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.

a Laboratory of Immunology, UMTCT, Rhône-Alpes French Blood Establishment, site of Grenoble, 29 avenue du maquis du Grésivaudan, 38701 La-Tronche, France

b R&D Laboratory, Rhône-Alpes French Blood Establishment, 38701 La-Tronche, France

c Apheresis Department, UMTCT, Rhône-Alpes French Blood Establishment, 38701 La-Tronche, France

d Quality Control Laboratory, UMTCT, CHU, 38700 Grenoble, France

e R&D Laboratory, UMTCT, Rhône-Alpes French Blood Establishment, 38701 La-Tronche, France

f Preperation Department, UMTCT, Rhône-Alpes French Blood Establishment, 38330 St Ismier, France

g Department of Hematology, CHU, 38700 Grenoble, France

h UMTCT, CHU, 38700 Grenoble, France

i Laboratory of Immunology, Rhône-Alpes French Blood Establishment, 38701 La-Tronche, France

j Laboratory of Immunology, CHU, 38700 Grenoble, France

Corresponding author. Tel.: +33-4-76-42-43-44; fax: +33-4-76-42-94-49

PII: S1473-0502(02)00101-5

doi:10.1016/S1473-0502(02)00101-5

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