As manufacturing networks expand, maintaining consistent process performance across sites becomes increasingly important. Variations in facility design, scale, and operating conditions can introduce heterogeneity that requires a more structured, data-driven approach. This session will outline how integrated digital tools—including digital twins, multivariate modeling (SIMCA), and computational fluid dynamics (CFD)—are applied to strengthen process understanding and support more consistent execution. These approaches enable process prediction and provide a more systematic basis for risk assessment across development and manufacturing. The discussion will also highlight how data-driven insights can support comparability across sites and scales, contributing to more reliable and scalable biomanufacturing.
Jihyeon Oh is a process engineer with over 14 years of experience in biologics process development, technology transfer, and GMP manufacturing operations for drug substances. She currently serves as Director of MSAT, where she leads scale-up/down activities and oversees technology transfer across manufacturing sites. In her role, she provides technical guidance to support the integration of tech transfer models and alignment of cross-functional activities. Her experience includes process development, scalability assessments, and risk-based facility fit evaluations. She has also contributed to the establishment of standardized tech transfer platforms to support consistent and reliable manufacturing operations.
Anjalee is an award-winning journalist who most recently lead on-air and digital reporting on healthcare for Yahoo Finance. That included leading the pandemic coverage through the first 9 months of the Trump administration. Her focus has encompassed the various segments under the healthcare umbrella, including payers, providers, pharmacies, life sciences and digital health. She has interviewed Fortune 500 CEOs, top health officials in the U.S. as well as global public health experts. Khemlani is known as a tough but fair moderator, never backing away from a challenging question, and has an enthusiasm that keeps audiences engaged.