A clear mandate has emerged throughout the industry to improve the timelines from candidate identification to phase 1 clinical trials. The goal of reducing the time to phase 1, combined with increasing titers and regulatory requirements, presents novel challenges to downstream development. To meet these challenges, Boehringer Ingelheim has developed the BI-Purification Excellence (BI-PurEx) strategy to shorten the development time to clinical trials while improving process understanding during early development phases to ensure a safe,…