GMP Banking of Human Pluripotent Stem Cells: A US and UK perspective

Author:

Abranches Elsa,Spyrou Sofia,Ludwig Tenneille

Publisher

Elsevier BV

Subject

Cell Biology,Developmental Biology,General Medicine

Reference13 articles.

1. Pharmaceutical GMP: past, present and future-a review;Patel;Pharmazie. 2008,2007

2. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice (25/06/2019). https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf.

3. Directive 2004/23/EC of the European Parliament and of the Councilof 31 March2004 (25/06/2019). https://eur-lex.europa.eu/eli/dir/2004/23/oj.

4. Human Tissue Authority, The regulator for human tissue and organs (25/06/2019). https://www.hta.gov.uk/policies/eu-tissue-and-cells-directives.

5. Cellular & Gene Therapy Products, US Food & Drug Administration (25/06/2019). https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products.

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