AGC Biologics

AGC Biologics is a global contract development and manufacturing organization (CDMO/CMO) specializing in biologics development and manufacturing. The company offers comprehensive services across multiple modalities including protein expression biologics, plasmid DNA (pDNA), mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells.

Manufacturing Capabilities

The organization employs scale-out manufacturing strategies using modular, single-use bioreactor systems to expand capacity in parallel, reducing regulatory complexity and accelerating time to market. This approach maintains consistent vessel size from early-stage production through commercial manufacturing, avoiding parameter changes that accompany traditional scale-up and reducing comparability risk.

AGC Biologics operates facilities including a multi-purpose Yokohama facility in Japan providing full cell therapy, mammalian, and mRNA services. The company supports technology transfer across global sites through standardized equipment configurations, aligned quality systems, and consistent single-use processes.

Process Flexibility

The company's scale-out model enables efficient technology transfer between manufacturing sites and provides operational flexibility for programs navigating accelerated regulatory pathways. Capacity can be expanded by running additional parallel batches if demand exceeds projections or additional indications are approved.