期刊
BIOTECHNOLOGY PROGRESS
卷 31, 期 5, 页码 1433-1441出版社
WILEY-BLACKWELL
DOI: 10.1002/btpr.2136
关键词
quality by design (QbD); critical quality attributes (CQA); control lever; glycosylation; % high mannose; mannose
Pressures for cost-effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an essential feature of any therapeutic manufacturing process. The active control of product quality in a typical biologic process is challenging because of measurement lags and nonlinearities present in the system. The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. (c) 2015 American Institute of Chemical Engineers Biotechnol. Prog., 31:1433-1441, 2015
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