Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing
By Joschka Johannes Buyel (Bayer AG), Klaus Kaiser (Bayer AG), Kiran Andra (Alexion), Robert G. Luo (GlaxoSmithKline R&D), Alexis Henry (Biogen), Caroline Leveder (Sanofi R&D), Mark Richards (Eisai Inc.), Trish Connolly (BioPhorum Development Group)
This article is the second in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model justification. Their purpose is to provide reference documents for bioprocess professionals who will carry out small-scale model justification. In order to write the articles, surveys were conducted among BioPhorum workstream team members on the practices of conducting small-scale model justification. The results of the surveys are not presented in these articles but are available in an expanded BioPhorum white paper on the topic. Part 1 discussed the applications, including viral clearance, quality oversight, and design considerations, for justification of SSMs. This part covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup.