Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
To ensure the safety and efficacy of biopharmaceutical products administered to patients, manufacturers are expected to measure and control impurities in their products, including the host cell components and process additives that may leach into the process stream and final product. Tracking the clearance of these residuals is an essential part of process development and characterization. Since residuals are typically present at varying levels throughout the process, analytical method development and optimization can be challenging. In addition, detailed regulatory guidance on acceptable limits does not exist for all residuals.
In this 75-minute Biopharm International webinar sponsored by Eurofins Lancaster Laboratories, Dr. Sheila Magil, Senior Consultant, will provide an overview of manufacturing challenges presented by residuals in biopharmaceutical manufacturing, as well as regulatory expectations. We encourage you to register for this webinar to learn about challenges presented by residuals in biopharmaceutical manufacturing, regulatory expectations, analytical approaches for cell- and process-associated residuals, a platform method technology for residuals, and matrix effects. In the meantime, if you like to learn more about BPTC’s CMC analytical, quality, and/or regulatory consulting services, please email Julie Adam.