A Q&A: Achieving Biologics License Application Success Using A Structured Approach

Developing an effective CMC strategy requires a thorough understanding of a drug and its unique characteristics, in order to design a manufacturing process that ensures consistency throughout the product’s life cycle. While the primary purpose of the strategy is to satisfy the requirements of regulatory authorities, safety and quality remain at the core of a CMC program. Therefore, designing your strategy using a structured approach that achieves the goals of your program while also reducing time and risk is essential to delivering an effective drug that patients need and deserve.

Lonza Pharma & Biotech’ Jason Osman, PhD, Director, Head of Proposals, and John McGuire, PhD, Global Head of Regulatory Affairs, recently presented the webinar, Achieving Biologics License Application Success Using A Structured Approach. In it, Drs. Osman and McGuire discussed the critical CMC elements of a product’s life cycle and how Lonza Biologics applies its knowledge and experience to provide the regulatory submissions support and strategy necessary for a successful BLA application. The following Q&A session was held after the webinar, where Drs. Osman and McGuire addressed attendee questions about Lonza’s structured approach to developing a CMC strategy.