An AAV Platform Advancing Successful Viral Vector Based Therapeutics - FUJIFILM Biotechnologies

FUJIFILM Biotechnologies is a CDMO partner specializing in biologics, advanced therapies, and vaccines. The organization provides end-to-end support across the development lifecycle:

Development & Manufacturing Services:

• Pre-clinical: cell line and strain development, manufacturability assessments, cell banking, and toxicology material generation to support IND/IMPD submission
• Clinical Phase I & II: development of initial clinical cGMP drug substance and drug product manufacturing processes
• Clinical Phase III: process optimization, scaling, and characterization to meet therapeutic demands
• Commercialization: process validation, process performance qualification, CMC and regulatory services for BLA/MAA submission

Technical Capabilities: The company combines technical leadership in cell culture, microbial fermentation, and cell and gene therapy with world-class cGMP manufacturing facilities. Operations leverage the KojoX operational ecosystem—a modular approach featuring process modules for customer-specific recipes, equipment modules for flexible standardized configurations, and procedural modules ensuring high-quality cGxP execution.

Facilities & Infrastructure: Production facilities located in the US and Europe support development and commercialization of treatments and therapies. Recent expansion includes a new laboratory doubling quality control footprint at the Hillerød commercial-scale manufacturing site.

Recognition: Named a 2026 CDMO Leadership Award Winner, reflecting verified sponsor feedback and excellence in outsourcing performance for biologics innovation.