CART manufacturing process and reasons for academy-pharma collaboration
| Autor: | Clara San Bartolome, J. Ramón Ortega, Iñaki Ortiz de Landazuri, Manel Juan, Natalia Egri, Marta Español-Rego |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Process management T-Lymphocytes Immunology Genetic Vectors Receptors Antigen T-Cell Immunotherapy Adoptive Biopharmaceutics 03 medical and health sciences 0302 clinical medicine Adoptive Cell Immunotherapy Neoplasms Manufacturing Industry Immunology and Allergy Humans Industry Good manufacturing practice Pharmaceutical industry Gene Editing Genetically engineered business.industry Manufacturing process Academies and Institutes Genetic Therapy Chimeric antigen receptor 030104 developmental biology Costs and Cost Analysis business Genetic Engineering 030215 immunology |
| Zdroj: | Immunology letters. 217 |
| ISSN: | 1879-0542 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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