Virus Bank Characterization
Master Virus Seed Stock Characterisation
It is important to extensively characterise the Master Virus Bank, or Master Virus Seed Stock (MVSS) as this also provides assurance regarding characteristics of subsequent passages, including the Working Virus Bank, or Working Virus Seed Stock (WVSS). Stability of the geneotype and phenotype should be demonstrated at passages beyond the level used in the manufacturing environment (e.g. sequence and genetic stability).
Regulatory agencies recommend that virus seed stocks are tested using neutralising antiserum prepared in SPF animals. If neutralising antiserum is not available then an alternative strategy using PCR can be suggested.
Testing must also be performed for safety, purity and potency as required, including tests for identity, bacterial and fungal sterility, mycoplasmas, Mycobacterium tuberculosis (if appropriate), and adventitious virus testing.
Working Virus Seed Stock Characterisation
The WVSS should also be tested, but the extent of characterisation is dependant on the level of characterisation of the MVSS. Once it has been established that the MVSS is free of adventitious agents from the species the vaccine virus has been exposed to during isolation and passage history, the WVSS only needs to be demonstrated to be free of adventitious agents that could have been introduced during the manufacture of the WVSS.
Next Generation Sequencing
Next Generation Sequencing (NGS) can be used to confirm the identity of viral seed stocks as well as expression vectors used in vaccine or gene therapy products. BioReliance’s NGS platforms generate deep sequence coverage, enabling the confirmation of identity and the detection of even ultra-low frequency genomic variants often missed through conventional sequencing methods.
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