cGMP Biologics Clinical Manufacturing

At Abzena, quality control and stability testing are central to every stage of clinical biologics manufacturing. Our Quality organization ensures the delivery of safe, compliant products that meet global regulatory expectations and protect patient safety.

We maintain a comprehensive quality management system that supports every clinical manufacturing facility within our network. This system ensures full alignment with regulatory requirements and cGMP manufacturing standards.

Beyond compliance, Abzena’s technical and analytical expertise enables us to support a wide range of biologic and cell therapy modalities, from simple constructs to complex, multi-functional molecules.

Our modern, single-use facility located in San Diego, CA, deploys the latest in technology and processing, including high titer processing, continuous manufacturing, and perfusion.

Our upstream facilities include single-use bioreactors ranging from 50L to 2,000L. Our downstream process capabilities include chromatography ranging up to 80cm columns.

We offer comprehensive analytical support using industry-leading analytical platforms such as LC-MS (Orbitrap, QTOF, MALDI-TOF, QQQ, and Q), biolayer interferometry, (u)HPLC, CE, iCIEF, and SoloVPE. These tools ensure product integrity, stability, and regulatory compliance across all stages of development.

• Scalable Manufacturing Campaigns: With two manufacturing trains, we can simultaneously produce material at di erent scales—supporting multiple clinical programs or enabling a commercial campaign in parallel with earlier-stage development batches.
• Regulatory & Analytical Support: Abzena’s analytical and bioassay teams are integrated into every manufacturing campaign, ensuring real-time data on critical quality attributes (CQAs). This holistic support helps sponsors navigate IND/BLA submissions and maintain compliance throughout commercialization.

By combining a purpose-built cGMP facility, single-use disposable platforms, and rigorously validated processes, Abzena delivers a clear, scalable, and compliant pathway from cell bank to bulk drug substance. Our end-to-end solution is structured to minimize risk, maximize quality, and help you successfully advance your biologic through clinical development and into the commercial market.