The aim of release testing of a vaccine batch is to show that a particular batch is consistent with and equivalent to the successive batches produced by the manufacturer and to the batches that have been shown to be safe and efficacious in clinical trials in humans. A description of the bioassays performed on all relevant lots should demonstrate the potency and activity of the active substance.
It is a necessary requirement in these assays to work in compliance with Good Manufacturing Practice (GMP), which ensures that products are consistently produced and controlled to these quality standards.
Our Quality Control laboratory performs batch release testing including potency assays.
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