Leveraging Structural Characterization & NMR to Improve Developability, Product Quality & Regulatory Confidence for Protein Therapeutics

• Applying NMR to characterize higher-order structure and conformational integrity of protein therapeutics to generate detailed structural insights that complement traditional analytical methods and increase confidence in product quality attributes
• Leveraging NMR for product characterization assessments to detect structural changes arising from manufacturing, formulation, process modifications, or storage conditions that may impact therapeutic performance
• Integrating NMR-derived structural data into regulatory strategies and submissions to support higher-order structure evaluation throughout product development and lifecycle management

Speakers:

Mats Wikstrom

Associate Director & Group Leader

Amgen Inc.