This work describes the combined use of high throughput technologies and novel applications of process capability methodology to drive efficiency and robustness in biologics process development and process characterization. Process capability is commonly measured by Ppk; however, it is typically not evaluated until a sufficient number of commercial lots have been executed at which point there may be limited opportunity to make process adjustments to enhance robustness. This work presents a case study in which prior knowledge and SME input have been utilized to assess process capability during development to assess likelihood of long-term robustness, establish readiness for scale-up/technology transfer, and identify focus areas for process characterization. This work also discusses implementation of the high throughput Ambr250 bioreactor system with automated sampling for process development and characterization which has driven significant efficiencies in execution time and cost. The combination of high throughput technologies and novel application of process capability methodology can be used together to expedite early insight into potential process vulnerabilities, provide a common platform to understand risk and inform decision making, and provide clear targets against which to measure process success, ultimately resulting in higher process knowledge and process robustness at launch.

Using high throughput technologies and process capability methodology to drive efficiancy and robustness in process develoment and process characterization

ACS Fall 2021

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