End-to-End Clinical & Commercial Manufacturing Support for Biologics

Scaling a monoclonal antibody, recombinant protein, or other complex biologic from early-phase studies to commercial supply takes more than a bigger bioreactor—it demands proven process control, rigorous cGMP oversight, and facilities engineered to prevent cross-contamination in a multiproduct setting.

Abzena’s Clinical & Commercial Manufacturing facility in San Diego, CA was purpose-built to meet those demands. Two segregated, single-use production trains (up to 2 000 L) operate within ISO Class 7/8 cleanrooms and ISO Class 5 biosafety cabinets, eliminating cleaning validation, shortening change-overs, and protecting product integrity. Our robust Quality Management System links raw-material control, in-process monitoring, and full GMP documentation to global regulatory standards, ensuring every batch is release-ready.

From master cell-bank thaw through bulk drug-substance fill, integrated upstream and downstream operations—and on-site analytics and bioassay support—provide a seamless, de-risked path from clinical supply to commercial campaigns. Flexible scheduling lets sponsors run parallel programs or scale up without engineering re-runs, keeping timelines on track while maintaining unwavering quality.

Download the Clinical & Commercial Manufacturing for Biologics info sheet