Consistency as tool to support in vitro batch potency testing in GMP production.

Abstract

There is great interest in the veterinary vaccine field to move away from in vivo release tests for vaccines to reduce cost and testing time, improve consistency and of course the 3Rs (reduce, refine, replace). A brief overview of Good Manufacturing Practice (GMP) and the consistency approach is discussed below and an overview of how manufacturers can use the consistency approach and GMP controls along with statistical analysis of processes at each stage of the production process (starting materials, antigen and finished product) to build in quality and reduce the need for in vivo finished product tests. A final summary and outline of some challenges we will face in moving this approach forward is covered in conclusion.