AGC Biologics S.p.A.

Italyagcbio.com

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.

Projects AGC Biologics S.p.A. is involved in

chemXplore tracks 1 project involving AGC Biologics S.p.A., of which one is active.

AGC Biologics S.p.A.'s role on them: Owner, Operator, and Developer.

1 Under Construction

1 new construction.

Expected to start operating
2026
none
2027
1 project
2028
none
2029
none
2030
none
2031
none

Licensors are recorded on this project For subscribers

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Latest news on AGC Biologics S.p.A.

28 July 2026
AGC Biologics secures long-term manufacturing partnership with leading global biopharma

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.

2 July 2026
AGC Biologics partners with Pyramid Pharma Services to add US drug-product manufacturing

Adds US sterile fill-finish, device assembly and packaging to create an integrated drug substance–drug product supply for clinical programs.

8 June 2026
AGC Biologics to develop and manufacture KTP-001 (rhMMP-7) for Teikoku Pharma

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.

26 May 2026
AGC Biologics Starts NN4101 Bispecific Antibody Development and GMP Production

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.

19 January 2026
AGC Biologics Gains U.S. and EU Approval for Waskyra™ Gene Therapy

Waskyra™ gene therapy for Wiskott-Aldrich syndrome approved, offering a new treatment using patient cells, reducing donor dependency and rejection risk.

Where its projects are

By country, the most active first. active / all projects

  • Japan 1 active project, 1 in all