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Prérequis pour une production académique des cellules CART conforme aux bonnes pratiques pharmaceutiques (BPF). Recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC)

Published inBulletin du cancer, vol. 107, no. 1S, p. S85-S93
Publication date2020
Abstract

The extraordinary and unexpected success of cellular immunotherapy using genetically engineered T-cells to express a chimeric antigen receptor (CAR) targeting CD19, in the treatment of refractory or relapsing B-hematological malignancies, has provided a real therapeutic hope. Indeed, remission rates reach more than 80 % in patients at a stage, without any other possibilities of treatment, notably in the child's acute lymphoblastic leukemia. These results, initially resulting from academic research, led to Food and Drug accreditation for market access of two innovative autologous therapy drugs, Kimryah® and Yescarta®. Based on the impressive clinical results, mainly so far in hematological malignancies (LAL, MM, LBDGC, etc.), the development of several types of cells expressing a CAR receptor suggests a wide range of future applications, particularly in the field of solid tumors. However, while the development of CAR-T cells now appears to be in the hands of private pharmaceuticals companies, the logistical constraints, the cryopreservation and the very high cost of these personalized medicines may ultimately limit their use. The development of academic productions by CAR-T cells could bypass some of these disadvantages. The strong innovation capacity of healthcare institutions associated with research units allows them to identify the ideal tumor target and efficient performing cells. Thus, authorized production platforms could allow for shorter administration times and reasonable production costs for national health systems. The aim of this workshop is to identify the requirements for the academic production of CAR-T cells, while respecting the research standards useful to establish proof of concept, but also at the preclinical development stage, leading in fine to the manufacture, through an authorized pharmaceutical establishment, of the innovative therapy drug, and in accordance with Good Manufacturing Practice (GMP). The ultimate goal is to make these innovative and high-performance medicines available to as many patients as possible.

Keywords
  • Academic Medical Centers
  • Antibodies, Monoclonal/genetics/immunology
  • Antigens, Neoplasm/immunology
  • Cell Culture Techniques
  • Cell Line
  • Drug Industry
  • Europe
  • France
  • Genetic Vectors/genetics
  • Humans
  • Immunotherapy, Adoptive/economics/methods/standards
  • Lentivirus/genetics
  • Recombinant Fusion Proteins/genetics/immunology
  • T-Cell Antigen Receptor Specificity
  • Transgenes
  • Academic research
  • Chimeric Antigen Receptor
  • Immunotherapy
  • Immunothérapie
  • Recherche académique
  • Récepteur chimérique à l'antigène
Citation (ISO format)
DESCHAMPS, Marina et al. Prérequis pour une production académique des cellules CART conforme aux bonnes pratiques pharmaceutiques (BPF). Recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC). In: Bulletin du cancer, 2020, vol. 107, n° 1S, p. S85–S93. doi: 10.1016/j.bulcan.2019.08.006
Main files (2)
Article (Published version)
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Article (Accepted version)
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Identifiers
Journal ISSN0007-4551
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65downloads

Technical informations

Creation28/10/2020 14:07:00
First validation28/10/2020 14:07:00
Update time16/03/2023 01:18:09
Status update16/03/2023 01:18:08
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