The FDA's Quality by Design (QbD) directive emphasizes the importance of comprehensive bioprocess characterization and understanding in future bioprocess development. It is recommended that process development incorporates a central criterion that describes the extracellular environment, aligning with this philosophy. Accordingly, we conducted innovative HEK-293 batch process development within the BIOne SUB, employing a kLa central criterion to establish operational definitions for our volume-dependent parameters.
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