Virus bank testing
Quality control of virus bank testing encompasses all the biologics testing methods used to test and validate virus seed stocks used in biomanufacturing in order to ensure their potency, consistency and safety. As essential blocks of virus-based therapies – vaccine and gene therapy -, virus seeds require the highest level of tests to meet industry and regulatory standards (EMA, FDA, ICH, etc.), and to guarantee efficient bioprocesses.
Complementary to virus banking services in cGMP environment, Clean Cells has developed an extensive portfolio of cGMP-ready assays intended for virus bank quality controls from R&D to clinical setups (MVSS, WVSS). With hundreds of virus models handled over 20+ years, Clean Cells is a leading expert of methods relating to virus bank testing for release in the field of both the human and animal health industries.
Biosafety testing and characterization of Virus Banks
Virus seed stock testing should include a variety of assays to ensure safety and secure key quality attributes:
- Identity testing by qPCR or sequencing (Sanger our NGS)
- Microbiology test covering sterility testing, mycobacteria and mycoplasma detection
- Virus biosafety testing: confirms freedom from adventitious agents by cell culture assays, qPCR assays and in-vivo testing.
- Titration and propagation: demonstrates potency of virus banks
- Functional testing: depending on the medicinal product being manufactured, additional functional assays can be required as part of virus bank characterization.
Extent of biologics testing is defined based on a risk-assessment and regulatory requirements.
Virus seed stocks quality control services are supported by a multi-audited Quality Management System, for detailed records of testing procedures and results to generate comprehensive profile of the virus bank.
For more information, please do not hesitate to contact us.
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