biomedical techniques, among them artificial insemination, in vitro fertilization (e.g., test-tube babies), cloning, and gene manipulation. In the latter part of the 20th century, however, the term came to refer more specifically to methods of recombinant DNA technology (or gene cloning), in which DNA molecules from two or more sources are combined either within cells or in vitro and are then inserted into host organisms in which they are able to propagate.

The possibility for recombinant DNA technology emerged with the discovery of restriction enzymes in 1968 by Swiss microbiologist Werner Arber. The following year American microbiologist Hamilton O. Smith purified so-called type II restriction enzymes, which were found to be essential to genetic engineering for their ability to cleave a specific site within the DNA (as opposed to type I restriction enzymes, which cleave DNA at random sites). Drawing on Smiths work, American molecular biologist Daniel Nathans helped advance the technique of DNA recombination in 197071 and demonstrated that type II enzymes could be useful in genetic studies. Genetic engineering based on recombination was pioneered in 1973 by American biochemists Stanley N. Cohen and Herbert W. Boyer, who were among the first to cut DNA into fragments, rejoin different fragments, and insert the new genes into E. coli bacteria, which then reproduced.

Most recombinant DNA technology involves the insertion of foreign genes into the plasmids of common laboratory strains of bacteria. Plasmids are small rings of DNA; they are not part of the bacteriums chromosome (the main repository of the organisms genetic information). Nonetheless, they are capable of directing protein synthesis, and, like chromosomal DNA, they are reproduced and passed on to the bacteriums progeny. Thus, by incorporating foreign DNA (for example, a mammalian gene) into a bacterium, researchers can obtain an almost limitless number of copies of the inserted gene. Furthermore, if the inserted gene is operative (i.e., if it directs protein synthesis), the modified bacterium will produce the protein specified by the foreign DNA.

A subsequent generation of genetic engineering techniques that emerged in the early 21st century centred on gene editing. Gene editing, based on a technology known as CRISPR-Cas9, allows researchers to customize a living organisms genetic sequence by making very specific changes to its DNA. Gene editing has a wide array of applications, being used for the genetic modification of crop plants and livestock and of laboratory model organisms (e.g., mice). The correction of genetic errors associated with disease in animals suggests that gene editing has potential applications in gene therapy for humans.

Genetic engineering has advanced the understanding of many theoretical and practical aspects of gene function and organization. Through recombinant DNA techniques, bacteria have been created that are capable of synthesizing human insulin, human growth hormone, alpha interferon, a hepatitis B vaccine, and other medically useful substances. Plants may be genetically adjusted to enable them to fix nitrogen, and genetic diseases can possibly be corrected by replacing dysfunctional genes with normally functioning genes. Nevertheless, special concern has been focused on such achievements for fear that they might result in the introduction of unfavourable and possibly dangerous traits into microorganisms that were previously free of theme.g., resistance to antibiotics, production of toxins, or a tendency to cause disease. Likewise, the application of gene editing in humans has raised ethical concerns, particularly regarding its potential use to alter traits such as intelligence and beauty.

In 1980 the new microorganisms created by recombinant DNA research were deemed patentable, and in 1986 the U.S. Department of Agriculture approved the sale of the first living genetically altered organisma virus, used as a pseudorabies vaccine, from which a single gene had been cut. Since then several hundred patents have been awarded for genetically altered bacteria and plants. Patents on genetically engineered and genetically modified organisms, particularly crops and other foods, however, were a contentious issue, and they remained so into the first part of the 21st century.

The culmination of such advances in techniques for influencing human reproduction will be the mastery of genetic engineering. Already in the late 20th century, some couples in the United States paid substantial sums for eggs from women with outstanding test scores at elite colleges. (Payment for eggs or sperm was illegal in most other countries.) Prenatal testing for genetic defects was also…

The application of genetics to agriculture since World War II has resulted in substantial increases in the production of many crops. This has been most notable in hybrid strains of maize and grain sorghum. At the same time, crossbreeding has resulted in much more productive strains of wheat and rice. Called artificial selection or selective breeding, these techniques have become aspects of a…

…for the manipulation of atoms and molecules and of cells and their genetic structures. Chemists perform molecular tailoring today as a matter of course, cutting and shaping molecules at will. Genetic engineering makes possible active human intervention in the evolutionary process and holds out the possibility of tailoring living organisms, including the human organism, to specific tasks….

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genetic engineering | Definition, Process, & Uses …

Gene therapy – Wikipedia

Gene therapy is the therapeutic delivery of nucleic acid polymers into a patient’s cells as a drug to treat disease.[1] The first attempt at modifying human DNA was performed in 1980 by Martin Cline, but the first successful nuclear gene transfer in humans, approved by the National Institutes of Health, was performed in May 1989.[2] The first therapeutic use of gene transfer as well as the first direct insertion of human DNA into the nuclear genome was performed by French Anderson in a trial starting in September 1990.

Between 1989 and February 2016, over 2,300 clinical trials had been conducted, more than half of them in phase I.[3]

Not all medical procedures that introduce alterations to a patient’s genetic makeup can be considered gene therapy. Bone marrow transplantation and organ transplants in general have been found to introduce foreign DNA into patients.[4] Gene therapy is defined by the precision of the procedure and the intention of direct therapeutic effects.

Gene therapy was conceptualized in 1972, by authors who urged caution before commencing human gene therapy studies.

The first attempt, an unsuccessful one, at gene therapy (as well as the first case of medical transfer of foreign genes into humans not counting organ transplantation) was performed by Martin Cline on 10 July 1980.[5][6] Cline claimed that one of the genes in his patients was active six months later, though he never published this data or had it verified[7] and even if he is correct, it’s unlikely it produced any significant beneficial effects treating beta-thalassemia.

After extensive research on animals throughout the 1980s and a 1989 bacterial gene tagging trial on humans, the first gene therapy widely accepted as a success was demonstrated in a trial that started on 14 September 1990, when Ashi DeSilva was treated for ADA-SCID.[8]

The first somatic treatment that produced a permanent genetic change was performed in 1993.[9]

This procedure was referred to sensationally and somewhat inaccurately in the media as a “three parent baby”, though mtDNA is not the primary human genome and has little effect on an organism’s individual characteristics beyond powering their cells.

Gene therapy is a way to fix a genetic problem at its source. The polymers are either translated into proteins, interfere with target gene expression, or possibly correct genetic mutations.

The most common form uses DNA that encodes a functional, therapeutic gene to replace a mutated gene. The polymer molecule is packaged within a “vector”, which carries the molecule inside cells.

Early clinical failures led to dismissals of gene therapy. Clinical successes since 2006 regained researchers’ attention, although as of 2014, it was still largely an experimental technique.[10] These include treatment of retinal diseases Leber’s congenital amaurosis[11][12][13][14] and choroideremia,[15]X-linked SCID,[16] ADA-SCID,[17][18]adrenoleukodystrophy,[19]chronic lymphocytic leukemia (CLL),[20]acute lymphocytic leukemia (ALL),[21]multiple myeloma,[22]haemophilia[18] and Parkinson’s disease.[23] Between 2013 and April 2014, US companies invested over $600 million in the field.[24]

The first commercial gene therapy, Gendicine, was approved in China in 2003 for the treatment of certain cancers.[25] In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia.[26] In 2012 Glybera, a treatment for a rare inherited disorder, became the first treatment to be approved for clinical use in either Europe or the United States after its endorsement by the European Commission.[10][27]

Following early advances in genetic engineering of bacteria, cells, and small animals, scientists started considering how to apply it to medicine. Two main approaches were considered replacing or disrupting defective genes.[28] Scientists focused on diseases caused by single-gene defects, such as cystic fibrosis, haemophilia, muscular dystrophy, thalassemia and sickle cell anemia. Glybera treats one such disease, caused by a defect in lipoprotein lipase.[27]

DNA must be administered, reach the damaged cells, enter the cell and either express or disrupt a protein.[29] Multiple delivery techniques have been explored. The initial approach incorporated DNA into an engineered virus to deliver the DNA into a chromosome.[30][31]Naked DNA approaches have also been explored, especially in the context of vaccine development.[32]

Generally, efforts focused on administering a gene that causes a needed protein to be expressed. More recently, increased understanding of nuclease function has led to more direct DNA editing, using techniques such as zinc finger nucleases and CRISPR. The vector incorporates genes into chromosomes. The expressed nucleases then knock out and replace genes in the chromosome. As of 2014 these approaches involve removing cells from patients, editing a chromosome and returning the transformed cells to patients.[33]

Gene editing is a potential approach to alter the human genome to treat genetic diseases,[34] viral diseases,[35] and cancer.[36] As of 2016 these approaches were still years from being medicine.[37][38]

Gene therapy may be classified into two types:

In somatic cell gene therapy (SCGT), the therapeutic genes are transferred into any cell other than a gamete, germ cell, gametocyte or undifferentiated stem cell. Any such modifications affect the individual patient only, and are not inherited by offspring. Somatic gene therapy represents mainstream basic and clinical research, in which therapeutic DNA (either integrated in the genome or as an external episome or plasmid) is used to treat disease.

Over 600 clinical trials utilizing SCGT are underway in the US. Most focus on severe genetic disorders, including immunodeficiencies, haemophilia, thalassaemia and cystic fibrosis. Such single gene disorders are good candidates for somatic cell therapy. The complete correction of a genetic disorder or the replacement of multiple genes is not yet possible. Only a few of the trials are in the advanced stages.[39]

In germline gene therapy (GGT), germ cells (sperm or eggs) are modified by the introduction of functional genes into their genomes. Modifying a germ cell causes all the organism’s cells to contain the modified gene. The change is therefore heritable and passed on to later generations. Australia, Canada, Germany, Israel, Switzerland and the Netherlands[40] prohibit GGT for application in human beings, for technical and ethical reasons, including insufficient knowledge about possible risks to future generations[40] and higher risks versus SCGT.[41] The US has no federal controls specifically addressing human genetic modification (beyond FDA regulations for therapies in general).[40][42][43][44]

The delivery of DNA into cells can be accomplished by multiple methods. The two major classes are recombinant viruses (sometimes called biological nanoparticles or viral vectors) and naked DNA or DNA complexes (non-viral methods).

In order to replicate, viruses introduce their genetic material into the host cell, tricking the host’s cellular machinery into using it as blueprints for viral proteins. Retroviruses go a stage further by having their genetic material copied into the genome of the host cell. Scientists exploit this by substituting a virus’s genetic material with therapeutic DNA. (The term ‘DNA’ may be an oversimplification, as some viruses contain RNA, and gene therapy could take this form as well.) A number of viruses have been used for human gene therapy, including retroviruses, adenoviruses, herpes simplex, vaccinia and adeno-associated virus.[3] Like the genetic material (DNA or RNA) in viruses, therapeutic DNA can be designed to simply serve as a temporary blueprint that is degraded naturally or (at least theoretically) to enter the host’s genome, becoming a permanent part of the host’s DNA in infected cells.

Non-viral methods present certain advantages over viral methods, such as large scale production and low host immunogenicity. However, non-viral methods initially produced lower levels of transfection and gene expression, and thus lower therapeutic efficacy. Later technology remedied this deficiency[citation needed].

Methods for non-viral gene therapy include the injection of naked DNA, electroporation, the gene gun, sonoporation, magnetofection, the use of oligonucleotides, lipoplexes, dendrimers, and inorganic nanoparticles.

Some of the unsolved problems include:

Three patients’ deaths have been reported in gene therapy trials, putting the field under close scrutiny. The first was that of Jesse Gelsinger in 1999. Jesse Gelsinger was dead because of immune rejection response.[51] One X-SCID patient died of leukemia in 2003.[8] In 2007, a rheumatoid arthritis patient died from an infection; the subsequent investigation concluded that the death was not related to gene therapy.[52]

In 1972 Friedmann and Roblin authored a paper in Science titled “Gene therapy for human genetic disease?”[53] Rogers (1970) was cited for proposing that exogenous good DNA be used to replace the defective DNA in those who suffer from genetic defects.[54]

In 1984 a retrovirus vector system was designed that could efficiently insert foreign genes into mammalian chromosomes.[55]

The first approved gene therapy clinical research in the US took place on 14 September 1990, at the National Institutes of Health (NIH), under the direction of William French Anderson.[56] Four-year-old Ashanti DeSilva received treatment for a genetic defect that left her with ADA-SCID, a severe immune system deficiency. The effects were temporary, but successful.[57]

Cancer gene therapy was introduced in 1992/93 (Trojan et al. 1993).[58] The treatment of glioblastoma multiforme, the malignant brain tumor whose outcome is always fatal, was done using a vector expressing antisense IGF-I RNA (clinical trial approved by NIH protocolno.1602 November 24, 1993,[59] and by the FDA in 1994). This therapy also represents the beginning of cancer immunogene therapy, a treatment which proves to be effective due to the anti-tumor mechanism of IGF-I antisense, which is related to strong immune and apoptotic phenomena.

In 1992 Claudio Bordignon, working at the Vita-Salute San Raffaele University, performed the first gene therapy procedure using hematopoietic stem cells as vectors to deliver genes intended to correct hereditary diseases.[60] In 2002 this work led to the publication of the first successful gene therapy treatment for adenosine deaminase deficiency (ADA-SCID). The success of a multi-center trial for treating children with SCID (severe combined immune deficiency or “bubble boy” disease) from 2000 and 2002, was questioned when two of the ten children treated at the trial’s Paris center developed a leukemia-like condition. Clinical trials were halted temporarily in 2002, but resumed after regulatory review of the protocol in the US, the United Kingdom, France, Italy and Germany.[61]

In 1993 Andrew Gobea was born with SCID following prenatal genetic screening. Blood was removed from his mother’s placenta and umbilical cord immediately after birth, to acquire stem cells. The allele that codes for adenosine deaminase (ADA) was obtained and inserted into a retrovirus. Retroviruses and stem cells were mixed, after which the viruses inserted the gene into the stem cell chromosomes. Stem cells containing the working ADA gene were injected into Andrew’s blood. Injections of the ADA enzyme were also given weekly. For four years T cells (white blood cells), produced by stem cells, made ADA enzymes using the ADA gene. After four years more treatment was needed.[citation needed]

Jesse Gelsinger’s death in 1999 impeded gene therapy research in the US.[62][63] As a result, the FDA suspended several clinical trials pending the reevaluation of ethical and procedural practices.[64]

The modified cancer gene therapy strategy of antisense IGF-I RNA (NIH n 1602)[59] using antisense / triple helix anti IGF-I approach was registered in 2002 by Wiley gene therapy clinical trial – n 635 and 636. The approach has shown promising results in the treatment of six different malignant tumors: glioblastoma, cancers of liver, colon, prostate, uterus and ovary (Collaborative NATO Science Programme on Gene Therapy USA, France, Poland n LST 980517 conducted by J. Trojan) (Trojan et al., 2012). This antigene antisense/triple helix therapy has proven to be efficient, due to the mechanism stopping simultaneously IGF-I expression on translation and transcription levels, strengthening anti-tumor immune and apoptotic phenomena.

Sickle-cell disease can be treated in mice.[65] The mice which have essentially the same defect that causes human cases used a viral vector to induce production of fetal hemoglobin (HbF), which normally ceases to be produced shortly after birth. In humans, the use of hydroxyurea to stimulate the production of HbF temporarily alleviates sickle cell symptoms. The researchers demonstrated this treatment to be a more permanent means to increase therapeutic HbF production.[66]

A new gene therapy approach repaired errors in messenger RNA derived from defective genes. This technique has the potential to treat thalassaemia, cystic fibrosis and some cancers.[67]

Researchers created liposomes 25 nanometers across that can carry therapeutic DNA through pores in the nuclear membrane.[68]

In 2003 a research team inserted genes into the brain for the first time. They used liposomes coated in a polymer called polyethylene glycol, which, unlike viral vectors, are small enough to cross the bloodbrain barrier.[69]

Short pieces of double-stranded RNA (short, interfering RNAs or siRNAs) are used by cells to degrade RNA of a particular sequence. If a siRNA is designed to match the RNA copied from a faulty gene, then the abnormal protein product of that gene will not be produced.[70]

Gendicine is a cancer gene therapy that delivers the tumor suppressor gene p53 using an engineered adenovirus. In 2003, it was approved in China for the treatment of head and neck squamous cell carcinoma.[25]

In March researchers announced the successful use of gene therapy to treat two adult patients for X-linked chronic granulomatous disease, a disease which affects myeloid cells and damages the immune system. The study is the first to show that gene therapy can treat the myeloid system.[71]

In May a team reported a way to prevent the immune system from rejecting a newly delivered gene.[72] Similar to organ transplantation, gene therapy has been plagued by this problem. The immune system normally recognizes the new gene as foreign and rejects the cells carrying it. The research utilized a newly uncovered network of genes regulated by molecules known as microRNAs. This natural function selectively obscured their therapeutic gene in immune system cells and protected it from discovery. Mice infected with the gene containing an immune-cell microRNA target sequence did not reject the gene.

In August scientists successfully treated metastatic melanoma in two patients using killer T cells genetically retargeted to attack the cancer cells.[73]

In November researchers reported on the use of VRX496, a gene-based immunotherapy for the treatment of HIV that uses a lentiviral vector to deliver an antisense gene against the HIV envelope. In a phase I clinical trial, five subjects with chronic HIV infection who had failed to respond to at least two antiretroviral regimens were treated. A single intravenous infusion of autologous CD4 T cells genetically modified with VRX496 was well tolerated. All patients had stable or decreased viral load; four of the five patients had stable or increased CD4 T cell counts. All five patients had stable or increased immune response to HIV antigens and other pathogens. This was the first evaluation of a lentiviral vector administered in a US human clinical trial.[74][75]

In May researchers announced the first gene therapy trial for inherited retinal disease. The first operation was carried out on a 23-year-old British male, Robert Johnson, in early 2007.[76]

Leber’s congenital amaurosis is an inherited blinding disease caused by mutations in the RPE65 gene. The results of a small clinical trial in children were published in April.[11] Delivery of recombinant adeno-associated virus (AAV) carrying RPE65 yielded positive results. In May two more groups reported positive results in independent clinical trials using gene therapy to treat the condition. In all three clinical trials, patients recovered functional vision without apparent side-effects.[11][12][13][14]

In September researchers were able to give trichromatic vision to squirrel monkeys.[77] In November 2009, researchers halted a fatal genetic disorder called adrenoleukodystrophy in two children using a lentivirus vector to deliver a functioning version of ABCD1, the gene that is mutated in the disorder.[78]

An April paper reported that gene therapy addressed achromatopsia (color blindness) in dogs by targeting cone photoreceptors. Cone function and day vision were restored for at least 33 months in two young specimens. The therapy was less efficient for older dogs.[79]

In September it was announced that an 18-year-old male patient in France with beta-thalassemia major had been successfully treated.[80] Beta-thalassemia major is an inherited blood disease in which beta haemoglobin is missing and patients are dependent on regular lifelong blood transfusions.[81] The technique used a lentiviral vector to transduce the human -globin gene into purified blood and marrow cells obtained from the patient in June 2007.[82] The patient’s haemoglobin levels were stable at 9 to 10 g/dL. About a third of the hemoglobin contained the form introduced by the viral vector and blood transfusions were not needed.[82][83] Further clinical trials were planned.[84]Bone marrow transplants are the only cure for thalassemia, but 75% of patients do not find a matching donor.[83]

Cancer immunogene therapy using modified anti gene, antisense / triple helix approach was introduced in South America in 2010/11 in La Sabana University, Bogota (Ethical Committee 14 December 2010, no P-004-10). Considering the ethical aspect of gene diagnostic and gene therapy targeting IGF-I, the IGF-I expressing tumors i.e. lung and epidermis cancers, were treated (Trojan et al. 2016).[85][86]

In 2007 and 2008, a man (Timothy Ray Brown) was cured of HIV by repeated hematopoietic stem cell transplantation (see also allogeneic stem cell transplantation, allogeneic bone marrow transplantation, allotransplantation) with double-delta-32 mutation which disables the CCR5 receptor. This cure was accepted by the medical community in 2011.[87] It required complete ablation of existing bone marrow, which is very debilitating.

In August two of three subjects of a pilot study were confirmed to have been cured from chronic lymphocytic leukemia (CLL). The therapy used genetically modified T cells to attack cells that expressed the CD19 protein to fight the disease.[20] In 2013, the researchers announced that 26 of 59 patients had achieved complete remission and the original patient had remained tumor-free.[88]

Human HGF plasmid DNA therapy of cardiomyocytes is being examined as a potential treatment for coronary artery disease as well as treatment for the damage that occurs to the heart after myocardial infarction.[89][90]

In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia; it delivers the gene encoding for VEGF.[91][26] Neovasculogen is a plasmid encoding the CMV promoter and the 165 amino acid form of VEGF.[92][93]

The FDA approved Phase 1 clinical trials on thalassemia major patients in the US for 10 participants in July.[94] The study was expected to continue until 2015.[95]

In July 2012, the European Medicines Agency recommended approval of a gene therapy treatment for the first time in either Europe or the United States. The treatment used Alipogene tiparvovec (Glybera) to compensate for lipoprotein lipase deficiency, which can cause severe pancreatitis.[96] The recommendation was endorsed by the European Commission in November 2012[10][27][97][98] and commercial rollout began in late 2014.[99] Alipogene tiparvovec was expected to cost around $1.6 million per treatment in 2012,[100] revised to $1 million in 2015,[101] making it the most expensive medicine in the world at the time.[102] As of 2016, only one person had been treated with drug.[103]

In December 2012, it was reported that 10 of 13 patients with multiple myeloma were in remission “or very close to it” three months after being injected with a treatment involving genetically engineered T cells to target proteins NY-ESO-1 and LAGE-1, which exist only on cancerous myeloma cells.[22]

In March researchers reported that three of five adult subjects who had acute lymphocytic leukemia (ALL) had been in remission for five months to two years after being treated with genetically modified T cells which attacked cells with CD19 genes on their surface, i.e. all B-cells, cancerous or not. The researchers believed that the patients’ immune systems would make normal T-cells and B-cells after a couple of months. They were also given bone marrow. One patient relapsed and died and one died of a blood clot unrelated to the disease.[21]

Following encouraging Phase 1 trials, in April, researchers announced they were starting Phase 2 clinical trials (called CUPID2 and SERCA-LVAD) on 250 patients[104] at several hospitals to combat heart disease. The therapy was designed to increase the levels of SERCA2, a protein in heart muscles, improving muscle function.[105] The FDA granted this a Breakthrough Therapy Designation to accelerate the trial and approval process.[106] In 2016 it was reported that no improvement was found from the CUPID 2 trial.[107]

In July researchers reported promising results for six children with two severe hereditary diseases had been treated with a partially deactivated lentivirus to replace a faulty gene and after 732 months. Three of the children had metachromatic leukodystrophy, which causes children to lose cognitive and motor skills.[108] The other children had Wiskott-Aldrich syndrome, which leaves them to open to infection, autoimmune diseases and cancer.[109] Follow up trials with gene therapy on another six children with Wiskott-Aldrich syndrome were also reported as promising.[110][111]

In October researchers reported that two children born with adenosine deaminase severe combined immunodeficiency disease (ADA-SCID) had been treated with genetically engineered stem cells 18 months previously and that their immune systems were showing signs of full recovery. Another three children were making progress.[18] In 2014 a further 18 children with ADA-SCID were cured by gene therapy.[112] ADA-SCID children have no functioning immune system and are sometimes known as “bubble children.”[18]

Also in October researchers reported that they had treated six haemophilia sufferers in early 2011 using an adeno-associated virus. Over two years later all six were producing clotting factor.[18][113]

In January researchers reported that six choroideremia patients had been treated with adeno-associated virus with a copy of REP1. Over a six-month to two-year period all had improved their sight.[114][115] By 2016, 32 patients had been treated with positive results and researchers were hopeful the treatment would be long-lasting.[15] Choroideremia is an inherited genetic eye disease with no approved treatment, leading to loss of sight.

In March researchers reported that 12 HIV patients had been treated since 2009 in a trial with a genetically engineered virus with a rare mutation (CCR5 deficiency) known to protect against HIV with promising results.[116][117]

Clinical trials of gene therapy for sickle cell disease were started in 2014.[118][119] There is a need for high quality randomised controlled trials assessing the risks and benefits involved with gene therapy for people with sickle cell disease.[120]

In February LentiGlobin BB305, a gene therapy treatment undergoing clinical trials for treatment of beta thalassemia gained FDA “breakthrough” status after several patients were able to forgo the frequent blood transfusions usually required to treat the disease.[121]

In March researchers delivered a recombinant gene encoding a broadly neutralizing antibody into monkeys infected with simian HIV; the monkeys’ cells produced the antibody, which cleared them of HIV. The technique is named immunoprophylaxis by gene transfer (IGT). Animal tests for antibodies to ebola, malaria, influenza and hepatitis were underway.[122][123]

In March, scientists, including an inventor of CRISPR, urged a worldwide moratorium on germline gene therapy, writing scientists should avoid even attempting, in lax jurisdictions, germline genome modification for clinical application in humans until the full implications are discussed among scientific and governmental organizations.[124][125][126][127]

In October, researchers announced that they had treated a baby girl, Layla Richards, with an experimental treatment using donor T-cells genetically engineered using TALEN to attack cancer cells. One year after the treatment she was still free of her cancer (a highly aggressive form of acute lymphoblastic leukaemia [ALL]).[128] Children with highly aggressive ALL normally have a very poor prognosis and Layla’s disease had been regarded as terminal before the treatment.[129]

In December, scientists of major world academies called for a moratorium on inheritable human genome edits, including those related to CRISPR-Cas9 technologies[130] but that basic research including embryo gene editing should continue.[131]

In April the Committee for Medicinal Products for Human Use of the European Medicines Agency endorsed a gene therapy treatment called Strimvelis[132][133] and the European Commission approved it in June.[134] This treats children born with ADA-SCID and who have no functioning immune system – sometimes called the “bubble baby” disease. This was the second gene therapy treatment to be approved in Europe.[135]

In October, Chinese scientists reported they had started a trial to genetically modify T-cells from 10 adult patients with lung cancer and reinject the modified T-cells back into their bodies to attack the cancer cells. The T-cells had the PD-1 protein (which stops or slows the immune response) removed using CRISPR-Cas9.[136][137]

A 2016 Cochrane systematic review looking at data from four trials on topical cystic fibrosis transmembrane conductance regulator (CFTR) gene therapy does not support its clinical use as a mist inhaled into the lungs to treat cystic fibrosis patients with lung infections. One of the four trials did find weak evidence that liposome-based CFTR gene transfer therapy may lead to a small respiratory improvement for people with CF. This weak evidence is not enough to make a clinical recommendation for routine CFTR gene therapy.[138]

In February Kite Pharma announced results from a clinical trial of CAR-T cells in around a hundred people with advanced Non-Hodgkin lymphoma.[139]

In March, French scientists reported on clinical research of gene therapy to treat sickle-cell disease.[140]

Speculated uses for gene therapy include:

Gene Therapy techniques have the potential to provide alternative treatments for those with infertility. Recently, successful experimentation on mice has proven that fertility can be restored by using the gene therapy method, CRISPR.[141] Spermatogenical stem cells from another organism were transplanted into the testes of an infertile male mouse. The stem cells re-established spermatogenesis and fertility.[142]

Athletes might adopt gene therapy technologies to improve their performance.[143]Gene doping is not known to occur, but multiple gene therapies may have such effects. Kayser et al. argue that gene doping could level the playing field if all athletes receive equal access. Critics claim that any therapeutic intervention for non-therapeutic/enhancement purposes compromises the ethical foundations of medicine and sports.[144]

Genetic engineering could be used to change physical appearance, metabolism, and even improve physical capabilities and mental faculties such as memory and intelligence. Ethical claims about germline engineering include beliefs that every fetus has a right to remain genetically unmodified, that parents hold the right to genetically modify their offspring, and that every child has the right to be born free of preventable diseases.[145][146][147] For parents, genetic engineering could be seen as another child enhancement technique to add to diet, exercise, education, training, cosmetics and plastic surgery.[148][149] Another theorist claims that moral concerns limit but do not prohibit germline engineering.[150]

Possible regulatory schemes include a complete ban, provision to everyone, or professional self-regulation. The American Medical Associations Council on Ethical and Judicial Affairs stated that “genetic interventions to enhance traits should be considered permissible only in severely restricted situations: (1) clear and meaningful benefits to the fetus or child; (2) no trade-off with other characteristics or traits; and (3) equal access to the genetic technology, irrespective of income or other socioeconomic characteristics.”[151]

As early in the history of biotechnology as 1990, there have been scientists opposed to attempts to modify the human germline using these new tools,[152] and such concerns have continued as technology progressed.[153][154] With the advent of new techniques like CRISPR, in March 2015 a group of scientists urged a worldwide moratorium on clinical use of gene editing technologies to edit the human genome in a way that can be inherited.[124][125][126][127] In April 2015, researchers sparked controversy when they reported results of basic research to edit the DNA of non-viable human embryos using CRISPR.[141][155] A committee of the American National Academy of Sciences and National Academy of Medicine gave qualified support to human genome editing in 2017[156][157] once answers have been found to safety and efficiency problems “but only for serious conditions under stringent oversight.”[158]

Regulations covering genetic modification are part of general guidelines about human-involved biomedical research.

The Helsinki Declaration (Ethical Principles for Medical Research Involving Human Subjects) was amended by the World Medical Association’s General Assembly in 2008. This document provides principles physicians and researchers must consider when involving humans as research subjects. The Statement on Gene Therapy Research initiated by the Human Genome Organization (HUGO) in 2001 provides a legal baseline for all countries. HUGOs document emphasizes human freedom and adherence to human rights, and offers recommendations for somatic gene therapy, including the importance of recognizing public concerns about such research.[159]

No federal legislation lays out protocols or restrictions about human genetic engineering. This subject is governed by overlapping regulations from local and federal agencies, including the Department of Health and Human Services, the FDA and NIH’s Recombinant DNA Advisory Committee. Researchers seeking federal funds for an investigational new drug application, (commonly the case for somatic human genetic engineering), must obey international and federal guidelines for the protection of human subjects.[160]

NIH serves as the main gene therapy regulator for federally funded research. Privately funded research is advised to follow these regulations. NIH provides funding for research that develops or enhances genetic engineering techniques and to evaluate the ethics and quality in current research. The NIH maintains a mandatory registry of human genetic engineering research protocols that includes all federally funded projects.

An NIH advisory committee published a set of guidelines on gene manipulation.[161] The guidelines discuss lab safety as well as human test subjects and various experimental types that involve genetic changes. Several sections specifically pertain to human genetic engineering, including Section III-C-1. This section describes required review processes and other aspects when seeking approval to begin clinical research involving genetic transfer into a human patient.[162] The protocol for a gene therapy clinical trial must be approved by the NIH’s Recombinant DNA Advisory Committee prior to any clinical trial beginning; this is different from any other kind of clinical trial.[161]

As with other kinds of drugs, the FDA regulates the quality and safety of gene therapy products and supervises how these products are used clinically. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed and approved by the FDA and an Institutional Review Board.[163][164]

Gene therapy is the basis for the plotline of the film I Am Legend[165] and the TV show Will Gene Therapy Change the Human Race?.[166] It is also used in Stargate as a means of allowing humans to use Ancient technology.[167]

See the article here:

Gene therapy – Wikipedia

Genetic engineering – Biology-Online Dictionary

Home Genetic engineering

Definition

noun

The technology entailing all processes of altering the genetic material of a cell to make it capable of performing the desired functions, such as producing novel substances.

Supplement

Genetic engineering covers all various experimental techniques that manipulate the genes of the organism. It uses recombinant DNA, molecular cloning and transformation. At present, it is applied in improving crop technology, manufacturing synthetic human insulin (using modified bacteria), production of erythropoietin (using Chinese hamster ovary cells), and production of new types of experimental mice for research (such as cancer mouse). It also has the potential of being used in humans by changing their appearance, intelligence, character and adaptability; however, there are ethical concerns and controversies it has to resolve before it can be widely accepted.

Related forms: genetic engineer (noun). Synonym: recombinant DNA technology, genetic modification, genetic manipulation (GM), gene splicing. See also: bioethics, biotechnology, cloning, genetic pollution.

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Genetic engineering – Biology-Online Dictionary

Genetic Engineering Advantages & Disadvantages – Biology …

During the latter stage stages of the 20th century, man harnessed the power of the atom, and not long after, soon realised the power of genes. Genetic engineering is going to become a very mainstream part of our lives sooner or later, because there are so many possibilities advantages (and disadvantages) involved. Here are just some of the advantages :

Of course there are two sides to the coin, here are some possible eventualities and disadvantages.

Genetic engineering may be one of the greatest breakthroughs in recent history alongside the discovery of the atom and space flight, however, with the above eventualities and facts above in hand, governments have produced legislation to control what sort of experiments are done involving genetic engineering. In the UK there are strict laws prohibiting any experiments involving the cloning of humans. However, over the years here are some of the experimental ‘breakthroughs’ made possible by genetic engineering.

Genetic engineering has been impossible until recent times due to the complex and microscopic nature of DNA and its component nucleotides. Through progressive studies, more and more in this area is being made possible, with the above examples only showing some of the potential that genetic engineering shows.

For us to understand chromosomes and DNA more clearly, they can be mapped for future reference. More simplistic organisms such as fruit fly (Drosophila) have been chromosome mapped due to their simplistic nature meaning they will require less genes to operate. At present, a task named the Human Genome Project is mapping the human genome, and should be completed in the next ten years.

The process of genetic engineering involves splicing an area of a chromosome, a gene, that controls a certain characteristic of the body. The enzyme endonuclease is used to split a DNA sequence and split the gene from the rest of the chromosome. For example, this gene may be programmed to produce an antiviral protein. This gene is removed and can be placed into another organism. For example, it can be placed into a bacteria, where it is sealed into the DNA chain using ligase. When the chromosome is once again sealed, the bacteria is now effectively re-programmed to replicate this new antiviral protein. The bacteria can continue to live a healthy life, though genetic engineering and human intervention has actively manipulated what the bacteria actually is. No doubt there are advantages and disadvantages, and this whole subject area will become more prominent over time.

The next page returns the more natural circumstances of genetic diversity.

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Genetic Engineering Advantages & Disadvantages – Biology …

History of genetic engineering – Wikipedia

Genetic modification caused by human activity has been occurring since around 12,000 BC, when humans first began to domesticate organisms. Genetic engineering as the direct transfer of DNA from one organism to another was first accomplished by Herbert Boyer and Stanley Cohen in 1972. The first genetically modified animal was a mouse created in 1974 by Rudolf Jaenisch. In 1983 an antibiotic resistant gene was inserted into tobacco, leading to the first genetically engineered plant. Advances followed that allowed scientists to manipulate and add genes to a variety of different organism and induce a range of different effects.

In 1976 the technology was commercialized, with the advent of genetically modified bacteria that produced somatostatin, followed by insulin in 1978. Plants were first commercialized with virus resistant tobacco released in China in 1992. The first genetically modified food was the Flavr Savr tomato marketed in 1994. By 2010, 29 countries had planted commercialized biotech crops. In 2000 a paper published in Science introduced golden rice, the first food developed with increased nutrient value.

Genetic engineering is the direct manipulation of an organism’s genome using certain biotechnology techniques that have only existed since the 1970s.[2] Human directed genetic manipulation was occurring much earlier, beginning with the domestication of plants and animals through artificial selection. The dog is believed to be the first animal domesticated, possibly arising from a common ancestor of the grey wolf,[1] with archeological evidence dating to about 12,000 BC.[3] Other carnivores domesticated in prehistoric times include the cat, which cohabited with human 9,500 years ago.[4] Archeological evidence suggests sheep, cattle, pigs and goats were domesticated between 9 000 BC and 8 000 BC in the Fertile Crescent.[5]

The first evidence of plant domestication comes from emmer and einkorn wheat found in pre-Pottery Neolithic A villages in Southwest Asia dated about 10,500 to 10,100 BC. The Fertile Crescent of Western Asia, Egypt, and India were sites of the earliest planned sowing and harvesting of plants that had previously been gathered in the wild. Independent development of agriculture occurred in northern and southern China, Africa’s Sahel, New Guinea and several regions of the Americas.[7] The eight Neolithic founder crops (emmer wheat, einkorn wheat, barley, peas, lentils, bitter vetch, chick peas and flax) had all appeared by about 7000 BC.[8]Horticulture first appears in the Levant during the Chalcolithic period about 6 800 to 6,300 BC. Due to the soft tissues, archeological evidence for early vegetables is scarce. The earliest vegetable remains have been found in Egyptian caves that date back to the 2nd millennium BC.

Selective breeding of domesticated plants was once the main way early farmers shaped organisms to suit their needs. Charles Darwin described three types of selection: methodical selection, wherein humans deliberately select for particular characteristics; unconscious selection, wherein a characteristic is selected simply because it is desirable; and natural selection, wherein a trait that helps an organism survive better is passed on.[11]:25 Early breeding relied on unconscious and natural selection. The introduction of methodical selection is unknown.[11]:25 Common characteristics that were bred into domesticated plants include grains that did not shatter to allow easier harvesting, uniform ripening, shorter lifespans that translate to faster growing, loss of toxic compounds, and productivity.[11]:2730 Some plants, like the Banana, were able to be propagated by vegetative cloning. Offspring often did not contain seeds, and therefore sterile. However, these offspring were usually juicier and larger. Propagation through cloning allows these mutant varieties to be cultivated despite their lack of seeds.[11]:31

Hybridization was another way that rapid changes in plant’s makeup were introduced. It often increased vigor in plants, and combined desirable traits together. Hybridization most likely first occurred when humans first grew similar, yet slightly different plants in close proximity.[11]:32Triticum aestivum, wheat used in baking bread, is an allopolyploid. Its creation is the result of two separate hybridization events.[12]

Grafting can transfer chloroplasts (specialised DNA in plants that can conduct photosynthesis), mitichondrial DNA and the entire cell nucleus containing the genome to potentially make a new species making grafting a form of natural genetic engineering.[13]

X-rays were first used to deliberately mutate plants in 1927. Between 1927 and 2007, more than 2,540 genetically mutated plant varieties had been produced using x-rays.[14]

Various genetic discoveries have been essential in the development of genetic engineering. Genetic inheritance was first discovered by Gregor Mendel in 1865 following experiments crossing peas. Although largely ignored for 34 years he provided the first evidence of hereditary segregation and independent assortment.[15] In 1889 Hugo de Vries came up with the name “(pan)gene” after postulating that particles are responsible for inheritance of characteristics[16] and the term “genetics” was coined by William Bateson in 1905.[17] In 1928 Frederick Griffith proved the existence of a “transforming principle” involved in inheritance, which Avery, MacLeod and McCarty later (1944) identified as DNA. Edward Lawrie Tatum and George Wells Beadle developed the central dogma that genes code for proteins in 1941. The double helix structure of DNA was identified by James Watson and Francis Crick in 1953.

As well as discovering how DNA works, tools had to be developed that allowed it to be manipulated. In 1970 Hamilton Smiths lab discovered restriction enzymes that allowed DNA to be cut at specific places and separated out on an electrophoresis gel. This enabled scientists to isolate genes from an organism’s genome.[18]DNA ligases, that join broken DNA together, had been discovered earlier in 1967[19] and by combining the two enzymes it was possible to “cut and paste” DNA sequences to create recombinant DNA. Plasmids, discovered in 1952,[20] became important tools for transferring information between cells and replicating DNA sequences. Frederick Sanger developed a method for sequencing DNA in 1977, greatly increasing the genetic information available to researchers. Polymerase chain reaction (PCR), developed by Kary Mullis in 1983, allowed small sections of DNA to be amplified and aided identification and isolation of genetic material.

As well as manipulating the DNA, techniques had to be developed for its insertion (known as transformation) into an organism’s genome. Griffiths experiment had already shown that some bacteria had the ability to naturally take up and express foreign DNA. Artificial competence was induced in Escherichia coli in 1970 when Morton Mandel and Akiko Higa showed that it could take up bacteriophage after treatment with calcium chloride solution (CaCl2).[21] Two years later, Stanley Cohen showed that CaCl2 treatment was also effective for uptake of plasmid DNA.[22] Transformation using electroporation was developed in the late 1980s, increasing the efficiency and bacterial range.[23] In 1907 a bacterium that caused plant tumors, Agrobacterium tumefaciens, was discovered and in the early 1970s the tumor inducing agent was found to be a DNA plasmid called the Ti plasmid.[24] By removing the genes in the plasmid that caused the tumor and adding in novel genes researchers were able to infect plants with A. tumefaciens and let the bacteria insert their chosen DNA into the genomes of the plants.[25]

In 1972 Paul Berg utilised restriction enzymes and DNA ligases to create the first recombinant DNA molecules. He combined DNA from the monkey virus SV40 with that of the lambda virus.[26] Herbert Boyer and Stanley Norman Cohen took Berg’s work a step further and introduced recombinant DNA into a bacterial cell. Cohen was researching plasmids, while Boyers work involved restriction enzymes. They recognised the complementary nature of their work and teamed up in 1972. Together they found a restriction enzyme that cut the pSC101 plasmid at a single point and were able to insert and ligate a gene that conferred resistance to the kanamycin antibiotic into the gap. Cohen had previously devised a method where bacteria could be induced to take up a plasmid and using this they were able to create a bacteria that survived in the presence of the kanamycin. This represented the first genetically modified organism. They repeated experiments showing that other genes could be expressed in bacteria, including one from the toad Xenopus laevis, the first cross kingdom transformation.[27][28][29]

In 1974 Rudolf Jaenisch created a transgenic mouse by introducing foreign DNA into its embryo, making it the worlds first transgenic animal.[30][31] Jaenisch was studying mammalian cells infected with simian virus 40 (SV40) when he happened to read a paper from Beatrice Mintz describing the generation of chimera mice. He took his SV40 samples to Mintz’s lab and injected them into early mouse embryos expecting tumours to develop. The mice appeared normal, but after using radioactive probes he discovered that the virus had integrated itself into the mice genome.[32] However the mice did not pass the transgene to their offspring. In 1981 the laboratories of Frank Ruddle, Frank Constantini and Elizabeth Lacy injected purified DNA into a single-cell mouse embryo and showed transmission of the genetic material to subsequent generations.[33][34]

The first genetically engineered plant was tobacco, reported in 1983.[35] It was developed by Michael W. Bevan, Richard B. Flavell and Mary-Dell Chilton by creating a chimeric gene that joined an antibiotic resistant gene to the T1 plasmid from Agrobacterium. The tobacco was infected with Agrobacterium transformed with this plasmid resulting in the chimeric gene being inserted into the plant. Through tissue culture techniques a single tobacco cell was selected that contained the gene and a new plant grown from it.[36]

The development of genetic engineering technology led to concerns in the scientific community about potential risks. The development of a regulatory framework concerning genetic engineering began in 1975, at Asilomar, California. The Asilomar meeting recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology.[37] The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health (NIH) formed a recombinant DNA advisory committee.[38] This was followed by other regulatory offices (the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), effectively making all recombinant DNA research tightly regulated in the USA.[39]

In 1982 the Organization for Economic Co-operation and Development (OECD) released a report into the potential hazards of releasing genetically modified organisms into the environment as the first transgenic plants were being developed.[40] As the technology improved and genetically organisms moved from model organisms to potential commercial products the USA established a committee at the Office of Science and Technology (OSTP) to develop mechanisms to regulate the developing technology.[39] In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.[41] In the late 1980s and early 1990s, guidance on assessing the safety of genetically engineered plants and food emerged from organizations including the FAO and WHO.[42][43][44][45]

The European Union first introduced laws requiring GMO’s to be labelled in 1997.[46] In 2013 Connecticut became the first state to enact a labeling law in the USA, although it would not take effect until other states followed suit.[47]

The ability to insert, alter or remove genes in model organisms allowed scientists to study the genetic elements of human diseases.[48]Genetically modified mice were created in 1984 that carried cloned oncogenes that predisposed them to developing cancer.[49] The technology has also been used to generate mice with genes knocked out. The first recorded knockout mouse was created by Mario R. Capecchi, Martin Evans and Oliver Smithies in 1989. In 1992 oncomice with tumor suppressor genes knocked out were generated.[49] Creating Knockout rats is much harder and only became possible in 2003.[50][51]

After the discovery of microRNA in 1993,[52]RNA interference (RNAi) has been used to silence an organism’s genes.[53] By modifying an organism to express microRNA targeted to its endogenous genes, researchers have been able to knockout or partially reduce gene function in a range of species. The ability to partially reduce gene function has allowed the study of genes that are lethal when completely knocked out. Other advantages of using RNAi include the availability of inducible and tissue specific knockout.[54] In 2007 microRNA targeted to insect and nematode genes was expressed in plants, leading to suppression when they fed on the transgenic plant, potentially creating a new way to control pests.[55] Targeting endogenous microRNA expression has allowed further fine tuning of gene expression, supplementing the more traditional gene knock out approach.[56]

Genetic engineering has been used to produce proteins derived from humans and other sources in organisms that normally cannot synthesize these proteins. Human insulin-synthesising bacteria were developed in 1979 and were first used as a treatment in 1982.[57] In 1988 the first human antibodies were produced in plants.[58] In 2000 Vitamin A-enriched golden rice, was the first food with increased nutrient value.[59]

As not all plant cells were susceptible to infection by A. tumefaciens other methods were developed, including electroporation, micro-injection[60] and particle bombardment with a gene gun (invented in 1987).[61][62] In the 1980s techniques were developed to introduce isolated chloroplasts back into a plant cell that had its cell wall removed. With the introduction of the gene gun in 1987 it became possible to integrate foreign genes into a chloroplast.[63]

Genetic transformation has become very efficient in some model organism. In 2008 genetically modified seeds were produced in Arabidopsis thaliana by simply dipping the flowers in an Agrobacterium solution.[64] The range of plants that can be transformed has increased as tissue culture techniques have been developed for different species.

The first transgenic livestock were produced in 1985,[65] by micro-injecting foreign DNA into rabbit, sheep and pig eggs.[66] The first animal to synthesise transgenic proteins in their milk were mice,[67] engineered to produce human tissue plasminogen activator.[68] This technology was applied to sheep, pigs, cows and other livestock.[67]

In 2010 scientists at the J. Craig Venter Institute announced that they had created the first synthetic bacterial genome. The researchers added the new genome to bacterial cells and selected for cells that contained the new genome. To do this the cells undergoes a process called resolution, where during bacterial cell division one new cell receives the original DNA genome of the bacteria, whilst the other receives the new synthetic genome. When this cell replicates it uses the synthetic genome as its template. The resulting bacterium the researchers developed, named Synthia, was the world’s first synthetic life form.[69][70]

In 2014 a bacteria was developed that replicated a plasmid containing an unnatural base pair. This required altering the bacterium so it could import the unnatural nucleotides and then efficiently replicate them. The plasmid retained the unnatural base pairs when it doubled an estimated 99.4% of the time.[71] This is the first organism engineered to use an expanded genetic alphabet.[72]

In 2015 CRISPR and TALENs was used to modify plant genomes. Chinese labs used it to create a fungus-resistant wheat and boost rice yields, while a U.K. group used it to tweak a barley gene that could help produce drought-resistant varieties. When used to precisely remove material from DNA without adding genes from other species, the result is not subject the lengthy and expensive regulatory process associated with GMOs. While CRISPR may use foreign DNA to aid the editing process, the second generation of edited plants contain none of that DNA. Researchers celebrated the acceleration because it may allow them to “keep up” with rapidly evolving pathogens. The U.S. Department of Agriculture stated that some examples of gene-edited corn, potatoes and soybeans are not subject to existing regulations. As of 2016 other review bodies had yet to make statements.[73]

In 1976 Genentech, the first genetic engineering company was founded by Herbert Boyer and Robert Swanson and a year later and the company produced a human protein (somatostatin) in E.coli. Genentech announced the production of genetically engineered human insulin in 1978.[74] In 1980 the U.S. Supreme Court in the Diamond v. Chakrabarty case ruled that genetically altered life could be patented.[75] The insulin produced by bacteria, branded humulin, was approved for release by the Food and Drug Administration in 1982.[76]

In 1983 a biotech company, Advanced Genetic Sciences (AGS) applied for U.S. government authorization to perform field tests with the ice-minus strain of P. syringae to protect crops from frost, but environmental groups and protestors delayed the field tests for four years with legal challenges.[77] In 1987 the ice-minus strain of P. syringae became the first genetically modified organism (GMO) to be released into the environment[78] when a strawberry field and a potato field in California were sprayed with it.[79] Both test fields were attacked by activist groups the night before the tests occurred: “The world’s first trial site attracted the world’s first field trasher”.[78]

The first genetically modified crop plant was produced in 1982, an antibiotic-resistant tobacco plant.[80] The first field trials of genetically engineered plants occurred in France and the USA in 1986, tobacco plants were engineered to be resistant to herbicides.[81] In 1987 Plant Genetic Systems, founded by Marc Van Montagu and Jeff Schell, was the first company to genetically engineer insect-resistant plants by incorporating genes that produced insecticidal proteins from Bacillus thuringiensis (Bt) into tobacco.[82]

Genetically modified microbial enzymes were the first application of genetically modified organisms in food production and were approved in 1988 by the US Food and Drug Administration.[83] In the early 1990s, recombinant chymosin was approved for use in several countries.[83][84] Cheese had typically been made using the enzyme complex rennet that had been extracted from cows’ stomach lining. Scientists modified bacteria to produce chymosin, which was also able to clot milk, resulting in cheese curds.[85] The Peoples Republic of China was the first country to commercialize transgenic plants, introducing a virus-resistant tobacco in 1992.[86] In 1994 Calgene attained approval to commercially release the Flavr Savr tomato, a tomato engineered to have a longer shelf life.[87] Also in 1994, the European Union approved tobacco engineered to be resistant to the herbicide bromoxynil, making it the first genetically engineered crop commercialized in Europe.[88] In 1995 Bt Potato was approved safe by the Environmental Protection Agency, after having been approved by the FDA, making it the first pesticide producing crop to be approved in the USA.[89] In 1996 a total of 35 approvals had been granted to commercially grow 8 transgenic crops and one flower crop (carnation), with 8 different traits in 6 countries plus the EU.[81]

By 2010, 29 countries had planted commercialized biotech crops and a further 31 countries had granted regulatory approval for transgenic crops to be imported.[90] In 2013 Robert Fraley (Monsantos executive vice president and chief technology officer), Marc Van Montagu and Mary-Dell Chilton were awarded the World Food Prize for improving the “quality, quantity or availability” of food in the world.[91]

The first genetically modified animal to be commercialised was the GloFish, a Zebra fish with a fluorescent gene added that allows it to glow in the dark under ultraviolet light.[92] The first genetically modified animal to be approved for food use was AquAdvantage salmon in 2015.[93] The salmon were transformed with a growth hormone-regulating gene from a Pacific Chinook salmon and a promoter from an ocean pout enabling it to grow year-round instead of only during spring and summer.[94]

Opposition and support for the use of genetic engineering has existed since the technology was developed.[78] After Arpad Pusztai went public with research he was conducting in 1998 the public opposition to genetically modified food increased.[95] Opposition continued following controversial and publicly debated papers published in 1999 and 2013 that claimed negative environmental and health impacts from genetically modified crops.[96][97]

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History of genetic engineering – Wikipedia

ADRIAN Kibbler wonders whether genetic engineering may be used in the future to prevent illness – Ludlow Advertiser

LEANNE Brownhill was a 26-year-old nurse from Ludlow who sadly died young as a result of a genetic heart condition.

She suffered from cardiomyopathy, a disease that comes in three different forms but essentially damages the heart.

It can unfortunately result in the sudden death of young people who might otherwise have appeared to be fit and healthy.

The case that most people will be aware of is that of the footballer Fabrice Muamba, who aged just 23, suddenly collapsed and nearly died in an FA Cup match between his team Bolton Wanderers and Tottenham Hotspur in 2012.

Indeed, when we hear of a young sportsman or woman who has died suddenly then there is a good chance that cardiomyopathy is responsible.

One of the problems with this disease is that it can be difficult to diagnose and can bring with it no obvious symptoms although in some cases there may be shortness of breath or unexplained fainting.

When the disease is diagnosed various treatments are available that can include the use of various drugs and in some cases the fitting on a defibrillator type device to kick in if the heart fails.

However, medical experts are saying that a new technique could free people of this condition that is caused by inheriting a faulty gene.

The latest breakthrough suggests that not only can the faulty gene be identified but that it can also be repaired.

Now it is important to be cautious because even if this can be advanced it is not likely to widely available anytime soon. However, the potential is huge and there would appear to be reason to hope that the technique could also be applied to other inherited conditions.

The medical and scientific issues around this are only a part of the story because this is genetic engineering.

Of course, it is desirable that when people become ill they receive the best possible treatment but this is not the same thing as genetic engineering.

Some people will argue that if medicine gives us the ability to prevent illness by repairing faulty genes then there is nothing wrong with that. After all medicine enables treatment to be given to babies even when they are in the womb so is this so different?

It has long been the case that babies can be examined for serious medical conditions as part of pre-natal screening and in some cases this can lead to a decision to terminate a pregnancy.

What makes genetic engineering different is that it creates at least potentially the ability to produce a race of perfect people and many of us are very uncomfortable about this.

After all some would argue that it is our difference including in some cases our imperfections that make us special and unique.

No one can give a definitive answer but, for example, would Beethoven have been such a great composer if he not been deaf or Stephen Hawking such a special scientist without his illness?

These are difficult questions but they will become ever more important as medical science advances and what up to now might have been considered science fiction becomes science fact.

Read more here:

ADRIAN Kibbler wonders whether genetic engineering may be used in the future to prevent illness – Ludlow Advertiser

ADRIAN Kibbler wonders whether genetic engineering may be used in the future to prevent illness – Ludlow Advertiser

LEANNE Brownhill was a 26-year-old nurse from Ludlow who sadly died young as a result of a genetic heart condition.

She suffered from cardiomyopathy, a disease that comes in three different forms but essentially damages the heart.

It can unfortunately result in the sudden death of young people who might otherwise have appeared to be fit and healthy.

The case that most people will be aware of is that of the footballer Fabrice Muamba, who aged just 23, suddenly collapsed and nearly died in an FA Cup match between his team Bolton Wanderers and Tottenham Hotspur in 2012.

Indeed, when we hear of a young sportsman or woman who has died suddenly then there is a good chance that cardiomyopathy is responsible.

One of the problems with this disease is that it can be difficult to diagnose and can bring with it no obvious symptoms although in some cases there may be shortness of breath or unexplained fainting.

When the disease is diagnosed various treatments are available that can include the use of various drugs and in some cases the fitting on a defibrillator type device to kick in if the heart fails.

However, medical experts are saying that a new technique could free people of this condition that is caused by inheriting a faulty gene.

The latest breakthrough suggests that not only can the faulty gene be identified but that it can also be repaired.

Now it is important to be cautious because even if this can be advanced it is not likely to widely available anytime soon. However, the potential is huge and there would appear to be reason to hope that the technique could also be applied to other inherited conditions.

The medical and scientific issues around this are only a part of the story because this is genetic engineering.

Of course, it is desirable that when people become ill they receive the best possible treatment but this is not the same thing as genetic engineering.

Some people will argue that if medicine gives us the ability to prevent illness by repairing faulty genes then there is nothing wrong with that. After all medicine enables treatment to be given to babies even when they are in the womb so is this so different?

It has long been the case that babies can be examined for serious medical conditions as part of pre-natal screening and in some cases this can lead to a decision to terminate a pregnancy.

What makes genetic engineering different is that it creates at least potentially the ability to produce a race of perfect people and many of us are very uncomfortable about this.

After all some would argue that it is our difference including in some cases our imperfections that make us special and unique.

No one can give a definitive answer but, for example, would Beethoven have been such a great composer if he not been deaf or Stephen Hawking such a special scientist without his illness?

These are difficult questions but they will become ever more important as medical science advances and what up to now might have been considered science fiction becomes science fact.

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ADRIAN Kibbler wonders whether genetic engineering may be used in the future to prevent illness – Ludlow Advertiser

Listening for the Public Voice – Slate Magazine

Jupiterimages/Thinkstock

On Aug. 3, the scientific article in Nature finally gave us some facts about the much-hyped experiments that involved editing the genomes of human embryos at the Center for Embryonic Cell and Gene Therapy at Oregon Health and Science University. The story had broken in late July in Technology Review, spurring profuse hand-wringing and discussion. But until we saw the scientific paper, it was not clear what cells and methods were used, what genes were edited, or what the results were.

Now we know more, and while the paper demonstrates the possibility of genome editing of human embryos, it raises more questions than it answers. It is a useful demonstration of technical promise, though not an immediate prelude to the birth of a genome-edited baby. But the process by which the news emerged is also an ominous harbinger of the discombobulated way the debate about genetically altering human embryos is likely to unfold. We need open, vigorous debate that captures the many, often contradictory, moral views of Americans. Yet what we are likely to get is piecemeal, fragmented stories of breakthroughs with incomplete details, more sober publication in science journals that appear later, news commentary that lasts a few days, and very little systematic effort to think through what policy should be.

The science underlying this news cycle about human genome editing builds on a technique first developed six years ago by studying how bacteria alter DNA. CRISPR genome editing is the most recent, and most promising, way to introduce changes into DNA. It is faster, easier, and cheaper than previous methods and should eventually be more precise and controllablewhich is why it may one day be available for clinical use in people.

Though headlines about the study discussed designer babies, researchers prefer to emphasize how these techniques could help stop devastating genetic disorders. The Oregon experiments with human embryo cells corrected disease-associated DNA variants associated with heart muscle wasting that can cause heart failure. The treated embryos were alive for only a few days and were never intended to become a human baby. They were, however, human embryos deliberately created for the research.

U.S. guidance in this area is sparse and reflects the lack of societal consensus. In 1994, when the federal government was contemplating funding for research involving human embryos, the NIH Embryo Research Panel concluded that just this kind of experiment was ethically appropriate. But within hours of that reports release, then-President Bill Clinton announced he did not agree with creating embryos in order to do research on them.

The United States currently has just two policies relevant to genomic editing of human embryos. The first blocks federal funding: On April 28, 2015, Francis Collins, director of the National Institutes of Health, stated, NIH will not fund any use of gene-editing technologies in human embryos. This is not embedded in statute or formal executive order, but members of Congress are fully aware of it and it is, in effect, a federal policy. NIH can (and does) fund genome editing of nonembryonic cells that might be used to treat cancer and for other possible therapeutic purposes, but not embryonic cells that would have their effect by creating humans with germline alterations.

Second, Congress has prohibited the Food and Drug Administration from reviewing research in which a human embryo is intentionally created or modified to include a heritable genetic modification. This language comes from a rider to FDAs annual appropriations. Yet use of human embryonic cells for treatment should be subject to FDA regulation. So this language in effect means alterations of embryonic cells cannot be done in the United States if there is any intent to treat a human being, including implantation of an altered embryo into a womans uterus. This will remain true so long as the rider is included in FDAs annual appropriations. The federal government thus has two relevant policies, both of which take federal agencies out of the action: One removes NIH funding, and the other precludes FDA oversight of genome-edited human embryos.

This leaves privately funded research that has no direct therapeutic purpose, such as with the Oregon experiments. The funding came from OHSU itself; South Korean Basic Research Funds; the municipal government of Shenzhen, China; and several private philanthropies (Chapman, Mathers, Helmsley, and Moxie). The research complies with recommendations to study the basic cellular processes of genome editing, keeping an eye on possible future clinical use but only so long as the work does not attempt to create a human pregnancy.

By coincidence, on the same day the Nature paper came out, the American Journal of Human Genetics also published a thoughtful 10-page position statement about germline genome editing from the American Society for Human Genetics endorsed by many other genetic and reproductive medicine organizations from all over the world. It reviews recommendations of the National Academies of Sciences, Engineering, and Medicine, several international and U.S.-based organizations and commissions, and makes several recommendations of its own, concluding it is inappropriate to perform germline gene editing that culminates in human pregnancy, but also there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications. Indeed, the statement argues for public funding. Finally, it urges research to proceed only with compelling medical rationale, strong oversight, and a transparent public process to solicit and incorporate stakeholder input.

So is there a problem here? It is truly wonderful that medical and scientific organizations have addressed genome editing. It is, however, far from sufficient. Reports and scientific consensus statements inform the policy debate but cannot resolve it. All of the reports on genome editing call for robust public debate, but the simple fact is that embryo research has proven highly divisive and resistant to consensus, and it is far from clear how to know when there is enough thoughtful deliberation to make policy choices. Its significant that none of the reports have emerged from a process that embodied such engagement. The Catholic Church, evangelical Christians, and concerned civic action groups who view embryo research as immoral are not likely to turn to the National Academies of Sciences, Engineering and Medicine, the American Society for Human Genetics, the Hinxton Group, the Nuffield Council on Bioetics, or other scientific and medical organizations for their primary counsel. They may well listen to scientists, but religious and moral doctrine will get greater weight. Yet religious groups highly critical of embryo research are part of the political systemand whether we embrace this sort of genome editing in the United States is a political question, not a purely technical one.

Reports and scientific consensus statements inform the policy debate but cannot resolveit.

Addressing the political questions will be extremely difficult. The U.S. government is poorly positioned to mediate the policy debate in a way that recognizes and addresses our complex moral pluralism. NIH and FDA are two of the most crucial agencies, but current policies remove them from line authority, and with good reason, given that engaging in this debate could actually endanger the agencies other vital missions. International consensus about genome editing of human embryos remains no more likely than about embryo research in general: Some countries ban it while others actively promote and fund it. Private foundations dont have the mandate or incentive to mediate political debate about a controversial technology that rouses the politics of abortion. What private philanthropic organization would willingly take on such a thankless and politically perilous task, and what organization would be credible to the full range of constituencies?

So who can carry out the public engagement that everyone seems to agree we need? The likely answer is no one. This problem occurs with all debate about fraught scientific and technical innovations, but its particularly acute when it touches on highly ossified abortion politics.

The debate about genomic editing of human embryos is unlikely to follow the recommendations for systematic forethought proposed by illustrious research bodies and reports. Given the reactions weve seen to human embryonic stem-cell research in the past two decades, we have ample reason for pessimism. Rather, debate is more likely to progress by reaction to events as researchers make newsoften with the same lack of information we lived with for the last week of July, based on incomplete media accounts and quotes from disparate experts who lacked access to the details. Most of the debate will be quote-to-quote combat in the public media, leavened by news and analysis in scientific and medical journals, but surrounded by controversy in religious and political media. It is not what anyone designing a system would want. But the recommendations for robust public engagement and debate feel a bit vacuous and vague, aspirations untethered to a concrete framework.

Our divisive political system seems fated to make decisions about genomic editing of human embryos mainly amidst conflict, with experts dueling in the public media rather than through a thoughtful and well-informed debate conducted in a credible framework. As the furor over the Oregon experiments begins to dissipate, we await the event that will cause the next flare-up. And so it will continue, skipping from news cycle to news cycle.

History shows that sometimes technical advances settle the issues, at least for most people and in defined contexts. Furor about in vitro fertilization after Louise Brown, the first test tube baby, was born in 1978 gave way to acceptance as grateful parents gave birth to more and more healthy babies and welcomed them into their families. Initial revulsion at heart transplants gave way in the face of success. Anger about prospects for human embryonic stem-cell research might similarly attenuate if practical applications emerge.

Such historical examples show precisely why reflective deliberation remains essential, despite its unlikely success. Momentum tends to carry the research forward. Yet at times we should stop, learn more, and decide actively rather than passively whether to proceed, when, how, and with what outcomes in mind. In the case of genome editing of human embryos, however, it seems likely that technology will make the next move.

This article is part of Future Tense, a collaboration among Arizona State University, New America, and Slate. Future Tense explores the ways emerging technologies affect society, policy, and culture. To read more, follow us on Twitter and sign up for our weekly newsletter.

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Listening for the Public Voice – Slate Magazine

The Impossible Burger wouldn’t be possible without genetic engineering – Grist

The Impossible Burger has had a charmed honeymoon period. Crowds of foodies surged into fancy eateries to try it. Environmentalists and animal rights activists swooned. So did investors: Impossible Foods brought in $75 million during its latest investment round.

Now the backlash is here. The activist organizations Friends of the Earth and the ETC Group dug up documents which they claim show that Impossible Foods ignored FDA warnings about safety and they handed them over to the New York Times.

The ensuing story depicted Impossible Foods as a culinary version of Uber disrupting so rapidly that its running headlong into government regulators. In reality, Impossible Foods has behaved like a pedestrian food company, working hand in hand with the FDA and following a well-worn path to comply with an arcane set of rules.

So why isnt this story a nothingburger?

In a word: GMOs. You see, soy leghemoglobin, or SLH, the key ingredient that makes the Impossible Burger uniquely meaty, is churned out by genetically modified yeast. This is a protein produced with genetic engineering; its a new food ingredient, Dana Perls, senior food and technology campaigner at Friends of the Earth, told me when I asked why theyd singled out Impossible Foods.

The company has never exactly hidden the fact that they used genetic engineering, but they havent put it front and center either. You have to dig into their frequently asked questions to catch that detail and thats a recent edit, according to Perls. When I first looked at the Impossible Foods website, maybe back in March, there was no mention of genetic engineering, she said.(An Impossible Foods spokesperson disputed Perlss claim, saying the FAQ has included references to genetic engineering for at least a year, since before the burgers launch in restaurants. But areview of cached webpages suggests the references were added in June.*)

By tiptoeing around this issue, Impossible Foods set themselves up for a takedown by anti-GMO campaigners. These groups monitor new applications of genetic engineering, watch for potentially incriminating evidence, then work with journalists to publicize it. In 2014, Ecover, a green cleaning company, announced it was using oils made by algae as part of its pledge to remove palm oil a major driver of deforestation from its products. When Friends of the Earth and the ETC Group figured out the algae was genetically engineered, they pinged the same Times writer. Ecover quickly went back to palm oil.

When I asked Impossible Foods founder Pat Brown about the GMO question, he said he didnt think that battle was theirs to fight. After all, the SLH may be produced by transgenic yeast, but it isnt a GMO itself. He also pointed out that this isnt unusual: nearly all cheese contains a GMO-produced enzyme.

But now, Friends of the Earth and the ETC Group have brought their battle to Impossible Foods doorstep. (In a blistering series of responses to the New York Times article, the company charged it was chock full of factual errors and misrepresentations and was instigated by an extremist anti-science group.) The FDA documents handed over to the Times include worrying sentences like this one: FDA stated that the current arguments at hand, individually and collectively, were not enough to establish the safety of SLH for consumption.

If FDA officials say your company hasnt done enough to convince them that a new ingredient is safe, arent you supposed to stop selling it?

Not according to a risk expert at Arizona State University who reviewed the documents released by activists. There are no indications that they should have pulled this off the market, Andrew Maynard told me.

Thats just not how the food safety review process works, said Gary Yingling, a former FDA official now helping Impossible Foods navigate the bureaucracy. In the United States, its up to the companies themselves to determine if an ingredient is safe. (Not everyone likes that system or thinks the FDA is doing enough to protect public safety, but it is the law.)

Impossible worked with a group of experts at universities who decided in 2014 that their burger was safe. SLH, it turns out, grows naturally in the roots of soy plants, and the proteins in the burger look a lot like animal proteins a good indicator of safety.

Impossible could have stopped there: Companies, however, can ask the government to weigh in on their research. Sometimes, the FDA asks for more information, which is what happened with Impossible Foods. Its not unusual for the FDA to determine it cant establish the safety of a new ingredient its happened more than 100 times, with substances like Ginkgo biloba, gum arabic, and Spirulina. The FDA has called for more information in about one in every seven of the ingredients companies have asked it to review.

In the case of SLH, the FDA suggested more tests, including rat-feeding trials. Impossible Foods has finished these tests, and academics who have studied the new data confirmed that its generally recognized as safe. Next, Impossible Foods will bring the new evidence back to the FDA, Yingling said.

The criticism raised in this case is really criticism of a system that allows companies to decide for themselves if a new ingredient is OK to add to our food.

If a company decides something is safe, they can go ahead and do it, said Maynard, the risk expert. So thats a weakness in the system. On the other hand, you can argue that once you start this process with the FDA, they have smart scientists who ask tough questions. You can see in those documents that the level of due diligence that a company has to go through is really pretty deep. You really want to make sure that you have a system that doesnt inhibit innovation, but captures as much potentially harmful things as possible.

Each new innovation creates the potential for new hazards. We can block some of those hazards by taking precautions. But how high should we put the precautionary bar?

Impossible Burger could indeed pose some unknown hazard. We just have to weigh that against the known hazards of the present foodborne diseases in meat, greenhouse gases from animal production, the development of antibiotic resistant bacteria in farms, and animal suffering. These are problems which Impossible Foods is trying to solve.

There are other companies trying to solve these problems. (Friends of the Earth notes that the success of non-animal burgers, like the non-GMO Beyond Burger, demonstrates that plant-based animal substitutes can succeed without resorting to genetic engineering.) But its not yet clear that any of these companies including Impossible Foods will be successful in just generating a profit, let alone in replacing the global meat industry. No one knows which startups will pan out. And well probably need to try and discard lots of new things as we shift to a sustainable path.

Trying new things can be risky. Not trying new things and staying on our current trajectory is even more risky.

*This story has been updated to include a response from Impossible Foods about when references to genetic engineering first appeared in its FAQ, and to add information about the FDAs food safety review process.

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The Impossible Burger wouldn’t be possible without genetic engineering – Grist

Genetically Engineering Pigs to Grow Organs for People – The Atlantic

The idea of transplanting organs from pigs into humans has been around for a long time. And for a long time, xenotransplantsor putting organs from one species into anotherhas come up against two seemingly insurmountable problems.

The first problem is fairly intuitive: Pig organs provoke a massive and destructive immune response in humansfar more so than an organ from another person. The second problem is less obvious: Pig genomes are rife with DNA sequences of viruses that can infect human cells. In the 1990s, the pharmaceutical giant Novartis planned to throw as much $1 billion at animal-to-human transplant research, only to shutter its research unit after several years of failed experiments.

Quite suddenly, however, solving these two problems has become much easier and much faster thanks to the gene-editing technology CRISPR. With CRISPR, scientists can knock out the pig genes that trigger the human immune response. And they can inactivate the virusescalled porcine endogenous retroviruses, or PERVsthat lurk in the pig genome.

On Thursday, scientists working for a startup called eGenesis reported the birth of 37 PERV-free baby pigs in China, 15 of them still surviving. The black-and-white piglets are now several months old, and they belong to a breed of miniature pigs that will grow no bigger than 150 poundswith organs just the right size for transplant into adult humans.

eGenesis spun out of the lab of the Harvard geneticist George Church, who previously reported inactivating 62 copies of PERV from pig cells in 2015. But the jump from specialized pig cells that grow well in labs to living PERV-free piglets wasnt easy.

We didnt even know we could have viable pigs, says Luhan Yang, a former graduate student in Churchs lab and co-founder of eGenesis. When her team first tried to edit all 62 copies in pig cells that they wanted to turn into embryos, the cells died. They were more sensitive than the specialized cell lines. Eventually Yang and her team figured out a chemical cocktail that could keep these cells alive through the gene-editing process. This technique could be useful in large-scale gene-editing projects unrelated to xenotransplants, too.

When Yang and her team first inactivated PERV from cells in a lab, my colleague Ed Yong suggested that the work was an example of CRISPRs power rather than a huge breakthrough in pig-to-human transplants, given the challenges of immune compatibility. And true, Yang and Church come at this research as CRISPR pioneers, but not experts in transplantation. At a gathering of organ-transplantation researchers last Friday, Church said that his team had identified about 45 genes to make pig organs more compatible with humans, though he was open to more suggestions. I would bet we are not as sophisticated as we should be because weve only been recently invited [to meetings like this], he said. Its an active area of research for eGenesis, though Yang declined to disclose what the company has accomplished so far.

Its great genetic-engineering work. Its an accomplishment to inactivate that many genes, says Joseph Tector, a xenotransplant researcher at the University of Alabama at Birmingham.

Researchers like Tector, who is also a transplant surgeon, have been chipping away at the problem of immune incompatibility for years, though. CRISPR has sped up that research, too. The first pig gene implicated in the human immune response as one involved in making a molecule called alpha-gal. Making a pig that lacked alpha-gal via older genetic-engineering methods took three years. Now from concept to pig on the ground, its probably six months, says Tector.

Using CRISPR, his team has created a triple-knockout pig that lacks alpha-gal as well as two other genes involved in molecules that that provoke the human immune systems immediate hyperacute rejection of pig organs. For about 30 percent of people, the organs from these triple-knockout pigs should not cause hyperacute rejection. Tector thinks the patients who receive these pig organs could then be treated with the same immunosuppressant drugs that recipients take after an ordinary human-to-human transplant.

Tector and David Cooper, another transplant pioneer, were both recently recruited to the University of Alabama at Birmingham for a xenotransplant program funded by United Therapeutics, a Maryland biotech company that wants to manufacture transplantable organs.

Cooper has transplanted kidneys from pigs engineered by United Therapeutics to have six mutations, which lasted over 200 days in baboons. The result is promising enough that he says human trials could begin soon. These pigs were not created using CRISPR and they are not PERV-free, though recent research has suggested that PERV may not be that harmful to humans. It will be up to the FDA to decide whether pig organs with PERV are safe enough to transplant into people.

If it happens, routine pig-to-human transplants could truly transform healthcare beyond simply increasing the supply. Organs would go from a product of chancesomeone young and healthy dying, unexpectedlyto the product of a standardized manufacturing process. Its going to make such a huge difference that I dont think its possible to conceive of it, says Cooper. Organ transplants would no longer have to be emergency surgeries, requiring planes to deliver organs and surgical teams to scramble at any hour. Organs from pigs can be harvested on a schedule, and surgeries planned for exact times during the day. A patient that comes in with kidney failure could get a kidney the next dayeliminating the need for large dialysis centers. Hospital ICU beds will no longer be taken up by patients waiting for a heart transplant.

With the ability to engineer a donor pig, pig organs can go beyond simply matching a human organ. For example, Cooper says, you could engineer organs to protect themselves from the immune system in the long term, perhaps by making their own localized dose of immunosuppressant drugs.

‘Big Pork’ Wants to Get In on Organ Transplants

At last Fridays summit, Church speculated about making organs resistant to tumors or viruses. When an audience member asked about the possibility of genetically enhancing pig organs to work as well as Michael Phelpss lungs or Usain Bolts heart, he responded, We not only can but should enhance pig organs, even if were opposed to enhancing human beings … They will go through safety and efficacy testing, but part of efficacy is making sure theyre robust and maybe they have to be as robust as Michael Phelps in order to do the job.

Xenotransplantation will raise ethical questions, of course, and genetically enhancing pigs might come uncomfortably close to the plot of Okja. These enhancements are hard to fathom for now because scientist dont yet know what genes to alter if they wanted to make, for example, super lungs. Its taken decades of research to pinpoint the handful of genes that could make pig organs simply compatible with humans. But the technical ability to make any editsor even dozens of edits at oncewith CRISPR is already here.

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Genetically Engineering Pigs to Grow Organs for People – The Atlantic

When genetic engineering is the environmentally friendly choice – GreenBiz

This article originally ran on Ensia.

Which is more disruptive to a plant: genetic engineering or conventional breeding?

It often surprises people to learn that GE commonly causes less disruption to plants than conventional techniques of breeding. But equally profound is the realization that the latest GE techniques, coupled with a rapidly expanding ability to analyze massive amounts of genetic material, allow us to make super-modest changes in crop plant genes that will enable farmers to produce more food with fewer adverse environmental impacts. Such super-modest changes are possible with CRISPR-based genome editing, a powerful set of new genetic tools that is leading a revolution in biology.

My interest in GE crops stems from my desire to provide more effective and sustainable plant disease control for farmers worldwide. Diseases often destroy 10 to 15 percent of potential crop production, resulting in global losses of billions of dollars annually. The risk of disease-related losses provides an incentive to farmers to use disease-control products such as pesticides.

One of my strongest areas of expertise is in the use of pesticides for disease control. Pesticides certainly can be useful in farming systems worldwide, but they have significant downsides from a sustainability perspective. Used improperly, they can contaminate foods. They can pose a risk to farm workers. And they must be manufactured, shipped and applied all processes with a measurable environmental footprint. Therefore, I am always seeking to reduce pesticide use by offering farmers more sustainable approaches to disease management.

It often surprises people to learn that GE commonly causes less disruption to plants than conventional techniques of breeding.

What follows are examples of how minimal GE changes can be applied to make farming more environmentally friendly by protecting crops from disease. They represent just a small sampling of the broad landscape of opportunities for enhancing food security and agricultural sustainability that innovations in molecular biology offer today.

Genetically altering crops the way these examples demonstrate creates no cause for concern for plants or people. Mutations occur naturally every time a plant makes a seed; in fact, they are the very foundation of evolution. All of the food we eat has all kinds of mutations, and eating plants with mutations does not cause mutations in us.

A striking example of how a tiny genetic change can make a big difference to plant health is the strategy of “knocking out” a plant gene that microorganisms can benefit from. Invading microorganisms sometimes hijack certain plant molecules to help themselves infect the plant. A gene that produces such a plant molecule is known as a susceptibility gene.

We can use CRISPR-based genome editing to create a “targeted mutation” in a susceptibility gene. A change of as little as a single nucleotide in the plants genetic material the smallest genetic change possible can confer disease resistance in a way that is absolutely indistinguishable from natural mutations that can happen spontaneously. Yet if the target gene and mutation site are carefully selected, a one-nucleotide mutation may be enough to achieve an important outcome.

A substantial body of research shows proof-of-concept that a knockout of a susceptibility gene can increase resistance in plants to a wide variety of disease-causing microorganisms. An example that caught my attention pertained to powdery mildew of wheat, because fungicides (pesticides that control fungi) are commonly used against this disease. While this particular genetic knockout is not yet commercialized, I personally would rather eat wheat products from varieties that control disease through genetics than from crops treated with fungicides.

Plant viruses are often difficult to control in susceptible crop varieties. Conventional breeding can help make plants resistant to viruses, but sometimes it is not successful.

Early approaches to engineering virus resistance in plants involved inserting a gene from the virus into the plants genetic material. For example, plant-infecting viruses are surrounded by a protective layer of protein, called the “coat protein.” The gene for the coat protein of a virus called papaya ring spot virus was inserted into papaya. Through a process called RNAi, this empowers the plant to inactivate the virus when it invades. GE papaya has been a spectacular success, in large part saving the Hawaiian papaya industry.

Mutations occur naturally every time a plant makes a seed; in fact, they are the very foundation of evolution.

Through time, researchers discovered that even just a very small fragment from one viral gene can stimulate RNAi-based resistance if precisely placed within a specific location in the plants DNA. Even better, they found we can “stack” resistance genes engineered with extremely modest changes in order to create a plant highly resistant to multiple viruses. This is important because, in the field, crops are often exposed to infection by several viruses.

Does eating this tiny bit of a viral gene sequence concern me? Absolutely not, for many reasons, including:

Microorganisms often can overcome plants biochemical defenses by producing molecules called effectors that interfere with those defenses. Plants respond by evolving proteins to recognize and disable these effector molecules. These recognition proteins are called “R” proteins (“R” standing for “resistance”). Their job is to recognize the invading effector molecule and trigger additional defenses. A third interesting approach, then, to help plants resist an invading microorganism is to engineer an R protein so that it recognizes effector molecules other than the one it evolved to detect. We can then use CRISPR to supply a plant with the very small amount of DNA needed to empower it to make this protein.

This approach, like susceptibility knockouts, is quite feasible, based on published research. Commercial implementation will require some willing private- or public-sector entity to do the development work and to face the very substantial and costly challenges of the regulatory process.

The three examples here show that extremely modest engineered changes in plant genetics can result in very important benefits. All three examples involve engineered changes that trigger the natural defenses of the plant. No novel defense mechanisms were introduced in these research projects, a fact that may appeal to some consumers. The wise use of the advanced GE methods illustrated here, as well as others described elsewhere, has the potential to increase the sustainability of our food production systems, particularly given the well-established safety of GE crops and their products for consumption.

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When genetic engineering is the environmentally friendly choice – GreenBiz

Gene Editing Might Mean My Brother Would’ve Never Existed – TIME

CRISPR-CAS9 gene editing complex from Streptococcus pyogenes.Molekuul/Science Photo Library/Getty Images

Reynolds, Ph.D., is Rice Family Postdoctoral Fellow in Bioethics and the Humanities at The Hastings Center.

On August 2nd, scientists achieved a milestone on the path to human genetic engineering. For the first time in the United States, scientists successfully edited the genes of a human embryo . A transpacific team of researchers used CRISPR-Cas9 to correct a mutation that leads to an often devastating heart condition. Responses to this feat followed well-trodden trails. Hype over designer babies. Hope over new tools to cure and curb disease. Some spin, some substance and a good dose of science-speak. But for me, this breakthrough is not just about science or medicine or the future of humankind. Its about faith and family, love and loss. Most of all, its about the life and memory of my brother.

Jason was born with muscle-eye-brain disease. In his case, this included muscular dystrophy, cerebral palsy , severe nearsightedness, hydrocephalus and intellectual disability. He lived past his first year thanks to marvels of modern medicine. A shunt surgery to drain excess cerebrospinal fluid building up around his brain took six attempts, but the seventh succeeded. Aside from those surgeries complications and intermittent illnesses due to a less-than-robust immune system, Jason was healthy. Healthy and happy very happy. His smile could light up a room. Yet, that didnt stop people from thinking that his disability made him worse off. My family and those in our religious community prayed for Jason. Strangers regularly came up to test their fervor. Prayer circles frequently had his name on their lists. We wanted him to be healed. But I now wonder: What, precisely, were we praying for?

Jasons disabilities fundamentally shaped his experience of the world. If praying for his healing meant praying for him to be normal, we were praying for Jason to become someone else entirely. We were praying for a paradox. If I could travel back in time, Id walk up to young, devout Joel and ask: How will Jason still be Jason if God flips a switch and makes him walk and talk and think like you? The answer to that question is hard. Yes, some just prayed for his seizures to stop. Some for his continued well-being. But is that true of most? Is that what I was praying for?

The ableist conflation of disability with disease and suffering is age-old. Just peruse the history of medicine. Decades of eugenic practices. Sanctioned torture of people with intellectual disability. The mutilation of otherwise healthy bodies in the name of functional or aesthetic normality. These stories demonstrate over and over again how easily biomedical research and practice can mask atrocity with benevolence and injustice with progress. Which leads me to ask: What, precisely, are we editing for?

Although muscle-eye-brain disease does not result from a single genetic variant, researchers agree that a single gene, named POMGNT1, plays a large role. Perhaps scientists will soon find a way to correct mutations in that and related genes. Perhaps people will no longer be born with it. But that means there would never be someone like Jason. Those prayers I mentioned above? Science will have retroactively answered them. That thought brings me to tears.

I wish we could cure cancer , relieve undue pain and heal each break and bruise. But I also wish for a world with Jason and people like him in it. I want a world accessible and habitable for people full stop not just the people we design. I worry that in our haste to make people healthy, we are in fact making people we want. We, who say we pray for healing, but in fact pray for others to be like us. We, who say were for reducing disease and promoting health, but support policies and practices aimed instead at being normal. We, who are often still unable to distinguish between positive, world-creating forms of disability and negative, world-destroying forms between Deafness , short stature or certain types of neurodiversity and chronic pain, Tay-Sachs or Alzheimers . It is with great responsibility that we as a society balance along the tightrope of biomedical progress. I long for us to find that balance. Ive certainly not found it for myself. Lest I forget how often weve lost it and how easy it is to fall, I hold dearly onto the living memory of Jason. I no longer pray for paradoxes, but for parity for the promise of a world engineered not for normality, but equality.

But that world will never come if we edit it away.

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Gene Editing Might Mean My Brother Would’ve Never Existed – TIME

It’s Time to Stop Asking Whether Human Genetic Engineering Should Happen and Start Planning to Manage it Safely – HuffPost

The DNA of early human embryos carrying a sequence leading to hypertrophic cardiomyopathya potentially deadly heart defecthas been edited to ensure they would carry a healthy DNA sequence if brought to term. The Nature paper announcing this has reenergized a terrific national and international debate over whether permanent changes in DNA that can be passed from one generation to another should be made. Bioethicists are asking, Should we genetically engineer children? while some potential parents are almost certainly asking, When will this technique be available?

The Should questions bioethicists are asking are probably not relevant. The only question whose answer ultimately matters is: Can techniques like CRISP-R be used to genetically engineer children safely? Because a variety of forces guarantee that if they can be, they will be.

The key questions reliable practitioners must answer are: Can we prove it works? Then: Can it be used safely?. If yes on these questions, then we will see: Who is marketing this technique to potential parents? Finally, we will learn: Where was it done, who did it, and who paid for its use?

We are closer than ever before to using CRISP-R to replace dangerous DNA sequences with those that wont keep a baby from being healthy. Fortunately, this Nature paper leaves many questions Unanswered because the embryos were not allowed to come to term.

Most importantly, we still dont know Could the embryos have developed into viable babies? Just as in 2015 when researchers at Sun Yat-Sen University in China didnt implant engineered embryos into a womans womb, the scientists who published in Nature recently didnt feel ready (and didnt have permission) to try this potentially enormous step. As experiments proceed, this question will, at some point, be answered.

It will be answered because there is an enormous, proven market for techniques that can be used to ensure that a baby will be born without DNA sequences that can lead to genetically-mediated conditions; many of which are devastating as we have been tragically reminded of late.

Under the best circumstances, in-vitro fertilization leads to a live birth less than half of the time. As a result, whoever tries to see if an embryo that has had targeted DNA repaired using CRISP-R will doubtless prepare a lot of embryos for implanting in quite a few women. When those women are asked to carry these embryos to term we will not know about it. We will probably not find out if none of the embryos come to term successfully.

We *will* know about this procedure if even one baby comes to term and is born with the targeted genetic sequence corrected as intended. Until now, (and maybe even with our new knowledge), any baby brought to term after CRISP-R was used to edit and replace unhealthy DNA would have almost certainly had other DNA damaged in the editing process. This near-certainty and other concerns have held people back from trying to genetically engineer an embryo that they would then bring to term. They could not, until recently, have confidence that only the sequence being targeted has been affected. With this new Nature report, this, at least, is changing.

The results of these newly reported experiments are many steps closer to usability than the Chinese experiments reported in 2015. This is the nature of scientific experimentation, particularly when there is demand for the capability or knowledge being developed.

People try something. It either works or it doesnt. Sometimes when it doesnt work, we learn enough to adjust and try again. If it does work, it often doesnt function exactly the way we expected. Either way, people keep trying until either the technique is perfected or it ultimately proves to be unusable.

This Nature paper is an example of trying something and doing a better job than the first attempt. It does not represent a provably safe and reliable technique . Yet. If market driven research works as it often does, people will work hard to publish data (hopefully from reliable experimental work) suggesting they have a safe and effective technique. Doing so will let them tell some desperate set of wealthy prospective parents: We should be able to use this technique with an acceptable chance of giving you a healthy baby.

Princetons Lee Silver predicted parents desire for gene editing in his Remaking Eden, a book published in 1997. He argued this because people fear sickness or disability and feel strong personal, economic and social pressures to have healthy, beautiful children who should become healthy attractive adults.

People already spend a great deal on molecular techniques like pre-implantation genetic diagnosis (PGD). PGD is regularly used to reduce couples risk of having babies with known (or potential), chromosomal abnormalities and/or single gene mutations that can lead to thousands of DNA-mediated conditions.

As I showed in my Genetics dissertation published from Yale in 2004, different countries respond differently to controversial science like this. Similarly, different individuals responses are equally diverse. One poll indicates nearly half of Americans would use gene editing technology to prevent possible DNA-mediated conditions in their children. Policy makers who object to the technology therefore have a problem: if they succeed in blocking it somewhere, research and real world experience indicate other governments may well permit its use. If this happens, these techniques will be available to anyone wealthy and desperate enough to find providers with the marketingand hopefully scientificskill needed to sell people on trying them.

This gene editing controversy is a reminder that we are losing the capacity to effectively ask, Should we? As our knowledge of science grows, becomes more globalized, and is increasingly easy to acquire for people with different morals, needs and wants, we must soon be ready to ask, Can we? and ultimately, Will someone? Their answers will give us the best chance to ensure any babies that may come from any technique described as genetic engineering are born healthy, happy, and able to thrive.

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Link:

It’s Time to Stop Asking Whether Human Genetic Engineering Should Happen and Start Planning to Manage it Safely – HuffPost

Global: Engineering the Future of Our Food – STRATFOR

Biotechnology company, AquaBounty Technologies, sold 4.5 metric tons of genetically modified salmon Aug. 4 on the open Canadian market. The seminal transaction occurred after Canadian authorities approved the fish for human consumption in 2016. The sale marks a long-awaited victory for the company that has spent the better part of three decades working to bring their fast-growing salmon to dinner tables.

The modifications, which incorporate genes from two additional species of fish (the Chinook salmon and ocean pout), enable the salmon to grow in about half the time as non-engineered species. AquaBounty already has plans to expand its Panamanian production to facilities in Prince Edward Island, Canada. Additionally, the company is awaiting approval to begin production at recently acquired facilities in Indiana. Proponents see this type of engineering as a solution to growing uncertainty over supply in the market. Traditional salmon producing areas, however, have voiced objections to growing competition in a market.

Those objections have stalled the sale of the AquaBounty product in the United States, despite approval from the Food and Drug Administration (FDA) six months before the Canadian government. Specifically, debate surrounding labeling requirements (heavily backed by Alaskan Senator Lisa Murkowski) have delayed the sale of genetically modified salmon. But this is just the beginning. The journey from tank to table is important for more than just the salmon industry. Livestock producers of a number of different species also are waiting in anticipation for how this will play out. Genetic engineering trials for pigs, cattle and goats are underway. How fast policy catches up to technological developments will in part dictate the rate of adoption of biotechnology throughout the agricultural sector (in the United States and globally). This case, and other early endeavors, have the ability to set the precedent for others to follow, especially as genetic engineering techniques improve and become cheaper.

As we see genetic engineering techniques progress and knowledge spread about the purpose of specific genes, policy surrounding the sale of manipulated organisms will become crucial to the sector. In January, the U.S. Food and Drug Administration opened up a commenting period (that closed in June) on expanding the scope of its “Guidance for Industry #187.” In non-legal speak, that is the directive on requirements for genetically modified or engineered labeling. In addition to the recombinant DNA technology that was prevalent in the later part of the 20th century (and what AquaBounty used to develop the salmon in question), the new language would include improved methods, including the much-touted CRISPR.

Meanwhile, the continued development of biotechnology remains a key strategy for both the United States and China, and both countries will likely remain undeterred from this approach moving forward. External drivers, demographics, changing dietary patterns and climate change are going to force producers to do more with less. Biotechnology (gene editing and the increased knowledge of genomic purpose) allow for better control of beneficial traits, whether it is a faster growing fish or pigs that emit less phosphorus. As its relevance grows, we will also see an increased emphasis on biotechnology in trade negotiations, especially as policies and protocols seek to better address emerging technologies.

More:

Global: Engineering the Future of Our Food – STRATFOR

Genetic Engineering with Strict Guidelines? Ha! – Discovery Institute

Human genetic engineering is moving forward exponentially and there is still no meaningful societal, regulatory, or legislative conversation about whether, how, and to what extent we should permit the human genome to be altered in ways that flow down the generations.

But dont worry. The Scientists assure us, when that can be done, there will (somehow) be STRICT OVERSIGHT. From the AP story:

And lots more research is needed to tell if its really safe, added Britains [Robin] Lovell-Badge. He and [Johns Hopkins University bioethicist Jeffrey] Kahn were part of a National Academy of Sciences report earlier this year that said if germline editing ever were allowed, it should be only for serious diseases with no good alternatives and done with strict oversight.

Please!No more! When I laugh this hard it makes mystomach hurt.

Heres the problem: Strict guidelines rarely are strict and they almost never offer permanent protection. Theyare ignored, unenforced, or stretched over time until they, essentially, cease to exist.

Thats awful with actions such as euthanasia. But wecant let that kind of pretense rule the day withtechnologies that could prove to be among themost powerful and potentially destructive inventions in human history. Indeed, other than nuclear weapons, I cant think of a technology with more destructive potential.

Strict oversight will have to include legal limitations and clear boundaries, enforced bystiff criminalpenalties, civil remedies, and international protocols.

They wont be easy to craft and it will take significant time to work through all of the scientific and ethical conundrums.But we havent yet made a beginning. If we wait until what may be able to be done actually can be done, it will be too late.

Photo: Genetically engineering mice, via Wikicommons.

Cross-posted at The Corner.

Read the rest here:

Genetic Engineering with Strict Guidelines? Ha! – Discovery Institute

When genetic engineering is the environmentally friendly choice – Genetic Literacy Project

Thisarticleoriginally appeared at Ensia and has been republished here with permission.

Which is more disruptive to a plant: genetic engineering or conventional breeding?

It often surprises people to learn that GE commonly causes less disruption to plants than conventional techniques of breeding. But equally profound is the realization that the latest GE techniques, coupled with a rapidly expanding ability to analyze massive amounts of genetic material, allow us to make super-modest changes in crop plant genes that will enable farmers to produce more food with fewer adverse environmental impacts. Such super-modest changes are possible with CRISPR-based genome editing, a powerful set of new genetic tools that is leading a revolution in biology.

My interest in GE crops stems from my desire to provide more effective and sustainable plant disease control for farmers worldwide. Diseases often destroy 10 to 15 percent of potential crop production, resulting in global losses of billions of dollars annually. The risk of disease-related losses provides an incentive to farmers to use disease-control products such as pesticides. One of my strongest areas of expertise is in the use of pesticides for disease control. Pesticides certainly can be useful in farming systems worldwide, but they have significant downsides from a sustainability perspective. Used improperly, they can contaminate foods. They can pose a risk to farm workers. And they must be manufactured, shipped and applied all processes with a measurable environmental footprint. Therefore, I am always seeking to reduce pesticide use by offering farmers more sustainable approaches to disease management.

What follows are examples of how minimal GE changes can be applied to make farming more environmentally friendly by protecting crops from disease. They represent just a small sampling of the broad landscape of opportunities for enhancing food security and agricultural sustainability that innovations in molecular biology offer today.

Genetically altering crops the way these examples demonstrate creates no cause for concern for plants or people. Mutations occur naturally every time a plant makes a seed; in fact, they are the very foundation of evolution. All of the food we eat has all kinds of mutations, and eating plants with mutations does not cause mutations in us.

Knocking Out Susceptibility

A striking example of how a tiny genetic change can make a big difference to plant health is the strategy of knocking out a plant gene that microorganisms can benefit from. Invading microorganisms sometimes hijack certain plant molecules to help themselves infect the plant. A gene that produces such a plant molecule is known as a susceptibility gene.

We can use CRISPR-based genome editing to create a targeted mutation in a susceptibility gene. A change of as little as a single nucleotide in the plants genetic material the smallest genetic change possible can confer disease resistance in a way that is absolutely indistinguishable from natural mutations that can happen spontaneously. Yet if the target gene and mutation site are carefully selected, a one-nucleotide mutation may be enough to achieve an important outcome.

There is a substantial body of research showing proof-of-concept that a knockout of a susceptibility gene can increase resistance in plants to a very wide variety of disease-causing microorganisms. An example that caught my attention pertained to powdery mildew of wheat, because fungicides (pesticides that control fungi) are commonly used against this disease. While this particular genetic knockout is not yet commercialized, I personally would rather eat wheat products from varieties that control disease through genetics than from crops treated with fungicides.

The Power of Viral Snippets

Plant viruses are often difficult to control in susceptible crop varieties. Conventional breeding can help make plants resistant to viruses, but sometimes it is not successful.

Early approaches to engineering virus resistance in plants involved inserting a gene from the virus into the plants genetic material. For example, plant-infecting viruses are surrounded by a protective layer of protein, called the coat protein. The gene for the coat protein of a virus called papaya ring spot virus was inserted into papaya. Through a process called RNAi, this empowers the plant to inactivate the virus when it invades. GE papaya has been a spectacular success, in large part saving the Hawaiian papaya industry.

Through time, researchers discovered that even just a very small fragment from one viral gene can stimulate RNAi-based resistance if precisely placed within a specific location in the plants DNA. Even better, they found we can stack resistance genes engineered with extremely modest changes in order to create a plant highly resistant to multiple viruses. This is important because, in the field, crops are often exposed to infection by several viruses.

Does eating this tiny bit of a viral gene sequence concern me? Absolutely not, for many reasons, including:

Tweaking Sentry Molecules

Microorganisms can often overcome plants biochemical defenses by producing molecules called effectors that interfere with those defenses. Plants respond by evolving proteins to recognize and disable these effector molecules. These recognition proteins are called R proteins (R standing for resistance). Their job is to recognize the invading effector molecule and trigger additional defenses. A third interesting approach, then, to help plants resist an invading microorganism is to engineer an R protein so that it recognizes effector molecules other than the one it evolved to detect. We can then use CRISPR to supply a plant with the very small amount of DNA needed to empower it to make this protein.

This approach, like susceptibility knockouts, is quite feasible, based on published research. Commercial implementation will require some willing private- or public-sector entity to do the development work and to face the very substantial and costly challenges of the regulatory process.

Engineered for Sustainability

The three examples here show that extremely modest engineered changes in plant genetics can result in very important benefits. All three examples involve engineered changes that trigger the natural defenses of the plant. No novel defense mechanisms were introduced in these research projects, a fact that may appeal to some consumers. The wise use of the advanced GE methods illustrated here, as well as others described elsewhere, has the potential to increase the sustainability of our food production systems, particularly given the well-established safety of GE crops and their products for consumption.

Read the original here:

When genetic engineering is the environmentally friendly choice – Genetic Literacy Project

Experts Call on US to Start Funding Scientists to Genetically Engineer Human Embryos – Gizmodo

Edited human embryos. Image: OHSYU

This week, news of a major scientific breakthrough brought a debate over genetically engineering humans front and center. For the first time ever, scientists genetically engineered a human embryo on American soil in order to remove a disease-causing mutation. It was the fourth time ever that such a feat has been published on, and with the most success to date. It may still be a long way off, but it seems likely that one day we will indeed have to grapple with the sticky, complicated philosophical mess of whether, and in which cases, genetically engineering a human being is morally permissible.

On the heels of this news, on Thursday a group of 11 genetics groups released policy recommendations for whats known as germline editingor altering the human genome in such a way that those changes could be passed down to future generations. The statement, from groups including the American Society for Reproductive Medicine, said that doctors should not yet entertain implanting an altered embryo in a human womb, a step which would be against the law in the United States. But they also argued that there is no reason not to use public money to fund basic research on human germline editing, contrary to a National Institutes of Health policy that has banned funding research involving editing human embryo DNA.

Currently, there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications of gene editing, they wrote. There should be no prohibition on making public funds available to support this research.

Safety, ethical concerns and the impact germline editing might have on societal inequality, they wrote, would all have to be worked out before such technology is ready for the clinic.

Genetic disease, once a universal common denominator, could instead become an artifact of class, geographic location, and culture, they wrote. In turn, reduced incidence and reduced sense of shared risk could affect the resources available to individuals and families dealing with genetic conditions.

If and when embryo editing is ready for primetime, the group concluded that there would need to be a good medical reason to use such technology, as well as a transparent public debate. Some have questioned the medical necessity of embryo editing, arguing that genetic screening combined with in vitro fertilization could allow doctors to simply pick disease-free eggs to implant, achieving the same results via a method that is less morally-fraught.

In February, the National Academy of Sciences released a 261-page report that also gave a cautious green light to human gene-editing, endorsing the practice for purposes of curing disease and for basic research, but determining that uses such as creating designer babies are unethical. Other nations, like China and the UK, have forged ahead with human embryo editing for basic research, though there have been no published accounts of research past the first few days of early embryo development.

Given the way the culture, religion and regional custom impact attitudes toward genetically-engineering human life, its safe to say that this debate will not be an easy one to settle. As the policy recommendations point out, views on the matter vary drastically not just across the US, but around the world, and yet one nation making the decision to go ahead with implanting edited embryos will create a world in which that technology exists for everyone.

In the meantime, though, there are still more than a few kinks to work out in the science before were faced with these questions in the real world.

Read more:

Experts Call on US to Start Funding Scientists to Genetically Engineer Human Embryos – Gizmodo

What is genetic engineering? | Facts | yourgenome.org

Genetic engineering refers to the direct manipulation of DNA to alter an organisms characteristics (phenotype) in a particular way.

To help explain the process of genetic engineering we have taken the example of insulin, a protein that helps regulate the sugar levels in our blood.

The genetic engineering process

An illustration showing how genetic modification is used to produce insulin in bacteria. Image credit: Genome Research Limited

Alzheimers disease and the worm

This page was last updated on 2017-02-17

Read more:

What is genetic engineering? | Facts | yourgenome.org


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