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Towards a commercial process for the manufacture of genetically modified T cells for therapy.
- Source :
-
Cancer gene therapy [Cancer Gene Ther] 2015 Mar; Vol. 22 (2), pp. 72-8. Date of Electronic Publication: 2015 Jan 23. - Publication Year :
- 2015
-
Abstract
- The recent successes of adoptive T-cell immunotherapy for the treatment of hematologic malignancies have highlighted the need for manufacturing processes that are robust and scalable for product commercialization. Here we review some of the more outstanding issues surrounding commercial scale manufacturing of personalized-adoptive T-cell medicinal products. These include closed system operations, improving process robustness and simplifying work flows, reducing labor intensity by implementing process automation, scalability and cost, as well as appropriate testing and tracking of products, all while maintaining strict adherence to Current Good Manufacturing Practices and regulatory guidelines. A decentralized manufacturing model is proposed, where in the future patients' cells could be processed at the point-of-care in the hospital.
- Subjects :
- Cell Lineage genetics
Cell Lineage immunology
Genetic Engineering
Hematologic Neoplasms immunology
Humans
Lymphocyte Activation immunology
Receptors, Antigen, T-Cell immunology
Receptors, Antigen, T-Cell therapeutic use
T-Lymphocytes transplantation
United States
Cell- and Tissue-Based Therapy
Hematologic Neoplasms therapy
Immunotherapy, Adoptive
T-Lymphocytes immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1476-5500
- Volume :
- 22
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Cancer gene therapy
- Publication Type :
- Academic Journal
- Accession number :
- 25613483
- Full Text :
- https://doi.org/10.1038/cgt.2014.78