Its roles Owner Operator Developer
AGC Biologics S.p.A. is the Italian subsidiary of AGC Biologics, a global contract development and manufacturing organization (CDMO) owned by AGC Inc. The company serves biopharmaceutical developers by providing development and GMP manufacturing services for advanced therapies.
Based in the Milan area, AGC Biologics S.p.A. specializes in cell and gene therapy production, including lentiviral vector manufacturing and ex vivo genetically modified cell processing for clinical and commercial supply. Its capabilities include process and analytical development, technology transfer, scale-up, quality control, and regulatory support for U.S. and EU markets. The site operates within AGC Biologics’ international network across Europe, North America, and Asia.
Also known as AGC Biologics, AGC Biologics, Inc., and AGC Bio.
chemXplore tracks 1 project involving AGC Biologics S.p.A., of which one is active.
Process development and GMP manufacturing of lactoperoxidase and glucose oxidase to support an IND filing and a Phase II clinical trial in the US.
Yokohama technical center began cell therapy process development in July 2025 and has been awarded multiple exosome and T‑cell projects, including a program transferred from Milan.
Deal covers commercial manufacturing of multiple biopharmaceuticals using new Yokohama site; revenue expected at several tens of billions of yen; GMP services targeted for 2027.
Adds US sterile fill-finish, device assembly and packaging to create an integrated drug substance–drug product supply for clinical programs.
Microbial process development and GMP clinical manufacturing of rhMMP‑7 for intradiscal injection; cell bank moved from Heidelberg to Chiba; intended as a lumbar disc herniation treatment.
With Novelty Nobility, moves Copenhagen cell‑line/MCB work to GMP manufacturing in Chiba from May 2026. Targets retinal neovascular disease; global cGMP network enables tech transfer.
Waskyra™ gene therapy for Wiskott-Aldrich syndrome approved, offering a new treatment using patient cells, reducing donor dependency and rejection risk.
active all projects