Master Cell Bank Testing
The BioOutsource team has many years of experience in the characterization of cell banks and provides a comprehensive set of assays for Master Cell Bank (MCB) testing. Our team of experts can provide consultancy on the specific testing requirements of your cell line and cell banks.
Typically, basic testing such as sterility and mycoplasma is required on the pre-MCB and comprehensive characterization is initiated on the master cell bank. Biosafety testing of the master cell bank encompasses a range of activities including identity testing, evaluation of genetic stability and a number of different assays designed to detect the presence of potential contaminants that may arise from contaminated starting materials or adventitious infection during the production process.
A range of tests are used in the detection of contaminating agents including those to detect micro-organisms (sterility and mycoplasma), in vivo, in vitro assays, retrovirus infectivity assays and transmission electron microscopy to detect adventitious and endogenous viruses. In addition a series of species-specific virus tests are required for the different production cell lines (Bovine, Porcine, Insect, Mouse, Hamster, Human, Primate). To assess and determine the genetic stability of the cell bank a number of different techniques can be applied such as southern blotting, mRNA sequencing or transgene copy number; Identity is determined by DNA fingerprint analysis.
BioOutsource has developed and validated a range of different assays to characterize master cell banks originating from different species:
- Sterility Testing
- Mycoplasma Testing
- in vivo assays
- in vitro assays
- Retrovirus assays
- Bovine and Porcine assays
- Electron Microscopy
- Species-Specific assays
The Genetic Stability assays provided by BioOutsource can be found below:
Contact our biosafety scientists to discuss your Master Cell Bank characterization requirements.