Biotechnology Services
Gene Therapy Products |
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Cell bank and virus seed testing for adventitious agents
- Regulations require companies to demonstrate that viral vector preparations and packaging cell lines are not contaminated with adventitious agents such as bacteria, fungi, mycoplasma and viruses. Covance has many years of experience in this arena and is able to offer a comprehensive regulatory package to satisfy clients' requirements.
- Cell bank testing: These services are detailed elsewhere (see Cell bank, additive and bulk product testing). In addition to the standard tests described, specific assays will be required on a case-by-case basis. For example, owing to the association of adeno-associated virus (AAV) with adenovirus, specific testing for AAV is highly recommended in the Master Cell Bank, the Master Virus Seed Stock, and the final product for adenoviral vectors.
- Viral seed lot testing: Testing is essential to ensure that virus seed lots are free from adventitious agents. The approach taken depends on the product type. Assessment of the battery of assays to be performed on the virus seed lot is made on a case-by-case basis.
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