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Quality by Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development

By: B. Cooney, et al

Reprinted with the permission of BioProcess International ,
Quality by Design (QbD) is a modernized approach to pharmaceutical development that is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate and improve the manufacturing process within defined ranges without obtaining prior regulatory approval. 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). According to FDA guidance released in January of 2011, product quality cannot be assured by testing alone. In the QbD paradigm, quality is built into the process rather than being tested into the product. This article is Part 1 or two that describes the current best practices concerning the implementation of QbD as related to the manufacture of monoclonal antibodies.