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

Citation
S. Bercegeay et al., Conception and organisation of a cell therapy unit of Nantes, France, HEM CELL TH, 41(5), 1999, pp. 223-228
Citations number
7
Categorie Soggetti
Hematology,"Cardiovascular & Hematology Research
Journal title
HEMATOLOGY AND CELL THERAPY
ISSN journal
12693286 → ACNP
Volume
41
Issue
5
Year of publication
1999
Pages
223 - 228
Database
ISI
SICI code
1269-3286(199911)41:5<223:CAOOAC>2.0.ZU;2-#
Abstract
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.