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Upstream Process Development with a kLa Criterion Within the BIOne Single-Use Bioreactor | Aspen Xchange
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Modern upstream bioprocess development is evolving. The Quality by Design (QbD) directive by the United States FDA expressed how a simple demonstration of bioprocess functionality should no longer be considered a sufficient capstone for process development. Rather, a higher level of process understanding should be obtained. Such understanding should be established through the execution of robust characterization studies and demonstrated through the engineering of strategic process parameters. Such strategic process parameters are essential for the consistent manufacturing of biological drug substances. Therefore, strategic process parameters are necessary to meet quality standards and support final drug product safety and efficacy. Learn More