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Implementation of CAR-T technology into clinical practice: challenge for cell bank
Affiliations- Stem Cell Bank, Department of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poznań, Poland
open access
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).
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).
Keywords
chimeric antigen receptor, CAR-T, advanced cellular therapy
About this articleTitle
Implementation of CAR-T technology into clinical practice: challenge for cell bank
Journal
Issue
Article type
Review article
Pages
263-267
Published online
2021-08-31
Page views
202
Article views/downloads
276
DOI
10.5603/AHP.2021.0051
Bibliographic record
Acta Haematol Pol 2021;52(4):263-267.
Keywords
chimeric antigen receptor
CAR-T
advanced cellular therapy
Authors
Ewa Bembnista
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