By Muriel Richard, Regulatory Expert, Marie-Gaelle Roger, Head of Biotechnology Quality, and Jiangli Yan, Director, North America Delivery, BioReliance® End-to-End Solutions, MilliporeSigma
Analytical methods are used throughout upstream and downstream processes to help ensure the desired molecule is being produced with the desired purity. The overall strategy for establishing the program, however, varies depending on the stage of the company and requires an appropriate balance of speed, risk and cost, all while ensuring quality. Driven by the need for rapid advancement towards key milestones, what should an early-stage company think about when it comes to their analytical program? What necessary information should a basic analytical program include? And what is the risk of short-cuts in analytical development? In this ebook, our experts share some critical success factors for your analytical program and how a risk-based approach can effectively get you to your next milestone.