[iNOVA4Health] Integrated continuous biomanufacturing: A new paradigm for biopharmaceutical production

iNOVA4Health Seminar

Title: Integrated continuous biomanufacturing: A new paradigm for biopharmaceutical production

Speaker: Chetan Goudar

Affiliation: Executive Director, Process Development at Amgen’s Thousand Oaks Campus

Host: Paula Alves - Animal Cell Technology Unit

Abstract:

While continuous cultivation of recombinant protein-producing mammalian cells has been practiced for decades with the first licensure of a therapeutic in 1993, downstream processing has largely been a combination of batch unit operations and only recently, has there been a focus on developing strategies for continuous purification. This development, coupled with the potential for a significant intensification of continuous cell culture, has resulted in the need for a holistic assessment of integrated continuous bioprocessing. Benefits of such an integrated approach over the conventional fed-batch/batch paradigms include high operational flexibility, much smaller facility footprint and an associated reduction in capital expenditure, increased volumetric productivity, cycle time and cost of goods reduction, and steady-state operation that can result in consistent product quality will be discussed.

Short Bio:

Chetan Goudar is an Executive Director of Process Development at Amgen’s Thousand Oaks Campus. His group is responsible for making cell lines and developing Drug Substance processes for all molecules in Amgen’s early-stage pipeline. Prior to joining Amgen in 2012, Chetan spent 13 years at Bayer HealthCare’s Process Development group in Berkeley, CA. He has a Ph.D. in Chemical & Biological Engineering from the University of British Columbia.