Optimization of production for cell therapies Book Section
| Authors: | Wang, X.; Rivière, I. |
| Editors: | Jewett, A.; Fong, Y. |
| Article/Chapter Title: | Optimization of production for cell therapies |
| Title Series: | Breaking Tolerance to Anti-Cancer Cell-Mediated Immunotherapy |
| Abstract: | The development of cells as therapeutic agents to treat diseases has had unparalleled growth in recent years. Establishment and optimization of the manufacturing procedure are the prerequirement for the wide applications of such therapies. Determining the target product profile and the critical quality attributes, implementing the quality by design approach and understanding the mode of action are key steps for a successful process development endeavor. For a safe, cost-effective, and compliant cellular product manufacturing procedure, it is critical to integrate scientific knowledge, perform risk analysis, and connect measurable characteristics of the process to the final product release specifications during the optimization and process development phases. © 2023 Elsevier Inc. All rights reserved. |
| Keywords: | process development; cgmp; critical quality attribute (cqa); process characterization; quality by design (qbd); target product profile (tpp) |
| Book Title: | NK Cells in Cancer Immunotherapy: Successes and Challenges |
| ISBN: | 978-012822620-9 |
| Publisher: | Elsevier Inc. |
| Publication Place: | London, United Kingdom |
| Date Published: | 2023-01-01 |
| Start Page: | 169 |
| End Page: | 180 |
| Language: | English |
| DOI: | 10.1016/b978-0-12-822620-9.00004-5 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Book chapter: 8 -- Source: Scopus |
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