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Overcoming Challenges in Process Development of Cellular Therapies.

作者信息

Highfill Steven L, Stroncek David F

机构信息

Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD, USA.

出版信息

Curr Hematol Malig Rep. 2019 Aug;14(4):269-277. doi: 10.1007/s11899-019-00529-5.


DOI:10.1007/s11899-019-00529-5
PMID:31278568
Abstract

PURPOSE OF THE REVIEW: Cellular therapy using chimeric antigen receptor (CAR) T cells as a treatment option for patients with lymphoma and leukemia has proven to be remarkably efficacious. This success has sparked the development of new cellular therapy products for numerous indications. Similar to pharmaceutical products, challenges exist at nearly every stage of process development; however, the unique nature of a cellular therapy product can present exceptional challenges that are just beginning to emerge. The purpose of this review is to explore some of the most common challenges experienced during the early phases of development of CAR T cell products and to provide suggestions for navigating these challenges. RECENT FINDINGS: Recent articles focused on CAR T cells are highlighted with special attention on aspects that relate to CAR T cell process development and clinical manufacturing. We examine the various stages of process development for CAR T cells and outline some of the obstacles that must be overcome in order to move from pre-clinical development into clinical manufacturing. As the field of CAR T cell therapy continues to grow, it is important to quickly move new CAR T cell products into and through early phase clinical trials and to ensure that the result of these trials can be adequately compared. Having laboratory and clinical investigators and GMP manufacturing facilities aligned on the numerous aspects of new product development will facilitate this process.

摘要

相似文献

[1]
Overcoming Challenges in Process Development of Cellular Therapies.

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引用本文的文献

[1]
A Sensitive and Controlled Data-Independent Acquisition Method for Proteomic Analysis of Cell Therapies.

J Proteome Res. 2022-5-6

[2]
Additional possibilities of chimeric antigen receptor T-cells in B-cell lymphoma: combination therapy.

Transl Cancer Res. 2020-11

[3]
Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control.

Hematol Transfus Cell Ther. 2021-11

[4]
Lymphocyte expansion in bioreactors: upgrading adoptive cell therapy.

J Biol Eng. 2021-4-13

[5]
Establishment of a cell processing laboratory to support hematopoietic stem cell transplantation and chimeric antigen receptor (CAR)-T cell therapy.

Transfus Apher Sci. 2021-2

[6]
Development of CAR-T cell therapy for B-ALL using a point-of-care approach.

Oncoimmunology. 2020

本文引用的文献

[1]
Effects of starting cellular material composition on chimeric antigen receptor T-cell expansion and characteristics.

Transfusion. 2019-4-11

[2]
Production of a cellular product consisting of monocytes stimulated with Sylatron (Peginterferon alfa-2b) and Actimmune (Interferon gamma-1b) for human use.

J Transl Med. 2019-3-14

[3]
PD-1-expressing B cells suppress CD4 and CD8 T cells via PD-1/PD-L1-dependent pathway.

Mol Immunol. 2019-3-6

[4]
The Emerging Role of In Vitro-Transcribed mRNA in Adoptive T Cell Immunotherapy.

Mol Ther. 2019-2-2

[5]
Clinical trials of dual-target CAR T cells, donor-derived CAR T cells, and universal CAR T cells for acute lymphoid leukemia.

J Hematol Oncol. 2019-2-14

[6]
Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions.

Mol Ther Methods Clin Dev. 2018-12-6

[7]
Characterization of clinical grade CD19 chimeric antigen receptor T cells produced using automated CliniMACS Prodigy system.

Drug Des Devel Ther. 2018-10-5

[8]
Induction of resistance to chimeric antigen receptor T cell therapy by transduction of a single leukemic B cell.

Nat Med. 2018-10-1

[9]
Purification of mRNA Encoding Chimeric Antigen Receptor Is Critical for Generation of a Robust T-Cell Response.

Hum Gene Ther. 2018-10-2

[10]
T Cells Genetically Modified to Express an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor Cause Remissions of Poor-Prognosis Relapsed Multiple Myeloma.

J Clin Oncol. 2018-5-29

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