AGC Biologics S.p.A.

Italyagcbio.com

Its roles Owner Operator Developer

project tracked
1
plant
1
partner companies
2
news articles
7

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.

Read more

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.

The project 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 Yokohama CDMO Manufacturing Facility
  1. Announced / Concept
  2. FEED / Pre-FID
  3. FID / Sanctioned
  4. Under Construction
  5. Commissioning & Start-up
Phase
Under Construction
Where
Japan
Partners
AGC , METI

AGC Biologics S.p.A. in chemical industry news

19 October 2026
AGC Biologics to develop and manufacture Flen Health enzyme therapy for diabetic foot ulcers

Process development and GMP manufacturing of lactoperoxidase and glucose oxidase to support an IND filing and a Phase II clinical trial in the US.

6 October 2026
AGC Biologics expands cell therapy development hub at Yokohama

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.

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

active all projects

  • Japan 1 active project, 1 in all