Orthogonal Methods for Empty/Full AAV Characterization: Enabling Regulatory Confidence and Lifecycle Management

Time: 11:30 am
day: Conference Day Two

Details:

• Discuss the need for “regulatory confidence” in complex modality analytics. FDA (and other agencies) want reliable, orthogonal data for product quality attributes
• Discuss lessons learned from validating orthogonal methods (AUC, SEC-MALS, mass photometry, CD-MS, UV-Vis), and how the scientific community (including USP) approaches method selection, orthogonality, and dispute resolution
• Discuss harmonization efforts through CDMO working group on AAV methods

Speakers:

Brett Howard Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both Read more