In our most recent Method Lifecycle Management webinar held Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach, Joseph A. Turpin, Director of Chromatography Products and Services at S-Matrix Corporation and Tran Pham, Business Development Manager at Waters Corporation, presented an overview of Quality by Design approaches to analytical method development (AQbD), the regulatory views on this approach, examples of design of experiments in AQbD, and case studies demonstrating software assisted AQbD method development.
Waters recently partnered with United States Pharmacopeia (USP) experts to host a webinar discussing the upcoming changes in the pending USP General Chapter on chromatography that will provide increased flexibility for gradient methods. Here’s an extended Q&A from the webinar.
“Assuming continuous improvement is a worthy goal, there is every reason to improve validated chromatographic methods if you’re working with the right instrument technology,” says Eric Grumbach of Waters. See what that means for developing and transferring methods for biologic drugs.
As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?