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Just - Evotec Biologics to design a manufacturing process for the production of Phase I cGMP clinical supply of a broadly neutralizing antibody against HIV.
June 9, 2020
By: Contract Pharma
Contract Pharma Staff
Evotec SE’s subsidiary Just – Evotec Biologics, Inc. has entered into an agreement with Advanced BioScience Laboratories, Inc. (ABL), a global CDMO to the U.S. Government and biopharmaceutical industry. This project has been funded with Federal funds under a $318.5 million contract from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services. Under the agreement, Just – Evotec Biologics will design an efficient manufacturing process required for the production of Phase I cGMP clinical supply of a broadly neutralizing antibody against HIV. Just – Evotec Biologics will support ABL by designing scalable development processes capable of producing a suitably scaled production run under cGMP conditions acceptable for human clinical trials. Just – Evotec Biologics will also design a product formulation suitable for clinical infusion and provide assay development and release and stability testing services. Andrew Arrage, Senior Vice President, Business Development at ABL, said, “We value our partnership with Just – Evotec Biologics as our subcontractor for the development of this critical product. ABL’s collaborative partnering approach coupled with Just – Evotec Biologics’ development capabilities will enable the delivery of clinical materials by the end of 2020.” Dr. Craig Johnstone, Chief Operating Officer of Evotec, said, “Through the use of Just – Evotec Biologics’ technology platform, we are extremely pleased to be supporting ABL to advance this important antibody molecule targeting HIV. Our experience with bnAbs continues to inform our efforts towards the compelling goal of rapidly developing highly efficient production processes resulting in affordable biologics for broader patient access globally.”
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