Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Following successes of authorized chimeric antigen receptor T-cell products being commercially marketed in the United States and European Union, product development of T-cell-based cancer immunotherapy consisting of cell-based advanced therapy medicinal products (ATMPs) has gained further momentum....

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Bibliographic Details
Main Authors: I. Johanna, A. Daudeij, F. Devina, C. Nijenhuis, B. Nuijen, B. Romberg, C. de Haar, J. Haanen, H. Dolstra, E. Bremer, Z. Sebestyen, T. Straetemans, I. Jedema, J. Kuball
Format: Article
Language:English
Published: Elsevier 2023-12-01
Series:Immuno-Oncology and Technology
Subjects:
cellular therapy
ATMP
GMP
process development
clinical translation
Online Access:http://www.sciencedirect.com/science/article/pii/S2590018823000400

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http://www.sciencedirect.com/science/article/pii/S2590018823000400

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