Validation of the media fill method for solid tissue processing in good manufacturing practice-compliant cell production
Küçük Resim Yok
Tarih
2021
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
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.
Açıklama
Anahtar Kelimeler
GMP, Media Fill, Method Validation, Stem Cells
Kaynak
Methods in Molecular Biology
WoS Q Değeri
N/A
Scopus Q Değeri
N/A
Cilt
Sayı
Künye
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
