From Lab To Large-Scale Process Validation: Mastering Regulatory Requirements

For complex biological molecules, the path from laboratory-scale development to Biologics License Application (BLA) approval depends on strategic planning well before submission.

At the Festival of Biologics in Basel on 15 October 2024, Evelyn Sollner presented a CDMO perspective on planning late-stage chemistry, manufacturing, and controls (CMC) activities with the ultimate filing goal in mind. The session introduces a tailored five-step approach to BLA planning, with particular emphasis on process characterization and its role in preparing for later development milestones. It explores how CMC activities can be structured around the specific product, manufacturing process, development timeline, and acceptable level of risk, recognizing that each program has its own requirements.

The presentation further considers how a CDMO partner can contribute throughout the planning process, helping align development activities with the intended regulatory submission.

Explore the five-step framework to understand how the different planning stages connect and how a structured, product-specific approach can help guide late-stage CMC development toward BLA filing.