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CMC Biologics To Manufacture IND Materials



By Kristin Brooks



Published December 17, 2013
Related Searches: Testing Phase I cGMP Development
CMC Biologics and OncoSynergy have entered an agreement for development and manufacture of material for early toxicology testing and cGMP material for IND toxicology studies and Phase I trials to advance OncoSynergy's OS2966 monoclonal antibody program.
 
The program is based on OncoSynergy's "Targeted Synergy" approach allowing broad inhibition of multiple fundamental cancer growth mechanisms with a single drug. OncoSynergy EU SAS in France will lead the project and CMC Biologics will provide cell-line development, process development, analytical development from its Copenhagen manufacturing facility. 
 
"We look forward to helping advance OncoSynergy's OS2966 drug platform targeting cancers resistant to currently available therapies," said Gustavo Mahler, global chief operations officer of CMC Biologics. "This contract highlights CMC Biologics' proven and trusted platform for monoclonal antibody development and manufacturing."
 
"We are impressed with CMC Biologics' experience and technical competency in biopharmaceutical development and cGMP manufacturing," said OncoSynergy co-founder and chief executive officer, Shawn Carbonell, M.D., Ph.D. "Choosing a partner who can provide a complete solution -- from expression of the sequence of interest to providing material suitable for clinical trials -- was a critical decision as we advance our lead candidate. They have also shown flexibility to accommodate our unique program needs as a virtual startup company."


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