End-To-End Clinical & Commercial Manufacturing Support For Biologics

Developing therapeutic biologics—whether monoclonal antibodies (mAbs), recombinant proteins, or other complex modalities—requires rigorous quality control, consistency, and regulatory compliance at every stage. As programs advance from early clinical trials to commercial manufacturing, the challenges intensify. Ensuring product integrity in large-scale bioreactors, adapting to evolving regulatory standards, and minimizing cross-contamination risks in multiproduct facilities are critical factors that can make or break a biologic’s success.

At Abzena, we have built our Clinical & Commercial Manufacturing capabilities specifically to address these challenges. Our dedicated cGMP facility in San Diego, CA, is equipped to produce high-quality recombinant proteins and antibodies at scales up to 2000 L, featuring single-use bioreactors and two independent production lines to protect product quality. By combining deep scientific expertise, a comprehensive Quality Management System (QMS), and adaptable capacity, Abzena delivers the integrated support needed to smoothly transition from clinical-scale batches to full commercial production.