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Webinar

webinar modified on 10/10/2023

Strategic Process Innovations Drive to Reduce CoGs for Biologics Commercial Manufacturing in Single-use Bioreactors
Jun Tian, Ph.D.
Vice President, Process Development, WuXi Biologics

To advance a biological product to BLA stage and subsequent commercialization, several critical activities must be undertaken and key milestones must be achieved during late-stage development. Drawing on insights gained from over 100 late-stage programs and the successful commercialization of 17 biological products, this webinar will explore the perspectives acquired and discuss innovative advancements in process development, characterization, validation, control strategies, product quality adjustments, and comparability studies conducted at WuXi Biologics. These efforts have established a robust and cost-effective commercial manufacturing process. We will highlight strategies and process innovations that have significantly reduced the cost of goods (CoGs) for drug substance from a typical range of $200-$1000 per gram to $35-$70 per gram.

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