Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Dr. Jeffrey C. Mocny and Cellares’ Anna McMahon

In this Q&A interview with BioPharm International®, Jeffrey C. Mocny, PhD, vice president of Regulatory Strategy at Abzena, and Anna McMahon, director of Regulatory Affairs at Cellares explore the implementation of risk-based strategies to navigate evolving global regulations and maintain high biopharmaceutical quality standards. Their discussion highlights how FDA guidance changes, adaptive clinical trial designs, and data integrity are transforming the drug development lifecycle. They note how, by embedding quality risk management into initial process designs and leveraging prior knowledge from contract development and manufacturing organizations (CDMOs), the industry can achieve greater manufacturing efficiency, faster innovation, and improved patient outcomes.