Optimization - Development Specificities

The Cell and Gene Therapy Unit (Unité de Thérapie Cellulaire et Génique - UTCG) also offers customized R&D services either specific (contract research projects) or for manufacturing improvements (optimization).

Development :

• cell types and models, manufacturing devices design
• methodology and control assessments
• manufacture adaptation : processes and safety, stability studies, scale up processes, ancillary reagents clinical grade validation, quality controls
• secured cell banks

Optimization : improvement of manufacturing processes and controls in terms of efficacy, outputs, easiness, safety, ancillary reagents replacement when necessary…

The area includes two culture rooms and a storage room over 50 square meters.

In terms of regulatory service, UTCG offers its assistance and advice to its customer to create and write the submission files to health authorities.