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 language | English |
|---|---|
| Pages (from-to) | 161-169 |
| Number of pages | 9 |
| Journal | Methods in molecular biology (Clifton, N.J.) |
| Volume | 1283 |
| DOIs | |
| Publication status | Published - 2015 |
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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)
Cite this
Media fill for validation of a good manufacturing practice-compliant cell production process. / Serra, Marta; Roseti, Livia; Bassi, Alessandra.
In: Methods in molecular biology (Clifton, N.J.), Vol. 1283, 2015, p. 161-169.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Media fill for validation of a good manufacturing practice-compliant cell production process
AU - Serra, Marta
AU - Roseti, Livia
AU - Bassi, Alessandra
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
KW - Advanced therapy medicinal products
KW - Aseptic validation
KW - Good manufacturing practice
KW - Media fill
KW - Quality control
KW - Thioglycollate medium
KW - Tryptic soy broth
UR - http://www.scopus.com/inward/record.url?scp=84923096809&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84923096809&partnerID=8YFLogxK
U2 - 10.1007/7651_2014_104
DO - 10.1007/7651_2014_104
M3 - Article
VL - 1283
SP - 161
EP - 169
JO - Methods in Molecular Biology
JF - Methods in Molecular Biology
SN - 1064-3745
ER -