End of Production Cell Bank Testing
An End of Production Cell Bank (EoPCB) is sometimes referred to as a Post Production Cell Bank (PPCB) or as cells at the limit of in vitro cultivation. These cells are tested to validate the production system to ensure that this is stable and that there are no contamination issues within the system. The timing of the sampling for an End of Production Cell Bank will vary between products and is made on a case by case basis and should be justified following the production process.
The testing requirements are two fold; the tests for stability and the tests for contamination (Biosafety). The requirements for the End of Production Cell Bank are very similar to that for the Master Cell Bank. The EoPCB requires Genetic Stability testing and direct comparison with the MCB. The tests include genetic analysis of the transgene using techniques such as Southern blotting, mRNA sequencing or transgene copy number; Identity is measured by Isoenzyme analysis. Contamination is determined by a number of tests including those for microbes (Sterility and Mycoplasma), adventitious virus (in vitro and in vivo, Transmission Electron Microscopy) and specific virus tests as determined by the process.
BioOutsource has developed validated assays for the majority of the different cell types used in the production of recombinant protein products, and depending upon your specific EoPCB testing requirements, offers the following Biosafety testing services:
- Sterility Testing
- Mycoplasma Testing
- in vivo Testing
- in vitro Testing
- Retrovirus Testing
- Bovine and Porcine Assays
- Electron Microscopy
- Species-Specific Assays
The Genetic Stability assays provided by BioOutsource can be found below:
Contact our biosafety experts to discuss your end of production cell bank requirements.