open access

Vol 52, No 4 (2021)
Review article
Published online: 2021-08-31
Submitted: 2021-07-07
Accepted: 2021-07-14
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Implementation of CAR-T technology into clinical practice: challenge for cell bank

Ewa Bembnista1
DOI: 10.5603/AHP.2021.0051
·
Acta Haematol Pol 2021;52(4):263-267.
Affiliations
  1. Stem Cell Bank, Department of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poznań, Poland

open access

Vol 52, No 4 (2021)
REVIEW ARTICLE
Published online: 2021-08-31
Submitted: 2021-07-07
Accepted: 2021-07-14

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).

Get Citation

Keywords

chimeric antigen receptor, CAR-T, advanced cellular therapy

About this article
Title

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

Journal

Acta Haematologica Polonica

Issue

Vol 52, No 4 (2021)

Article type

Review article

Pages

263-267

Published online

2021-08-31

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

References (6)
  1. Huang R, Li X, He Y, et al. Recent advances in CAR-T cell engineering. J Hematol Oncol. 2020; 13(1): 86.
  2. Dytfeld D, Łojko-Dankowska A, Matuszak M, et al. Road to clinical implementation of CAR-T technology in Poznań. Acta Haematol Pol. 2020; 51(1): 24–28.
  3. Ustawa z dnia 1 lipca 2005 r. o pobieraniu, przechowywaniu i przeszczepianiu komórek, tkanek i narządów. http://www.poltransplant.org.pl/ust_jednoli.html (1.06.2021).
  4. Dyrektywa Komisji 2006/86/WE z dnia 24 października 2006 r. wykonująca dyrektywę 2004/23/WE Parlamentu Europejskiego i Rady w zakresie wymagań dotyczących możliwości śledzenia, powiadamiania o poważnych i niepożądanych reakcjach i zdarzeniach oraz niektórych wymagań technicznych dotyczących kodowania, przetwarzania, konserwowania, przechowywania i dystrybucji tkanek i komórek ludzkich (Tekst mający znaczenie dla EOG). https://eur-lex.europa.eu/legal-content/PL/TXT/?uri=CELEX:32006L0086 (1.06.2021).
  5. Hornberger K, Yu G, McKenna D, et al. Cryopreservation of hematopoietic stem cells: emerging assays, cryoprotectant agents, and technology to improve outcomes. Transfus Med Hemother. 2019; 46(3): 188–196.
  6. Meneghel J, Kilbride P, Morris GJ. Cryopreservation as a key element in the successful delivery of cell-based therapies-a review. Front Med (Lausanne). 2020; 7: 592242.

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