FUJIFILM Biotechnologies
Technical leadership in cell culture, fermentation, and advanced therapies with world-class cGMP manufacturing.
Listed on cdmo.directory
CDMO partner offering end-to-end biologics development and manufacturing from pre-clinical through commercialization, with expertise in cell culture, microbial fermentation, cell and gene therapy, and cGMP manufacturing across US and European facilities. Headquartered in Cambridge, United States.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Biologics / bioreactor infrastructure
- Expression systems
- MammalianMicrobialViral VectorCell-Free
- Bioreactor type
- Single-Use / DisposableStainless Steel
Regulatory clearances
Services
- Cell-Line Development
- Process Development
- CMC Analytical Development
- Quality Control Testing
- Formulation Development
- Stability Testing & Storage
- CMC Regulatory Submission Support
- Upstream Processing
- Downstream Processing
- Microbial Fermentation
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- Vaccine Manufacturing
- Viral Vector Manufacturing
- Cell Therapy Manufacturing
- Technology Transfer
- Sterile Fill-Finish & Aseptic Manufacturing
About this organization
Overview
FUJIFILM Biotechnologies is a CDMO partner specializing in biologics, advanced therapies, and vaccines. The company combines technical leadership in cell culture, microbial fermentation, and cell and gene therapy with world-class cGMP manufacturing facilities.
Service Offerings
Pre-Clinical: Cell line and strain development, manufacturability assessments, cell banking, and toxicology material generation to support IND/IMPD submission.
Clinical Development: Process development and cGMP manufacturing support for Phase I, II, and Phase III clinical programs, including process optimization, scaling, and characterization.
Commercialization: Process validation, process performance qualification, CMC and regulatory services for BLA/MAA submissions.
Operational Philosophy
The company operates under KojoX™, a modular operational ecosystem designed to deliver speed and flexibility. This includes process modules for customer-specific recipes with fast tech transfers, equipment modules that are flexible yet standardized, and procedural modules ensuring high-quality cGxP execution.
Facilities
Production facilities located in the US and Europe support development and commercialization of treatments and therapies.
Recognition
Named a 2026 CDMO Leadership Award Winner, reflecting verified sponsor feedback and excellence in outsourcing performance for biologics innovation.
Locations
Headquarters
Cambridge · MA · USA
College Station
College Station · TX · USA
Holly Springs
Holly Springs · NC · USA
Research Triangle Park
Research Triangle Park · NC · USA
Thousand Oaks
Thousand Oaks · CA · USA
Billingham
Billingham · UK
Wilton
Wilton · UK
Hillerød
Hillerød · Denmark
Japan
US Facility
United States
United States
Headquarters
Commercial-scale manufacturing
Hillerød · Denmark
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