Provider profile
AGC Biologics.
Biologics CDMOs · Part of AGC Inc.9
AGC Biologics describes process, cell line, analytical and formulation development and cGMP drug substance manufacturing of mammalian and microbial proteins, including monoclonal antibodies, plus mRNA, viral vectors and cell therapies, from Phase I to commercial supply. It lists headquarters in Bothell, WA and sites in Copenhagen, Heidelberg, Milan, Chiba and Yokohama, and states it is part of AGC Inc.
- Website
- agcbio.com (opens in a new tab)
- Sources reviewed
- November 3, 2026 · Source pages re-checked within 4 months
- First published
- November 3, 2026
This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.
Services and capabilities
Services and capabilities
- Analytical development and QC testing4,9
- Cell line development4
- Formulation development4
- GMP drug product manufacturing8In-house fill-finish stated for cell and gene therapy products; fill-finish for protein biologics, pDNA and mRNA is provided through partners BioConnection (EU) and Pyramid Pharma Services (US)
- GMP drug substance manufacturing1
- Lyophilization2Stated as lyophilized formulation and lyophilization cycle development; lyophilization fill-finish for protein biologics is provided through partner companies
- Process development9
- Stability studies2,4
- Technology transfer3
Development experience
Development experience
Locations
Locations
- Bothell, United States · Headquarters11Described as the Seattle global headquarters (Bothell, Washington)
- Copenhagen, Denmark · Manufacturing site9Listed for mammalian and microbial services
- Heidelberg, Germany · Manufacturing site10Microbial, pDNA and mRNA manufacturing
- Milan, Italy · Manufacturing site5Viral vector and cell therapy manufacturing
- Chiba, Japan · Manufacturing site9Listed for mammalian and microbial services
- Yokohama, Japan · Manufacturing site9New site; the homepage lists it as GMP-ready 2027 (mammalian, cell therapy and mRNA services)
- Bothell, United States · Manufacturing site9Listed for mammalian and microbial services
Quality and regulatory
Quality and regulatory
The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.
- GMP / cGMP5
Unknowns and questions to ask
Unknowns and questions to ask
Public sources rarely establish what matters most for a specific project. Confirm directly:
- Available capacity, slot timing and scale for your next campaign
- Recent experience with your specific modality and expression system or chemistry
- Regulatory inspection history of the specific site that would manufacture your product
- Technology-transfer approach, timeline and who owns the resulting process knowledge
- Analytical and QC release testing done in-house versus subcontracted
- Quality agreement terms, batch-failure responsibility and change-order mechanics
Evidence and sources
Evidence and sources
- 1Mammalian Manufacturing | Cell Culture Development | Biopharmaceutical (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 2C>/Biologics Analytical Development Services (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 3Biologics Process Development Cell & Gene Therapy Process Development (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 4Contract Development Manufacturing (CDMO) | Biologics and Cell & Gene Therapies: AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 5Bioprocess Manufacturing Biologics & ATMP CDMO services: AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 6Microbial Manufacturing Services | AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 7AGCellerate | DNA to IND Drug Substance Services | AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 8Fill & Finish Services for Drug Products at AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 9About Us | CDMO | AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 10Microbial, mRNA & pDNA Manufacturing | Heidelberg | AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
- 11Contact Us | AGC Biologics (opens in a new tab)AGC Biologics · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.
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Contact
Contact
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