Validation of the Media Fill Method for Solid Tissue Processing in Good Manufacturing Practice-Compliant Cell Production.
Methods Mol Biol
; 2286: 67-71, 2021.
Article
em En
| MEDLINE
| ID: mdl-33349901
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Esterilização
/
Tecnologia Biomédica
/
Meios de Cultura
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Técnicas de Cultura de Tecidos
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Cultura Primária de Células
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article