Webinar

Abstract:

To progress a biological product to BLA stage and on to commercialization, several critical activities must be undertaken and key milestones must be met during late-stage development.

Using the experiences from the development of 100+ late-stage programs and the successful commercialization of 17 biological products, this webinar will share the perspectives gained and review some of the innovative process development, characterization, validation, control strategies, product quality modulations, and comparability studies undertaken at WuXi Biologics that led to the establishment of a robust and economically affordable commercial manufacturing process.

In brief, we will share the strategies and process innovations that enabled us to achieve a significantly reduced drug substance cost of goods (CoGs) from a typical level of $200-$1000/g to $35-$70/g.

Key Takeaways:

• Overall strategy for late-stage development of a commercial drug substance process.
• Process development approaches that address productivity, yield, quality, robustness improvement, and cost reductions.
• Considerations for process and product comparability studies.
• Introduction of the WuXiUI^TM ultra-intensified fed-batch bioprocessing platform that achieves three to six fold productivity improvements and 25 g/L titer during fed-batch culture mode.

Speakers:

Jun Tian, PhD, Vice President, Process Development

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