Roundtable Discussion: Validating the Purification Process: Learning How to Set Protocols in Motion for Newer, Complex Modalities to Achieve FDA Quality Standards & Market Your Therapies
Time: 12:00 pm
day: Conference Day One
Details:
- Learning how to gain confidence in complex biologic characterization to better understand the downstream process before presenting to regulatory authorities and win approval
- Exploring how to portray adequate product and process understanding to facilitate the approval process
- Addressing the validation process for newer, more complex modalities to ensure regulatory preparation
