Accelerating molecules to the clinic has placed emphasis on early investment in process development. A strategic combination of modeling and high throughput screening (HTS) defined a rational approach to process development and has been demonstrated to be a critical and essential part of both upstream and downstream process development for protein therapeutics. Utilization of Process Analytical Technology (PAT) tools has also changed how data is collected, as we develop processes enabling early decision making and advanced control strategies. In this presentation, we will focus on examples where modeling, high throughput screening and PAT tools have been utilized to shape process development strategies: (1) how modeling has increased the understanding of product quality attributes of the protein and directed process development activities, (2) high throughput upstream and downstream development enabling fast track process development, and (3) the use of PAT as an integral part of upstream and downstream process development to inform process decisions and enable robust process control.<br/>

Process development strategies for production of protein therapeutics

251st National Meeting (2016)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.