Applied Automation and Mechanistic Modeling for Purification Development of Challenging Molecules under Accelerated Timelines

Applied Automation and Mechanistic Modeling for Purification Development of Challenging Molecules under Accelerated Timelines. This talk presents a case study in the practical application of automation and mechanistic chromatography modeling in early stage (FIH) purification process development. High-throughput screening and modeling are used in conjuction to support PD and subsequent tech transfer of a cation-exchange polishing step for an mAb with high aggregate burden. Overall, the proposed workflow allowed for timeline acceleration, process improvement, and derisked tech transfer, enabling the toxicology study to support IND

Presented by Scott H. Altern, Senior Scientist II at AbbVie Bioresearch Center, Worcester, MA

Scott H. Altern is a Senior Scientist II at AbbVie Bioresearch Center in Worcester, MA, working in purification development. He graduated from Rensselaer Polytechnic Institute in 2023 with a PhD in Chemical and Biological Engineering from Prof. Steven Cramer’s group, specializing in mechanistic modeling of multimodal chromatography. Since then, Scott has driven the development and implementation of mechanistic modeling at AbbVie for both early- and late-stage biologics pipelines. His efforts have enabled multiple IND and BLA filings, enabling accelerated timelines and reduced cost of process development and process characterization for mAbs and complex multispecifics. Scott has also driven the use of high-throughput screening for process development, including its synchronous use with mechanistic modeling. Beyond modeling, he has led multiple FIH programs in process development, tech transfer, viral clearance studies, and IND authoring – demonstrating himself as a versatile contributor to both the scientific and business aspects of industrial downstream bioprocessing. In regard to scientific contributions, Scott has authored 13 publications with ~130 citations in high profile journals such as Journal of Chromatography A and Biotechnology Progress. He has presented at numerous scientific conferences, including Recovery of Biological Products, Recovery Modeling Workshop, PREP, ACS, BPI, Biotalk, and Bioprocessing Summit.

Followed by a live question and answer session