CMC Biologics and MacroGenics Enter Manufacturing Agreement

By Pharmaceutical Manufacturing Staff

May 08, 2014

CMC Biologics Inc. and MacroGenics Inc. recently announced an agreement to further develop the production process for transfer and clinical manufacturing of MacroGenics' lead oncology product candidate, margetuximab, a Phase II monoclonal antibody developed to treat HER2-positive breast cancer.

Last October the financial community rewarded MacroGenics with an $80-million IPO in a peak wave of venture capital that birthed nearly 40 biotech IPOs and generated more than $2.7 billion in gross proceeds according to Seeking Alpha, analyst Tim Keating who noted that figure exceeds the total amount raised by the biotech sector in the previous five years.

MacroGenics president and CEO Scott Koenig, lauded the deal offering "We are impressed with CMC Biologics' experience and technical competency in biopharmaceutical development and cGMP manufacturing. Choosing a contract manufacturing partner with quality facilities that is able to provide flexible solutions and meet our clinical timelines is critical to realizing the potential of life-saving medicines."

Similarly pleased with the collaboration, CMC Biologics chief operations officer Gustavo Mahler noted "This contract highlights CMC Biologics' focus on working with our customers as partners and our capabilities in the development and clinical manufacturing of monoclonal antibodies."

CMC Biologics operates three facilities in the U.S. and Europe, offering, according to the company “fully integrated biopharmaceutical development and manufacturing solutions to clients globally.” Known for delivering scale-up and cGMP-based manufacturing solutions for the pre-clinical, clinical trial and commercial production of protein-based therapeutics, the company's services include cell line development, bioprocess development, formulation and comprehensive analytical testing. CMC Biologics' also offers its proprietary CHEF1® expression system for mammalian production.