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Quality by Design: A CMO’s Perspective on Gaining Knowledge Faster and Better

Thought Leadership

From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development strategy has been intended to generate at-scale product for clinical trials as fast as possible. The resultant operational ranges have traditionally been either very narrow because of lack of supporting experimental studies, or statistically derived with little to no data from experimental design to support the outer ranges. Timelines are often built without an opportunity to identify critical aspects of the process, perform range finding experiments, or optimize the process. Additionally, fears of making “process changes” within the clinical manufacturing phase have prevented many processes from being more robust and operationally friendly. The resultant Process Control Strategy becomes narrow and / or possibly at risk of consistent excursions outside of the acceptable ranges. As molecules progress through the clinical phase and begin gearing up for commercial submissions, the amount of development and characterization may increase and many experiments must be repeated, adding to timelines and cost. Thus, by not following a well-defined development plan up front, a Quality by Design (QbD) approach, there is a potential increased risk of delaying commercialization.