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2022 ISPE Annual Meeting & Expo

SES206a - Advanced Data Analytics in Biologics Manufacturing

Nov 1, 2022 1:45pm ‐ Nov 1, 2022 3:15pm


In recent years, many pharmaceutical companies have been piloting advanced data analytics techniques to discover insights on the manufacturing processes. In this talk we will discuss a commercial biologics product case study in which we have consolidated disparate data sources that were previously not accessible in aggregate, including raw material specifications, manufacturing equipment, manufacturing process information, etc. and applied advanced data analytics including statistical modeling and machine learning. The goal is to unearth and understand the key drivers of an intractable cell culture challenge, and be able to improve the yield based on predictive control during the manufacturing process. We will discuss the findings, share lessons learned, and continue building advanced data analytics capability to enable more efficient and reliable production of our critical medicines for the patients.


  • Yiming Peng, PhD, Director, Nonclinical Biostatistics, Genentech Inc

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