Speaker "Dave Williamson" Details Back
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Name
Dave Williamson
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Company
Biogen
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Designation
Director
Topic
Driving Yield and Quality through Data Analytics
Abstract
Over the last seven (7) years Biogen has developed a variety of analytics platform in support of our clinical and commercial biological manufacturing. The primary objectives of this work has been to increase yield and ensure process quality and control. I will share specific use cases with outcomes such as >100% increases in yield and adjusting for process variability during execution. While these techniques are quite developed for solid dose manufacturing within the biotech arena this is still an immature capability. Biogen has been a leader and continues to push forward innovation in this area. I will conclude with discussing where our current efforts are underway in the area of predictive models in support of Continuous Process Validation (CPV).