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Validation of the Media Fill Method for Solid Tissue Processing in Good Manufacturing Practice-Compliant Cell Production.
- Source :
-
Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2021; Vol. 2286, pp. 67-71. - Publication Year :
- 2021
-
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.
- Subjects :
- Biomedical Technology instrumentation
Cells, Cultured
Human Embryonic Stem Cells cytology
Humans
Practice Guidelines as Topic
Primary Cell Culture standards
Sterilization methods
Tissue Culture Techniques standards
Biomedical Technology standards
Culture Media standards
Primary Cell Culture methods
Sterilization standards
Tissue Culture Techniques methods
Subjects
Details
- Language :
- English
- ISSN :
- 1940-6029
- Volume :
- 2286
- Database :
- MEDLINE
- Journal :
- Methods in molecular biology (Clifton, N.J.)
- Publication Type :
- Academic Journal
- Accession number :
- 33349901
- Full Text :
- https://doi.org/10.1007/7651_2020_331