title: Quality control for the validation of extracorporeal photopheresis process using the Vilbert-Lourmat UV-A irradiation's system.
abstract: In agreement with good practices for therapeutic use of human cells, quality control has to be performed to valid the process of extracorporeal photopheresis (ECP) with the Vilbert-Lourmat system. Since no protocol exists, we evaluated a technique based on the measurement of the inhibition of mitogen (PHA, Con-A, OKT3)-induced proliferation, in 164 procedures from 16 patients. Whatever the pathology, we observed a high proliferation rate in most samples, and we obtained over 90% ECP-induced inhibition in as many as 94% of the cases. Since this approach proved to be relevant regarding our objective, a protocol for the ECP process validation is proposed.
authors.affiliation: Laboratory of Immunology, UMTCT, Rhône-Alpes French Blood Establishment, site of Grenoble, 29 avenue du maquis du Grésivaudan, 38701 La-Tronche, France. marie-christine.jacob@efs.sante.fr
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Jacob
authors.forename: Olivier
authors.initials: O
authors.lastname: Manches
authors.forename: Philippe
authors.initials: P
authors.lastname: Drillat
authors.forename: Marie-Jeanne
authors.initials: MJ
authors.lastname: Richard
authors.forename: Joël
authors.initials: J
authors.lastname: Plumas
authors.forename: Laurence
authors.initials: L
authors.lastname: Chaperot
authors.forename: Harald
authors.initials: H
authors.lastname: Hegelhofer
authors.forename: Frédéric
authors.initials: F
authors.lastname: Garban
authors.forename: Rémy
authors.initials: R
authors.lastname: Gressin
authors.forename: Marie
authors.initials: M
authors.lastname: Favrot
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Bensa
authors.forename: Martine
authors.initials: M
authors.lastname: Pernollet
mesh_terms: D002455:Cell Division / Q000187:drug effects / Q000528:radiation effects; D019544:Equipment Failure Analysis / Q000379:methods; D006801:Humans; D015458:Leukemia, T-Cell / Q000473:pathology / Q000628:therapy; D007963:Leukocytes, Mononuclear / Q000473:pathology; D016399:Lymphoma, T-Cell / Q000473:pathology / Q000628:therapy; D008934:Mitogens / Q000494:pharmacology; D017893:Photopheresis / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D011786:Quality Control; D013936:Thymidine / Q000378:metabolism
chemical_list: D008934:Mitogens; D013936:Thymidine