CMC Analytical Comparability: Methods & Strategies for Biologics

CMC Analytical Comparability: Methods & Strategies for Biologics is organized by Fleming and will be held from Feb 11 - 12, 2026 at Vienna, Wien, Austria.

Benefits of Attending:
Understand

• The regulatory requirements for characterization, comparability, similarity
• Principles of protein structure and comparative analytics

Learn

• How to define Protein Analytical Program & Critical Quality attributes
• To design of an analytical strategy for comparability / similarity studies

Gain

• Five steps to demonstrate comparability
• New developments in Structure/ Function relationship
• Protein Characterization according to ICH Q6B

Topics:

• Analytical Comparability of Biologics (NBE & Biosimilars)
• Case studies of analytical comparability studies pre- and post-approval
• State-of-the-art protein analytics of CQAs
• New developments in antibody structure and analytics
• Case studies highlighting practical challenges and solutions
• In vitro pharmacology