Promises and challenges of a decentralized CAR T-cell manufacturing model
Autologous chimeric antigen receptor-modified T-cell (CAR T) products have demonstrated un-precedent efficacy in treating many relapsed/refractory B-cell and plasma cell malignancies, leading to multiple commercial products now in routine clinical use. These positive responses to CAR T therapy have...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-09-01
|
| Series: | Frontiers in Transplantation |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/frtra.2023.1238535/full |
| _version_ | 1827167246121697280 |
|---|---|
| author | Manan Shah Ashley Krull Lynn Odonnell Marcos J. de Lima Evandro Bezerra |
| author_facet | Manan Shah Ashley Krull Lynn Odonnell Marcos J. de Lima Evandro Bezerra |
| author_sort | Manan Shah |
| collection | DOAJ |
| description | Autologous chimeric antigen receptor-modified T-cell (CAR T) products have demonstrated un-precedent efficacy in treating many relapsed/refractory B-cell and plasma cell malignancies, leading to multiple commercial products now in routine clinical use. These positive responses to CAR T therapy have spurred biotech and big pharma companies to evaluate innovative production methods to increase patient access while maintaining adequate quality control and profitability. Autologous cellular therapies are, by definition, manufactured as single patient batches, and demand has soared for manufacturing facilities compliant with current Good Manufacturing Practice (cGMP) regulations. The use of a centralized production model is straining finite resources even in developed countries in North America and the European Union, and patient access is not feasible for most of the developing world. The idea of having a more uniform availability of these cell therapy products promoted the concept of point-of-care (POC) manufacturing or decentralized in-house production. While this strategy can potentially decrease the cost of manufacturing, the challenge comes in maintaining the same quality as currently available centrally manufactured products due to the lack of standardized manufacturing techniques amongst institutions. However, academic medical institutions and biotech companies alike have forged ahead innovating and adopting new technologies to launch clinical trials of CAR T products produced exclusively in-house. Here we discuss POC production of CAR T products. |
| first_indexed | 2024-03-12T02:33:09Z |
| format | Article |
| id | doaj.art-c0fdc35fe234422fbf64f1ee4a0c7abc |
| institution | Directory Open Access Journal |
| issn | 2813-2440 |
| language | English |
| last_indexed | 2025-03-21T02:01:14Z |
| publishDate | 2023-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Transplantation |
| spelling | doaj.art-c0fdc35fe234422fbf64f1ee4a0c7abc2024-08-02T20:45:42ZengFrontiers Media S.A.Frontiers in Transplantation2813-24402023-09-01210.3389/frtra.2023.12385351238535Promises and challenges of a decentralized CAR T-cell manufacturing modelManan Shah0Ashley Krull1Lynn Odonnell2Marcos J. de Lima3Evandro Bezerra4Department of Hematology, the James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH, United StatesDepartment of Cell Therapy Manufacturing and Engineering, the James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH, United StatesDepartment of Hematology, Cellular Therapy Lab, the James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH, United StatesDepartment of Hematology, The James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH, United StatesDepartment of Hematology, The James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH, United StatesAutologous chimeric antigen receptor-modified T-cell (CAR T) products have demonstrated un-precedent efficacy in treating many relapsed/refractory B-cell and plasma cell malignancies, leading to multiple commercial products now in routine clinical use. These positive responses to CAR T therapy have spurred biotech and big pharma companies to evaluate innovative production methods to increase patient access while maintaining adequate quality control and profitability. Autologous cellular therapies are, by definition, manufactured as single patient batches, and demand has soared for manufacturing facilities compliant with current Good Manufacturing Practice (cGMP) regulations. The use of a centralized production model is straining finite resources even in developed countries in North America and the European Union, and patient access is not feasible for most of the developing world. The idea of having a more uniform availability of these cell therapy products promoted the concept of point-of-care (POC) manufacturing or decentralized in-house production. While this strategy can potentially decrease the cost of manufacturing, the challenge comes in maintaining the same quality as currently available centrally manufactured products due to the lack of standardized manufacturing techniques amongst institutions. However, academic medical institutions and biotech companies alike have forged ahead innovating and adopting new technologies to launch clinical trials of CAR T products produced exclusively in-house. Here we discuss POC production of CAR T products.https://www.frontiersin.org/articles/10.3389/frtra.2023.1238535/fulldecentralizedCAR Tleukapheresischimericlentivirus |
| spellingShingle | Manan Shah Ashley Krull Lynn Odonnell Marcos J. de Lima Evandro Bezerra Promises and challenges of a decentralized CAR T-cell manufacturing model Frontiers in Transplantation decentralized CAR T leukapheresis chimeric lentivirus |
| title | Promises and challenges of a decentralized CAR T-cell manufacturing model |
| title_full | Promises and challenges of a decentralized CAR T-cell manufacturing model |
| title_fullStr | Promises and challenges of a decentralized CAR T-cell manufacturing model |
| title_full_unstemmed | Promises and challenges of a decentralized CAR T-cell manufacturing model |
| title_short | Promises and challenges of a decentralized CAR T-cell manufacturing model |
| title_sort | promises and challenges of a decentralized car t cell manufacturing model |
| topic | decentralized CAR T leukapheresis chimeric lentivirus |
| url | https://www.frontiersin.org/articles/10.3389/frtra.2023.1238535/full |
| work_keys_str_mv | AT mananshah promisesandchallengesofadecentralizedcartcellmanufacturingmodel AT ashleykrull promisesandchallengesofadecentralizedcartcellmanufacturingmodel AT lynnodonnell promisesandchallengesofadecentralizedcartcellmanufacturingmodel AT marcosjdelima promisesandchallengesofadecentralizedcartcellmanufacturingmodel AT evandrobezerra promisesandchallengesofadecentralizedcartcellmanufacturingmodel |