Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials

In the dynamic bioprocessing regulatory landscape, the development of a commercial manufacturing process that is compliant with regulatory expectations hinges on strategic planning and meticulous attention to raw material selection. Even the most foundational regulatory requirements can sometimes leave room for interpretation.

Join this roundtable of regulatory and raw material experts as they discuss navigating important quality decisions associated with raw material selection throughout the biologics manufacturing process. Get your questions answered on how to help drive the most efficient regulatory submission and review during your development journey from pre-clinical to licensure.

Learning objectives:

• Understanding raw material qualification and validation of a process
• Using quality attributes to help inform future decisions for scale up
• Distinguishing regulatory differences between excipients and other raw materials
• Selection criteria for raw materials and suppliers