Potency Bioassays on Biological Products
Biological potency assays are a critical piece of the regulatory approval process for therapeutic products. There are many types of bioassay and they can be assessed at various stages in the development process, but the potency bioassay is a defined requirement for approval into most global markets. We are able to assist clients in assessing their requirements, conducting the potency testing and interpreting the results of this bioassay.
Additionally, as the pharmacopoeial regulations are changing to allow for the use of alternative validated methods, we are currently engaged in a Knowledge Transfer Partnership with a local University to develop and bring in-house a non animal assay which would allow us to move away from the current in vivo method.
At Wickham Laboratories, we are committed to reducing, refining and replacing testing in laboratory animals and have a dedicated in vitro team investigating viable alternative methods for these types of testing.