SynBio scale-up challenges for small molecule Pharmaceutical Actives

Title: SynBio scale-up challenges for small molecule Pharmaceutical Actives

Speaker:  Dr Tim Bowser (Chief Technical Officer, River Stone Biotech Inc)

Abstract: Drawing on River Stone Biotech’s development of a commercial scale yeast-based bioconversion process for an advanced pharmaceutical intermediate, the presentation will outline both the typical scale-up challenges for a synbio process as well as the unique challenges presented by the pharmaceutical regulatory environment. Technical and regulatory challenges will be highlighted and examples given of how River Stone has overcome these hurdles.

Bio: Tim has had 40-year Industry career with a key theme of extracting commercial value from Industry-Academic collaborations. Tim spent 32 years with GlaxoSmithKline (GSK) with extensive experience in technical and business roles including 10 years as a member of GSK’s global Active Pharmaceutical Ingredients (API) executive and was responsible for the development and scale up of multiple advanced intermediates and API manufacturing processes resulting in excess of $100m in investment. Drawn into molecular biology and synthetic biology via an Industrial Placement at the University of York (UK) in 2013/14 Tim worked on molecular breeding of plants, this work resulted in 3 papers in the journal Science as well as 5 patent families. While in York,  Tim became a project lead on a GSK Synbio project for opioid alkaloid synthesis and 6 years ago joined River Stone Biotech working on a SynBio project for the production of opioid antagonists. Tim is currently the industry lead on research projects at the University of Melbourne and Monash Institute of Pharmaceutical Sciences.