Leveraging Integrated DS/DP Manufacturing To Mitigate CMC Risks And Simplify Commercial Supply

Lonza experts Raminder Bahia, Director of Program Management, and Fabien Walas, Senior Technology Transfer Lead DPS, dissect the strategic and operational advantages of consolidating Drug Substance (DS) and Drug Product (DP) manufacturing under a single CDMO framework. Drawing from their extensive experience with collaborative DS/DP projects, Raminder and Fabien reveal the keys to successfully managing intricate biologics programs across Lonza's global sites and demonstrate how this integrated approach directly benefits customers.

The session highlights how Lonza leverages several critical components to streamline regulatory submissions and achieve high-quality commercial outcomes.

Review concrete examples of how early alignment between DS and DP teams enables the proactive resolution of complex challenges related to biologics manufacturing, packaging, storage, and transport. By co-developing solutions and pooling expertise across Lonza’s global network, the team successfully met demanding customer expectations, maintained product quality, and adhered to stringent regulatory deadlines.