Potency Assay Development: A Keystone for Clinical Use

Author:

Torggler Raffaela,Margreiter Eva,Marksteiner Rainer,Thurner Marco

Publisher

Springer International Publishing

Reference37 articles.

1. EMA European Medicines Agency (2015) Reflection paper on classification of advanced therapy medicinal products. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification. Accessed 4 May 2020

2. FDA U.S. Food and Drug Administration (1998) Guidance for industry: guidance for human somatic cell therapy and gene therapy. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-human-somatic-cell-therapy-and-gene-therapy. Accessed 14 April 2020

3. EMA European Medicines Agency (2008) Guideline on human cell-based medicinal products. https://www.ema.europa.eu/en/human-cell-based-medicinal-products. Accessed 14 April 2020

4. EMA European Medicines Agency (2016) Guideline on potency testing of cell based immunotherapy medicinal products for the treatment cancer. https://www.ema.europa.eu/en/potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancer-0. Accessed 14 April 2020

5. FDA U.S. Food and Drug Administration (2011) Guidance for industry: potency tests for cellular and gene therapy products. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-tests-cellular-and-gene-therapy-products. Accessed 25 March 2020

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