How to achieve regulatory approval for viral vectors
Paul Cashen is a Senior Bioprocess Specialist at Pall, where he works on the downstream purification and analysis of viral vectors, monoclonal antibodies and recombinant proteins. From this experience, he writes about the process of developing and commercializing a new drug and obtaining regulatory approval for viral vectors.
I am fortunate enough in my role to work with various customers across all stages of the development pipeline for pharmaceuticals, from small-scale research and development, right up to manufacturing campaigns for clinical material and beyond, to commercialization of products. Each step on the pathway to regulatory approval comes with its own considerations and criteria that must be satisfied before being able to progress to the next. Firstly, the product has to be shown to work, and must be able to be sufficiently scaled-up to produce an appropriate number of doses per batch. Secondly, the product must pass through several clinical trial stages in order to demonstrate it is safe and effective…
