[HTML][HTML] Towards a commercial process for the manufacture of genetically modified T cells for therapy

AD Kaiser, M Assenmacher, B Schröder, M Meyer… - Cancer gene …, 2015 - nature.com
AD Kaiser, M Assenmacher, B Schröder, M Meyer, R Orentas, U Bethke, B Dropulic
Cancer gene therapy, 2015nature.com
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 …
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.
nature.com