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


  • 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