Manufacturing of cell therapy products has to follow several requirements t
o obtain sanitary security and quality of the product. Thus, at its concept
ion, the cell therapy unit (CTU) of Nantes choose to integrate a quality as
surance 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 pr
oducts in term of staff, premises, material, matter and method;
The ISO 9001 standards are a model for quality assurance in design, develop
ment, production, installation and servicing. They etablished a quality sys
tem;
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 Tune 1998, 450 cell processing (with or without
cryopreservation and storage of cells) have been realised at the CTU of Nan
tes, leading to 160 injections without major undesirable effect and without
microbiological contamination.