Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies, New Life Science …

Toronto, Canada (PRWEB) October 03, 2013

Good Manufacturing Practice (GMP) requires manufacturers of finished bio/pharmaceutical products to effectively clean their facilities and equipment prior to production and disinfect regularly to ensure product safety.

The key to successful facility cleaning is understanding the complete process, including the unique differences between materials cleaning validation and disinfectant efficacy studies, how the two processes are related and the challenges associated with each.

During this presentation you will learn how to establish the best and most cost-effective approach to a cleaning, disinfection and monitoring program, including:

For more information about this event or to register, visit: http://xtalks.com/cleaning-validations-and-disinfectant-studies.ashx.

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com/ContactUs.ashx.

Contact: Karen Lim (416) 977-6555 ext 227 clientservices(at)xtalks(dot)com

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Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies, New Life Science ...

Clinical Laboratory Services Market is Expected to Reach USD 241.37 Billion Globally in 2019: Transparency Market …

ALBANY, New York, October 3, 2013 /PRNewswire/ --

According to a new market report published by Transparency Market Research "Clinical Laboratory Services Market (Clinical Chemistry, Medical Microbiology & Cytology, Human & Tumor Genetics and Other Esoteric Tests) -Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019," the global clinical laboratory services market was valued at USD 162.71 billion in 2012 and is expected to grow at a CAGR of 5.8% from 2013 to 2019, to reach an estimated value of USD 241.37 billion in 2019.

Browse the full report with complete TOC athttp://www.transparencymarketresearch.com/clinical-laboratory-services-market.html

Clinical laboratories refer to the centers for conducting diagnostic testing and related services to identify disease causes, level of progression (stage) of the disease, resultant abnormalities and imbalances in the physiology, and other such factors. Along with processing samples and generating patient reports, players in this market also offer informatics solutions which help in effective data management for the large volume of tests ordered and performed each day. The global market for clinical laboratory services is expected to grow at a CAGR of 5.8% during the forecast period due to the increasing incidence rates of diseases worldwide along with the introduction of newer and sophisticated diagnostic tests.

The market for clinical laboratory services has been segmented by different categories of tests performed such as clinical chemistry, genetic tests, medical microbiology & cytology tests and other esoteric tests. The market for medical microbiology & cytology tests is expected to grow at the highest CAGR of 7.1% during the forecast period due to the increasing burden of infectious diseases globally, that demands large testing volume capacities from clinical laboratories. Although core laboratory tests, which constitute the clinical chemistry market segment, are basic tests extensively conducted across patient populations, this market segment is expected to witness mediocre growth at a CAGR of 5.3%. This is due to the limited scope for innovation in this market in terms of developing newer tests and the growing importance of informatics solutions in the same.

On the basis of geographic regions, this market was studied with reference to North America, Europe, Asia-Pacific and Rest of the World. North America and Asia-Pacific regions are expected to emerge as highly attractive markets for clinical laboratory services in the future, in terms of market revenue and growth respectively. The market is divided into three major types of service providers- clinic-based, hospital-based and stand-alone laboratories. Of these, hospital-based laboratories generate the maximum revenue globally are expected to continue to do so during the forecast period.

The market for clinical laboratory services is fragmented, with Quest Diagnostics, Inc. (U.S.) and Laboratory Corporation of America Holdings (U.S.) dominating the market in terms of revenue generation. Some of the other key players include Sonic Healthcare (Australia), Genoptix Medical Laboratory (U.S.), Labco S.A. (France), Healthscope Ltd. (Australia), Bio-Reference Laboratories (U.S.), and Bioscientia Healthcare (Germany).

Related & Recently Published Reports by Transparency Market Research

The global clinical laboratory services market is segmented as follows:

Clinical Laboratory Services Market, by Test Type

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Clinical Laboratory Services Market is Expected to Reach USD 241.37 Billion Globally in 2019: Transparency Market ...

Durata Therapeutics Presents New Comprehensive Review of the Efficacy and Safety Data of Dalbavancin and New In Vitro …

SAN FRANCISCO, Oct. 2, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (DRTX) today announced a comprehensive review of the efficacy, safety and microbiology data of the company's lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). The data is being presented in six posters at this year's IDWeek 2013(TM), held in San Francisco, Calif., October 2-6, 2013. Among the findings, an integrated analysis of two Phase 3 clinical studies (DISCOVER 1 and 2) showed dalbavancin met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, as well as clinical success at the end of treatment. Sensitivity analyses for both timepoints were also included.i A separate analysis showed that patients achieving cessation of spread of the lesion after 72 hours of antibiotic treatment with dalbavancin have a greater than 90 percent chance of being cured at the end of treatment.ii A pooled summary analysis of the safety profile of dalbavancin based on the Phase 2 and 3 clinical program also found it to be generally well-tolerated and to have a similar safety profile to comparators with fewer adverse events.iii Examination of patients with baseline Gram-positive bacteremia enrolled in the dalbavancin clinical development program as well as in vitro activity against methicillin-resistant Staphylococcus aureus (MRSA) and Neisseria gonorrhoeae were also presented.

"The data show that dalbavancin has the potential to be an efficacious and well-tolerated treatment option for patients with ABSSSI," said Durata Therapeutics Chief Medical Officer Michael Dunne, M.D. "Our studies were designed to meet the new standards required by regulatory authorities for antibiotic development in the United States and European Union and support our New Drug Application submission to the Food and Drug Administration late last week."

Dalbavancin is a novel antibacterial under investigation for the treatment of ABSSSI caused by susceptible Gram-positive microorganisms, such as S. aureus (including MRSA and other multi-drug resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. Dalbavancin is bactericidal against Gram-positive bacteria and is administered with a once-weekly dosage regimen of 1000 mg on Day 1 and 500 mg on Day 8, over 30 minutes by intravenous infusion.

Copies of the following posters will be available on Durata Therapeutics' website: http://www.duratatherapeutics.com.

Poster # 1339: An Integrated Analysis of the Efficacy of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the DISCOVER Programi (Date: October 5, 2013)

Data were presented from an integrated analysis of the efficacy results from the DISCOVER ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") program and found that dalbavancin is non-inferior to the comparator regimen at both an early timepoint and at the end of therapy. The DISCOVER program includes two Phase 3 identically designed multicenter, double-blind, randomized clinical trials of more than 1,300 adult patients with ABSSSI from the United States, Europe, Asia and South Africa. Patients were treated for two weeks either with intravenous dalbavancin once weekly (1000 mg on Day 1 followed by 500 mg on Day 8) or with intravenous vancomycin (1000 mg or 15 mg/kg every 12 hours) with the option to switch to oral linezolid after three days. Primary endpoints from the DISCOVER trials were cessation of spread of the erythema associated with the lesion and resolution of fever measured at 48-72 hours per FDA requirements. While a secondary endpoint for FDA, clinical success at end of treatment is the expected primary endpoint for regulatory review in Europe. Examining both endpoints provides clinicians with correlation between the early and late findings.

The integrated efficacy analysis found that:

Poster # 1340: Concordance of Clinical Response at 48-72 Hours after Initiation of Therapy and End of Treatment (EOT) in Patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in the DISCOVER Studiesii (Date: October 5, 2013)

An additional analysis of the DISCOVER clinical trials examined the concordance of study endpoints (i.e., clinical response at 48-72 hours after initiation of therapy as well as at the end of treatment) and found that the majority of early responders were ultimately cured. Specifically, the analysis found that:

"The early assessment timepoint recommended by the FDA was put in place to guide antibiotic drug development for ABSSSI," said Mark Wilcox, M.D., Head of Microbiology, Leeds Teaching Hospitals and Professor of Medical Microbiology at the University of Leeds, UK and an advisor to the DISCOVER clinical trial program. "These data, however, may also give physicians confidence at an early timepoint that could help identify patients who could ultimately be cured and those who might fail."

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Durata Therapeutics Presents New Comprehensive Review of the Efficacy and Safety Data of Dalbavancin and New In Vitro ...

In Vitro Diagnostics: World Market Outlook 2013-2023

NEW YORK, Sept. 30, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

In Vitro Diagnostics: World Market Outlook 2013-2023 http://www.reportlinker.com/p0578540/In-Vitro-Diagnostics-World-Market-Outlook-2013-2023.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

Report Details

In vitro diagnostic tests - your guide to trends and revenue prospects

What's the future of in vitro diagnostic (IVD) testing? Visiongain's updated report predicts those revenues to 2023. There you find the best places for sales growth, also understanding trends, technologies, and opportunities.

That study gives you revenue forecasts to 2023 at overall world market, submarket, and national level. See what's happening for those technologies, finding how you can gain.

Read on to explore that industry and see what its future market could be worth.

Forecasts 2013-2023 and other analyses to help you understand IVD potential

Besides revenue forecasting to 2023, our new work shows recent results, growth rates, and market shares. There you find original analysis. See technological developments too. You also get 52 tables, 40 charts, and two interviews. Many opportunities remain for those technologies and products. Now see how you can benefit your research, analyses, and decisions for IVD, also saving time. You hear what's happening there and see where the money lies. That way you reduce your risk of missing out. Finding data you need there just got easier. Try our new report.

The following sections show, then, how you benefit from our new investigation and analysis.

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In Vitro Diagnostics: World Market Outlook 2013-2023

ANSI Seeks Organizations to Take Part in International Standards Development Work on Microbiology

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ANSI Seeks Organizations to Take Part in International Standards Development Work on Microbiology New York September 30, 2013

All U.S. stakeholder organizations in relevant fields and industries are strongly encouraged to get involved and help influence the development of standards in this important field. Participants will have the opportunity to assist with the development of international standards on food-related microbiology that will have a significant impact on both food and animal feeds.

ISO TC 34/SC 9 is responsible for the development of International Standards on topics connected to food-related microbiology. The subcommittee is actively at work on standards, including recently approved efforts to begin development of standards on microbiological methods for the detection of Salmonella and Bacillus cereus emetic toxin in food and animal feeds, among other projects. The U.S. TAG to TC 34/SC 9 is responsible for advising ANSI on voting positions relevant to proposed and in-development standards, and carrying out detailed discussions related to these documents.

As the U.S. member body to ISO, ANSI accredits U.S. TAGs to develop and transmit U.S. positions on ISO technical activities. ANSI currently serves as the U.S. TAG Administrator to TC 34/SC 9, with financial and technical support from the U.S. Food and Drug Administration (FDA).

Organizations interested in joining the TAG or seeking to obtain additional information about TC 34/SC 9, the U.S. TAG, and related activities should email tc34sc9@ansi.org. Additional information will be provided to all those who notify ANSI that they are interested in participating on the U.S. TAG.

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ANSI Seeks Organizations to Take Part in International Standards Development Work on Microbiology

Vacuum dust: A previously unknown disease vector

Public release date: 30-Sep-2013 [ | E-mail | Share ]

Contact: Garth Hogan ghogan@asmusa.org 202-942-9389 American Society for Microbiology

The aerosolized dust created by vacuums contain bacteria and mold that "could lead to adverse effects in allergic people, infants, and people with compromised immunity," according to researchers at the University of Queensland and Laval University. Their findings are published ahead of print in Applied and Environmental Microbiology.

This finding is worrying as the study found resistance genes for five common antibiotics in the sampled bacteria along with the Clostridium botulinum toxin gene. This is of particular concern as, "The dust found indoors could act as a vehicle for infant botulism infection that can have severe consequences," including sudden infant death syndrome, according to previous studies.

"Even though no quantitative data are available for antibiotic resistance gene emission while vacuuming, the observed emission rates for bacteria might suggest that the genetic content of those bacterial cells, including antibiotic resistance genes, may contribute to indoor bioaerosol exposure," explain the researchers.

Researchers used a special clean air wind tunnel to measure vacuum emissions from 21 vacuums of varying quality and age. The clean air wind tunnel enabled them to eliminate other sources of particles and bacteria, says Knibbs. "That way, we could confidently attribute the things we measured purely to the vacuum cleaner."

The results were in accord with earlier studies which have shown human skin and hair to be important sources of bacteria in floor dust and indoor airwhich can be readily resuspended and inhaled, says report co-author, Caroline Duchaine.

Knibbs hopes that other studies will follow this one, raising the profile of potential indoor sources of culprits in unsolved medical cases. The investigators conclude their report, saying that vacuum cleaners are "underrepresented in indoor aerosol and bioaerosol assessment and should be considered, especially when assessing cases of allergy, asthma, or infectious diseases without known environmental reservoirs for the pathogenic or causative microbe."

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A copy of the manuscript can be found online at http://bit.ly/1dMhUfw. Formal publication is scheduled for the October 2013 issue of Applied and Environmental Microbiology.

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Vacuum dust: A previously unknown disease vector

Vibrio cholerae – “Colonel Cholera’s BASE cAMP” – SketchyMicro USMLE Microbiology Review – Video


Vibrio cholerae - "Colonel Cholera #39;s BASE cAMP" - SketchyMicro USMLE Microbiology Review
The Sketchy group is back...and we are up to no good! We have totally revamped our videos, and are planning to launch 44 bacteria videos on our website this ...

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Vibrio cholerae - "Colonel Cholera's BASE cAMP" - SketchyMicro USMLE Microbiology Review - Video