Quality By Design (QbD) For Biologics From A CDMO Perspective

By Claudia Berdugo-Davis, Ph.D.; and Anurag S. Rathmore, Ph.D.

The implementation of Quality by Design (QbD) principles in biologics development and manufacturing plays a critical role in ensuring the production of high-quality, consistent biologic products. Biologics are inherently complex and subject to variability, making it essential to adopt a proactive, systematic approach to identify and address potential risks early in the process. Central to QbD is a thorough understanding of both the product and the manufacturing process, alongside comprehensive risk assessments and robust process control strategies. By integrating quality into every stage of product design and manufacturing, QbD not only ensures product consistency but also aligns with key objectives such as patient safety, regulatory compliance, and commercial success.

The principles of QbD aim to enhance process robustness, reduce the likelihood of deviations, and optimize manufacturing efficiencies. However, applying QbD to biologics presents unique challenges, including the need for specialized knowledge, technology, and resources to monitor and control process variables effectively. This article delves into these challenges, examining the importance of a solid scientific foundation in biologics development and manufacturing, and offers insight into the essential elements for successfully implementing QbD. By understanding and addressing these challenges, companies can better position themselves to achieve reliable, high-quality biologic products that meet the expectations of both regulatory bodies and patients.