AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services.

We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

We have a global capacity for end-to-end protein biologics services offering mammalian and microbial production at our sites in Seattle, Chiba (Japan), Copenhagen (Denmark), Heidelberg (Germany), and a large-scale 20K stainless steel production facility in Boulder (Colorado), for optimized commercial manufacturing projects, at scale.

AGC Biologics also offers end-to-end cell and gene therapy development and manufacturing at our center of excellence in Milan, Italy. This location has produced five commercial products and is one of the most successful cell and gene sites in the industry. We can work with virtually any cell type and offer autologous and allogeneic processes for development and manufacturing. For viral vectors, we work in both suspension and adhesion and have large-scale manufacturing capacity to support projects of any size or stage. Our in-house pDNA can supply projects, and 95% of our tests are done in-house to shorten timelines as much as possible.

Type of Drugs Manufactured:

Biologics;Cell & Gene Therapy

CDMO Services:

Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Clinical Trials materials and logistics;Regulatory Services;Analytical Development

No. of Manufacturing Facilities:

6-10

Facilities Locations:

Europe;North America;East Asia

Regulatory Approvals:

FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan);Health Canada