CMO CMC Biologics And MacroGenics Partner On Oncology Product Candidates
By Cyndi Root
CMC Biologics announced in a press release that it has entered into a process validation and clinical manufacturing agreement with MacroGenics to commercialize MacroGenics’ oncology product candidates. CMC has expertise in advancing cell lines through development, early toxicology testing, and Phase I clinical trials. The collaboration will involve MacroGenics’ monoclonal antibody program that targets cancer.
Scott Koenig, MD, PhD, MacroGenics President and CEO, said, “Choosing a contract manufacturing partner with demonstrated process characterization and validation capabilities to meet our clinical and commercial timelines is critical to realizing the potential of breakthrough biologics and life-saving medicines.”
CMC and MacroGenics
The two companies agreed in May 2014 to develop a process to manufacture one of MacroGenics’ product candidates. Macrogenics develops monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. The new agreement is a Master Services Agreement that includes process validation activities and clinical manufacturing.
Recently, MacroGenics began a Phase I study of MGD006 in relapsed or refractory acute myeloid leukemia (AML). MGD006 is a bi-specific antibody-based molecule that binds to antigens expressed on leukemic cells and T lymphocytes. The study is evaluating the safety, tolerability, and activity of MGD006.
Additional CMC Partnerships
CMC announced a partnership with OncoSynergy in December 2013. The OncoSynergy project will be conducted at CMC’s manufacturing facility in Copenhagen, led by OncoSynergy France. Initially, the two will work on OncoSynergy’s OS2966 monoclonal antibody, a single drug that targets multiple cancers and cancer growth mechanisms.
About CMC Biologics
CMC Biologics has been manufacturing drugs for over 14 years. The company works with customers worldwide and has completed manufacturing projects for more than 60 pharmaceutical clients. The company provides pre-clinical studies through commercial production, including microbial manufacturing and perfusion manufacturing, among others.
CMC Biologics maintains facilities in Copenhagen, Denmark and Seattle, WA. The Copenhagen facility focuses on cell culture and microbial processing. Capabilities include cGMP cell banking, fermentation development labs, and solvent-based purification. The Seattle facility is capable of multiple cGMP manufacturing lines and single-use systems.