Quality by Design for Biotechnology Products
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*Steven Kozlowski, FDA 


Ensuring pharmaceutical product quality is of critical importance. Knowledge gained during the pharmaceutical development program is important for an enhanced understanding of product quality and provides a basis for risk management. Quality by Design (QbD), Pharmaceutical cGMPs for the 21st Century, and Process Analytical Technology are initiatives being applied to small molecule pharmaceutical development and manufacturing. Although the principles of these initiatives are applicable to biopharmaceuticals, there may be some unique considerations for these products. A number of approaches may facilitate the application of QbD to biotechnology products. Appropriate use and interpretation of experimental studies and modeling is an important part of QbD for these products.