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Scaling complex cell therapies from clinical to commercial : References

2026-04-10T19:16:00+01:00

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Reference links and supporting resources for ”Scaling complex cell therapies from clinical to commercial”

 

References 

  1. Flexible Requirements For Cell And Gene Therapies To Advance Innovation [Internet] FDA. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/flexible-requirements-cell-and-gene-therapies-advance-innovation 

  1. ICH Q10 Pharmaceutical Quality System. [Internet] International Council for Harmonisation (ICH). 2008. Available from: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf 

  1. EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 1 — Manufacture of Sterile Medicinal Products. Brussels: European Commission. 2022. Available from: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf 

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