ABSTRACT
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Virus filtration is one component in the overall strategy to minimize transmission of infectious pathogens for biological products. Recombinant products such as monoclonal antibodies are expressed by mammalian, bacteria or yeast cells in fermentors, and within ascites fluid, or fluids from transgenic mammals. Mammalian cell lines may contain endogenous viruses that are generated in the bioreactor. Endogenous retroviruses are expressed because the retroviral genome is integrated into the cell line and cannot be screened-out during the creation of the Master Cell Bank. This causes retrovirus like particles, or RVLP’s, to be produced within the bioreactor. Products can also become contaminated by adventitious viruses which enter the process streams.
