Upstream Process Development with a kLa Criterion Within the BIOne Single-Use Bioreactor

[Article Title]

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.

A rigorous Design of Experiments (DoE) mass transfer characterization was initially conducted on the BIOne SUB, using the static gassing-out kLa determination method. The resulting model offered extensive insights into the system, enabling a deeper understanding of how variations in process inputs would impact the oxygen transfer rate. This enhanced understanding played a crucial role in the successful process development guided by a kLa central criterion. Furthermore, a shear-sensitive HEK-293 batch cell culture process was effectively transitioned from an orbital shaker flask to a Stirred Tank Bioreactor (STR) system.

The findings of this study affirm the effectiveness of utilizing kLa as a central criterion for bioprocess development. Moreover, these results highlight the remarkable suitability of the BIOne SUB for innovative upstream process development. Bioprocess scientists and engineers involved in upstream operations may find it beneficial to explore the utilization of the BIOne SUB and a kLa central criterion for their own process development and characterization investigations. Download this white paper to learn more.

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