Lessons learned in building high‐throughput process development capabilities

Abstract

Companies have adapted high‐throughput techniques for process development to different levels. Some companies are beginning to incorporate high‐throughput process development (HTPD) techniques at a level which is approachable for the beginner user (example: plate‐based resin screening for purification) and others have sophisticated robotic platforms which are in routine use for new pipeline products for upstream, downstream, analytics, and just now starting in the protein formulation area. This mini review serves to summarize how companies have set up and are using HTPD capabilities, including the need for user‐groups to improve the likelihood of success. The focus will be a practical summary of the utility and limitations of these approaches.