Dive Brief:
- AGC Biologics said last week it has inked a commercial supply deal with MacroGenics to manufacture the biotech's experimental cancer antibody margetuximab, currently in Phase 3 testing for metastatic breast cancer.
- A CDMO, AGC Biologics has provided development and validation services on margetuximab since 2014 and will begin to ready its operations for commercial supply.
- The company expects its late-stage study of margetuximab will complete enrollment in the fourth quarter, and read out data in the first half of 2019. The drug is also in testing for advanced gastric cancer.
Dive Insight:
Contract manufacture deals allow smaller biotechs, including those preparing to move toward market, to hand responsibility for drug production to service providers like AGC and focus on finishing clinical development.
Through the use of single-use bioreactors, companies like AGC can create smaller-volume manufacturing processes for biologics, and adapt to the needs of their biopharma partners. AGC has expanded its capacity recently, adding a 2,000 L single-use bioreactor at its Berkeley, California facility, and a new building complex at its Bothell, Washington site. The expansion in Bothell will include process development labs and corporate administrative offices, as well as more space for additional manufacturing capacity.
Other CMOs have expanded their single-use bioreactor capabilities of late as well, including Avid Bioservices in California, and WuXi Biologics in Ireland and China.
AGC Biologics was created in January 2018, following the integration of Asahi Glass Company Bioscience, Biomeva, and CMC Biologics. Earlier this month, it entered into an agreement with Horizon Pharma for commercial supply of the biopharma's teprotumumab, a monoclonal antibody biologic for the treatment of moderate-to-severe active thyroid eye disease.