Implementation of CAR-T technology into clinical practice: challenge for cell bank

Abstract

This publication is based on experience gained during the accreditation and certification process of the first Polish center (Department of Hematology and Bone Marrow Transplantation in Poznan University of Medical Sciences) to perform the procedure of treating a patient with chimeric antigen receptor T therapy. It focuses on the functioning of the quality assurance system in the cell bank both on a general and a detailed level, concerning in particular the processing of the autologous lymphocyte product by the cell bank, i.e. its preparation for further processing steps by the manufacturer of the marketing authorization: advanced therapy medicinal product/advanced therapy investigational medicinal product (MA-ATMP/ATIMP). It also provides practical guidelines to help other cell banks to successfully meet national requirements expressed by the accreditation of the Ministry of Health for the processing and release for circulation of autologous lymphocyte product and the certification pathway of the MA-ATMP/ATIMP manufacturer (companies: Kite/Gilead, Novartis and Janssen).