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Quality by Design (QbD): Seeing the Glass as Half Full

As the biopharmaceutical manufacturing industry grows and becomes global, companies face demands to improve quality, while reducing costs and increasing output. The road to achieving these goals is through the adoption of QbD. A paradigm shift, when adopted by the FDA in 2004, QbD is modernizing the approach to pharmaceutical development by providing the industry with regulatory flexibility, increased development and manufacturing efficiency, and providing opportunities for innovation.

A recent article authored by BPTC consultant Brendan Cooney entitled; “Quality by Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development”, describes the current best practices concerning the implementation of QbD in the manufacture of monoclonal antibodies. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials impacts the final product. Historically, product quality has been assured by either end product testing (drugs) or by strict and narrow control of the manufacturing process without a comprehensive understanding of the link between process parameters and product quality attributes (biologics). When QbD is properly implemented, quality is built into the process rather than being tested into the product, allowing for incremental process changes to be made within defined ranges without needing prior regulatory approval.

BPTC’s 2nd edition of “The Development of Therapeutic Monoclonal Antibody Products”, due to publish in September 2016, provides extensive coverage of QbD as applied through the CMC development cycle. This report provides a roadmap covering strategy, technical and regulatory requirements for the development of a monoclonal antibody product from initial discovery through the filing for first in human clinical trials.


Blog article by: Brendan Cooney