Quality control for the validation of extracorporeal photopheresis process using the Vilbert-Lourmat UV-A irradiation's system.
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.
Jacob
Marie-Christine
MC
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
Manches
Olivier
O
Drillat
Philippe
P
Richard
Marie-Jeanne
MJ
Plumas
Joël
J
Chaperot
Laurence
L
Hegelhofer
Harald
H
Garban
Frédéric
F
Gressin
Rémy
R
Favrot
Marie
M
Bensa
Jean-Claude
JC
Pernollet
Martine
M
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
D008934:Mitogens; D013936:Thymidine