Streamlining And Standardizing Process Characterization

By Claudia Berdugo-Davis, Ph.D., Director of Process Development, Catalent Biologics; and Danielle Wittenwyler, Ph.D., Manager, Manufacturing Science & Technology, Catalent Biologics.

When every week counts on the path to commercial launch, your process characterization strategy can either accelerate or stall your program. For biologics developers navigating FDA's three-stage process validation lifecycle, the gap between rigorous characterization and compressed timelines is one of the most persistent challenges in drug substance development.

Building a deep understanding of your critical quality attributes (CQAs) and critical process parameters (CPPs) from the earliest stages of development is the foundation of a control strategy that protects product quality through every batch. But what happens when you cannot wait for every study to complete before advancing PPQ readiness?

This article explores how a platform-based process characterization approach, anchored in FMEA risk methodology and design of experiments (DoE), enabled a mAb program to run 11 upstream and 24 downstream studies within a fast-tracked timeline. You will learn how parallel workflows, consolidated documentation, and a dual-purpose critical-path roadmap allowed teams to de-risk PPQ initiation using at-scale historical data, even before all characterization studies were finalized.

You will also gain perspective on where shortcuts create downstream risk, including the cost implications of running method optimization and validation simultaneously, and why an incompletely locked process can demand expensive rework. Access the full article below to learn more.