Navigating Biopharma Commercialization: The Interplay of Regulatory Affairs, Process Development, and Manufacturing to Ensure Drug Quality

This webcast features: Yves Scheurer, manager, regulatory affairs, Lonza & Robin Schumacher, late-stage expert, Lonza.

In this webinar, join Lonza to explore the essential alignment between regulatory affairs, process development, and manufacturing in biopharmaceutical commercialization. Their expert speakers will discuss how integrating these functions ensures drug quality, safety, efficacy, and enables navigation of the complex regulatory landscape.

This webinar draws attention to the commercialization of microbial bioprocesses, though the playbook that is presented can also be applied to other technologies in Lonza’s portfolio.

First, gain insight into regulatory guidelines, with a focus on chemistry, manufacturing, and controls (CMC) documentation. Then, learn how effective regulatory affairs support can expedite global compliance and accelerate the commercial filing process.

Finally, discover how regulatory guidelines shape manufacturing processes, with practical insights on applying quality risk management, defining critical quality attributes (CQAs), and building robust control strategies that ensure consistent product quality from development through commercialization.

Watch this webinar to understand how the synergy between regulatory and operational processes drives compliance, assures process control, and ultimately delivers high-quality products to market.

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