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Platforms for Clinical-Grade CAR-T Cell Expansion

  • Amanda MizukamiEmail author
  • Kamilla Swiech
Protocol
Part of the Methods in Molecular Biology book series (MIMB, volume 2086)

Abstract

Chimeric antigen receptor (CAR)-T cell therapy has revolutionized the immunotherapy field with high rate complete responses especially for hematological diseases. Despite the diversity of tumor specific-antigens, the manufacturing process is consistent and involves multiple steps, including selection of T cells, activation, genetic modification, and in vitro expansion. Among these complex manufacturing phases, the choice of culture system to generate a high number of functional cells needs to be evaluated and optimized. Flasks, bags, and rocking motion bioreactor are the most used platforms for CAR-T cell expansion in the current clinical trials but are far from being standardized. New processing options are available and a systematic effort seeking automation, standardization and the increase of production scale, would certainly help to bring the costs down and ultimately democratize this personalized therapy. In this review, we describe different cell expansion platforms available as well as the quality control requirements for clinical-grade production.

Key words

Chimeric antigen receptor CAR-T cells Manufacturing Culture systems Bioreactors Quality control 

Notes

Acknowledgments

This work was financially supported by FAPESP (2016/19741-9), CTC Center for Cell-based Therapies (FAPESP 2013/08135-2) and National Institute of Science and Technology in Stem Cell and Cell Therapy (CNPq 573754-2008-0 and FAPESP 2008/578773). The authors also acknowledge financial support from Secretaria Executiva do Ministério da Saúde (SE/MS), Departamento de Economia da Saúde, Investimentos e Desenvolvimento (DESID/SE), Programa Nacional de Apoio à Atenção Oncológica (PRONON) Process 25000.189625/2016-16.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2020

Authors and Affiliations

  1. 1.Center for Cell-Based Therapy CTC, Regional Blood Center of Ribeirão PretoUniversity of São PauloSão PauloBrazil
  2. 2.School of Pharmaceutical Sciences of Ribeirão PretoUniversity of São PauloRibeirão Preto, São PauloBrazil

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