CART manufacturing process and reasons for academy-pharma collaboration

•CAR technology is more than a promising immunotherapy; it is a reality.•Number of clinical trials testing academic and industry CARs are increasing.•Improvements in m process are being continuously implemented.•Regulatory obstacles condition the progress and clinical expansion of this therapy.•The...

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Bibliographic Details
Published in:	Immunology letters Vol. 217; pp. 39 - 48
Main Authors:	Egri, Natalia, Ortiz de Landazuri, Iñaki, San Bartolomé, Clara, Ortega, J. Ramón, Español-Rego, Marta, Juan, Manel
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-01-2020
Subjects:	Adoptive cell immunotherapy CART Chimeric antigen receptor Good manufacturing practice RCR ALL FDA LVL Good manufacturing practice CRS VSVG CART19 BCMA TSCM QA DLCL QC NHL TRUCKs TEff Adoptive cell immunotherapy TAAs EGFRvIII GPC3 EMA CD3ζ CARTs CEA iNKT FcRγ MM GvHD GMP PBMCs Chimeric antigen receptor ACITs CAR scFv tTCR TN RCL TILs HER2 PBLs TEM TCM CART
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Summary:	•CAR technology is more than a promising immunotherapy; it is a reality.•Number of clinical trials testing academic and industry CARs are increasing.•Improvements in m process are being continuously implemented.•Regulatory obstacles condition the progress and clinical expansion of this therapy.•The cohabitation of academic and industry CARs is challenging, but necessary. The success of genetically engineered T-cells modified with a chimeric antigen receptor as an adoptive cell immunotherapy and the subsequent last regulatory approvals of products based on this therapy are leading to a crescent number of both academic and pharmaceutical industry clinical trials testing new approaches of this “living drugs”. The aim of this review is to outline the latest developments and regulatory considerations in this field, with a particular emphasis to differences and similarities between academic and industry approaches and the role they should play to coexist and move forward together. To do that, the main considerations for the manufacturing process are firstly discussed, from the chimeric antigen receptor design to final production steps, passing through ex vivo T-cell handling, gene delivery methods, patient´s final product infusion observations or possible associated side effects of this treatment.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1
ISSN:	0165-2478 1879-0542
DOI:	10.1016/j.imlet.2019.10.014