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Provider profile

FUJIFILM Biotechnologies.

Biologics CDMOs

FUJIFILM Biotechnologies documents cell line, process, analytical and formulation development and cGMP drug substance and aseptic drug product manufacturing using mammalian (CHO) and microbial systems, plus viral vector and cell therapy manufacturing, from Phase I to commercial supply. It lists manufacturing sites in North Carolina, Texas and California (US), Hillerød (Denmark) and Teesside (UK).

Website
fujifilmbiotechnologies.fujifilm.com (opens in a new tab)
Sources reviewed
November 4, 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
  • Cell line development1
  • Formulation development13
  • GMP drug product manufacturing6Vials, pre-filled syringes and cartridges; drug product network listed as Thousand Oaks, Holly Springs, College Station and Hillerød
  • GMP drug substance manufacturing14Stated for Holly Springs, NC
  • Highly potent APIs2Stated as dedicated suites for high potency biologics within microbial cGMP manufacturing
  • Process development1,2,3Includes mammalian, microbial and viral vector process development
  • Stability studies5,6Excerpt stated for viral vector programs; drug product page states stability studies across the network

Platforms and methods

  • Mammalian cell culture1
  • Microbial fermentation2
  • Single-use bioreactors7,8

Drug substance / drug product

  • Drug product6
  • Drug substance14

Development experience

Development experience

Development stage

  • Commercial5,8Stated for viral vector capacity and large-scale (20,000 L) mammalian manufacturing
  • Phase 116
  • Phase 316
  • Preclinical9Optional material supply run for preclinical work (mammalian platform)

Modality

  • Cell therapies15Stated for the Thousand Oaks, CA facility
  • Gene therapies5Viral vector manufacturing; viral vector facilities listed as College Station, TX and Billingham, UK
  • Monoclonal antibodies1,10
  • Recombinant proteins1,11
  • Vaccines5,12Stated as viral vectors for vaccines

Locations

Locations

  • Hillerød, Denmark · Manufacturing site17,20Site expansion stated as completing in 2026
  • Tokyo, Japan · Office17Sales and customer support office
  • Billingham, United Kingdom · Manufacturing site17,21Process development and microbial centre; home to a single-use CDMO facility
  • Darlington, United Kingdom · Manufacturing site22Viral and gene therapy facility; no dedicated site page
  • Wilton, United Kingdom · Manufacturing site22Viral and gene therapy facility
  • Cambridge, United States · Office23Office and collaboration center at One Kendall Square, Cambridge, MA; not a manufacturing site
  • College Station, United States · Manufacturing site17,19Listed as a viral vector CDMO facility and in the drug product and finished goods network
  • Holly Springs, United States · Manufacturing site14,17Large-scale mammalian cell culture drug substance (8 x 20,000 L) with co-located drug product
  • Morrisville, United States · Manufacturing site17,18Research Triangle Park site: non-sterile drug substance facility with bulk fill
  • Thousand Oaks, United States · Manufacturing site15,17Cell therapy manufacturing site

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 / cGMP2,4

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

Choosing a CDMO: a practical guide

Evidence and sources

Evidence and sources

  1. 1ApolloX™ Cell Line Development | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2cGMP Production of Microbial Drug Substance (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3Process and Analytical Development for Cell & Gene Therapies | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Analytical Service GMP | Analytical Services | FUJIFILM (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5GMP Manufacturing for Cell and Gene Therapies | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  6. 6Drug Product CDMO | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  7. 7Continuous Manufacturing Process | MaruX | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  8. 8cGMP Mammalian Drug Substance Manufacturing | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  9. 9Biologics Manufacturability Assessment | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  10. 10Mammalian Process Development | FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  11. 11Paveway™ PLUS Microbial Expression Platform | Microbial Strain Development (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  12. 12Your CDMO Partner FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  13. 13Formulation Development and Optimization (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  14. 14Global Facilities – Holly Springs, NC (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  15. 15Global Facilities – Thousand Oaks, CA (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  16. 16FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  17. 17Contact Us - FUJIFILM Biotechnologies (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  18. 18Global Facilities – Research Triangle Park, NC (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  19. 19Global Facilities – College Station, TX (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  20. 20Global Facilities – Hillerød, Denmark (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  21. 21Global Facilities – Billingham, UK (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  22. 22Global Facilities – Wilton, United Kingdom (opens in a new tab)FUJIFILM Biotechnologies · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  23. 23Global Facilities – Cambridge, MA (opens in a new tab)FUJIFILM Biotechnologies · 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

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