Viral Vaccines are required to under go multi stage testing with a variety of different assays is used to assure product safety and ensure product quality. This includes testing all the biological materials in vaccine manufacture, especially the initial components, which are the virus seed and the cell substrate. Different stages for testing are selected based on the maximum likelihood of adventitious agent detection and effect on product quality. a table shown below is a typical testing scheme; actual selected tests will depend upon the actual cell substrate, the product, and its manufacture. Additional tests may be included on a case-by-case basis depending upon the cell substrate and other biological materials as well as production conditions for vaccine manufacture.
Example biosafety testing scheme for Manufacture of a Viral Vaccine.
Meaning of symbols on example chart.
1 = tests may be different for cells versus intermediate and final products
2 =if applicable
3 = including ALV test in case of chicken cells
4 =may be combined with virus induction assays, as applicable
+ = required stage for testing
(+)= alternative stage for testing
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