USP Standards for Cell-Based Therapies

Author:

Atouf Fouad

Publisher

Springer International Publishing

Reference18 articles.

1. van der Loo, J. C., & Wright, J. F. (2016). Progress and challenges in viral vector manufacturing. Human Molecular Genetics, 25(R1), R42–R52. https://doi.org/10.1093/hmg/ddv451. Accessed 28 Aug 2020.

2. May, M. (2020, February). Gene therapy dollar is waiting on viral vector dime. GEN, 40(2), 36–38.

3. Lipsitz, Y. Y., Timmins, N. E., & Zandstra, P. W. (2016). Quality cell therapy manufacturing by design. Nature Biotechnology, 34(4), 393–400. https://doi.org/10.1038/nbt.3525. Accessed 28 Aug 2020.

4. Alliance for Regenerative Medicine. (2014). Pharma and biotech survey. Alliance for Regenerative Medicine.

5. Zoon, K. C., & Yetter, R. A. (2012). The regulation of drugs and biological products by the Food and Drug Administration. In J. I. Gallin & F. P. Ognibene (Eds.), Principles and practice of clinical research. Elsevier.

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