On-Demand Webinar

Application of QbD Principles to Ultrafiltration Operations in Bioprocessing

Duration: 1 Hour
Speaker: Michael Payne, Senior Technical Biosafety Consultant, Merck

Abstract: Tangential flow filtration (TFF) is widely used in biopharmaceutical processes from upstream such as cell or viral harvesting and purification, to downstream such as protein concentration and diafiltration, as well as in final formulation. Today’s biopharmaceutical industry is under pressure from regulatory organizations to be able to meet increasing levels of compliance, and from pharmaceutical buying advocates and the financial community to show better operating economics. We will explore the role that quality by design (QbD) plays in meeting the challenges of these pressures while being able to ensure that final product quality is maintained or improved. The use of QbD tools and approaches will be applied to the drug product development process, the scale-up and to the manufacturing process. The identification and interrelationship of critical process parameters (CPPs), critical product quality attributes (CQAs), target product profiles (TPPs) and the use of risk assessment will be shown to help ensure that process parameters are maintained within the desired range to ensure product quality and reliable process operation. The webinar will offer fundamental practical information on the use of QbD in critical processes using ultrafiltration technology to meet risk and quality based reviews.

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