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Validation of the media fill method for solid tissue processing in good manufacturing practice-compliant cell production

Date

2021

Author

Oztel, Olga Nehir
Aydogdu, Nurullah
Karaoz, Erdal

Metadata

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Citation

Öztel, O. N., Aydoğdu, N., & Karaöz, E. (2020). Validation of the Media Fill Method for Solid Tissue Processing in Good Manufacturing Practice-Compliant Cell Production. Methods in molecular biology (Clifton, N.J.), 10.1007/7651_2020_331. Advance online publication. https://doi.org/10.1007/7651_2020_331

Abstract

Over the past few years, a large number of clinical studies for advanced therapy medicinal products have been registered and/or conducted for treating various diseases around the world and many have generated very exciting outcomes. Media fill, the validation of the aseptic manufacturing process, is the simulation of medicinal product manufacturing using nutrient media. The purpose of this study is to explain the media fill procedure stepwise in the context of cellular therapy medicinal products. The aseptic preparation of patient individual cellular product is simulated by using tryptic soy broth as the growth medium, and sterile vials as primary packaging materials.

Source

Methods in Molecular Biology

URI

https://www.doi.org/10.1007/7651_2020_331
https://hdl.handle.net/20.500.12713/1285

Collections

  • Makale Koleksiyonu [225]
  • PubMed İndeksli Yayınlar Koleksiyonu [985]
  • Scopus İndeksli Yayınlar Koleksiyonu [1526]
  • WoS İndeksli Yayınlar Koleksiyonu [1597]



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