Working 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 Working Cell Bank (WCB) testing and characterization. Our team of experts can provide consultancy on the specific testing requirements of your cell line and cell banks.
Working cell banks (WCB) are prepared from the Master Cell Bank (MCB) and the biosafety testing requirements of the Working Cell Bank (WCB) are dependent upon the degree of testing that has been conducted on the Master Cell Bank (MCB).
Where extensive characterization has already been completed on the Master Cell Bank (MCB), the safety concerns should have already been evaluated and the required testing and characterization of the Working Cell Bank should be minimal.
Depending on the regulatory authority, this is typically limited to assessment of identity, stability and contamination by microbes, with virus testing only recommended where a recognized risk occurs. To characterize the genetic stability, the transgene is assessed using techniques such as southern Blotting, sequencing of mRNA and/or transgene copy number. Identity can be measured using DNA fingerprinting and the presence of microbes is determined using sterility assays and mycoplasma assays.
BioOutsource has developed and validated a range of different assays to characterize Working Cell Banks originating from different species that are used to produce biopharmaceutical and vaccine products:
- 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 working cell bank testing requirements.