Media fill for validation of a good manufacturing practice-compliant cell production process

Marta Serra, Livia Roseti, Alessandra Bassi

Research output: Contribution to journalArticle

Abstract

According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process.

Original languageEnglish
Pages (from-to)161-169
Number of pages9
JournalMethods in molecular biology (Clifton, N.J.)
Volume1283
DOIs
Publication statusPublished - 2015

Keywords

  • Advanced therapy medicinal products
  • Aseptic validation
  • Good manufacturing practice
  • Media fill
  • Quality control
  • Thioglycollate medium
  • Tryptic soy broth

ASJC Scopus subject areas

  • Molecular Biology
  • Genetics
  • Medicine(all)

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