PLANTATION, Fla. and HOUSTON, June 4, 2012 /PRNewswire/ --Goodwin Biotechnology, Inc. (GBI) and The University of Texas MD Anderson Cancer Center jointly announce a collaboration for process development and GMP manufacturing of a fusion protein composed of a vascular endothelial growth factor (VEGF) and the recombinant toxin, Gelonin (rGel), conjugated to a DOTA chelator. The fusion protein targets the tumor neovasculature, or blood supply, and inhibits tumor growth, and the DOTA chelator facilitates the subsequent labeling with a radioisotope for diagnostic imaging and/or therapeutics.
GBI has completed process development and is readying for the GMP manufacture of the drug conjugate. The GMP manufactured drug conjugate will subsequently be radiolabeled with 64Cu and evaluated in an early stage, human clinical trial.
"Contributing to such a medical advance is exciting," noted Muctarr Sesay, PhD, Vice President of Process Development at GBI. "We have a long history of collaborating with Dr. Rosenblum and MD Anderson for GMP manufacturing of therapeutic antibody : drug conjugates that have been used in human clinical trials. With the current project, we are also leveraging our extensive experience with preparing conjugates for subsequent radioisotope labeling to develop this important product for diagnostic and therapeutic applications."
"I have worked with GBI for over 10 years producing antibody : drug conjugates, and have been impressed with their bioconjugation expertise and the service they provide," noted Michael G. Rosenblum, Ph.D. Professor of Medicine; Head, Immunopharmacology and Targeted Therapy Laboratory and Director of Research Development in the Department of Experimental Therapeutics at MD Anderson. "The conjugate we are developing will hopefully enhance our ability to detect and treat primary cancers sooner, but it may also more accurately identify and inhibit metastatic spread earlier in the course of the disease."
About Goodwin Biotechnology, Inc. Goodwin Biotechnology is a fully integrated cGMP contract manufacturer of monoclonal antibodies, recombinant proteins and vaccines. GBI has the expertise and experience in cell line development, process development and GMP manufacturing of recombinant proteins and antibodies, as well as conjugated therapeutic proteins (e.g., antibodies conjugated to linkers for radioimmune therapy and diagnostics, other antibodies, proteins, chemotoxins, or plant toxins) by leveraging our proprietary conjugation technology. By working with GBI, our clients can enhance the value of their product candidates with clear development and manufacturing strategies and a road map to meet product requirements from the milligram, gram and kilogram range as the product candidates move along the clinical approval pathway. With nearly 20 years of experience as an independent contract manufacturer, GBI has worked with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established biopharmaceutical companies. For more information, please visit http://www.goodwinbio.com/.
For more information on the University of Texas M.D. Anderson Cancer Center, please visit http://www.mdanderson.org/
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Goodwin Biotechnology and MD Anderson Cancer Center Collaborate on the GMP Manufacturing of a Fusion Protein Conjugate ...