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Quality control for the validation of extracorporeal photopheresis process using the Vilbert-Lourmat UV-A
Marie-Christine Jacob1, Olivier Manches, Philippe Drillat
1Laboratory 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
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.
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