15-minute Webcast: Assessing Viral Clearance in Early Phase Process Development

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. A design of experiments (DOE) approach was utilized in this case study to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities by an anion-exchange (AEX) mixed-mode chromatography resin. Results from these studies have offered insights on the interactions between the resin and minute virus of mice (MVM) and xenotropic murine leukemia virus (XMuLV). A ceramic hydroxyapatite medium and a high-resolution cation-exchange (CEX) resin were also evaluated under typical conditions and are presented in this webcast. Overview: • Understand the interaction(s) between a model virus and chromatography resins • Evaluate the effect of critical process parameters • Assess the design space and optimal process condition • Use a pragmatic strategy to ensure viral safety in downstream processing Learn more about our process chromatography resins at https://www.bio-rad.com/library and request resin samples for your process development. Subscribe to the Bio-Rad channel: https://www.youtube.com/user/BioRadLi... We Are Bio-Rad. Our mission: To provide useful, high-quality products and services that advance scientific discovery and improve healthcare. At Bio-Rad, we are united behind this effort. These two objectives are the driving force behind every decision we make, from developing innovative ideas to building global solutions that help solve our customers' greatest challenges. Connect with Bio-Rad Online: Website: http://www.bio-rad.com/ LinkedIn:   / 1613226   Facebook:   / biorad   Twitter:   / bioradlifesci   Instagram: @BioRadLabs Snapchat: @BioRadLabs ©2020 Bio-Rad is a trademark of Bio-Rad Laboratories, Inc. in certain jurisdictions. All trademarks used herein are the property of their respective owner. Music used by permission granted by royalty-free license from Pond5.com