Conception and organisation of a cell therapy unit of Nantes, France.

Abstract

Manufacturing of cell therapy products has to follow several requirements to obtain sanitary security and quality of the product. Thus, at its conception, the cell therapy unit (CTU) of Nantes choose to integrate a quality assurance system: - The good manufacturing practices (GMP's) are a technical reference for the Unit. They are a quality criteria necessary to guarantee the security of products in term of staff, premises, material, matter and method; - The ISO 9001 standards are a model for quality assurance in design, development, production, installation and servicing. They established a quality system; - The creation, the running and the maintenance of premises are an essential aspect of the quality system and they are described in this paper. Thus, from October 1994 to June 1998, 450 cell processing (with or without cryopreservation and storage of cells) have been realised at the CTU of Nantes, leading to 160 injections without major undesirable effect and without microbiological contamination.