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Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Keynote

Keynote: Challenges in Characterization and Comparability of Advanced Therapies

Monday, May 5, 2025
1:00 PM - 2:00 PM ET
Location:Webster

Inspiring Innovation

Viral vector-based gene therapy products are rapidly moving through the clinic for many applications with many focused on rare diseases and diseases with a high unmet medical need. With many of these offering a potential one-time treatment and effective cure, many product candidates move quickly through the development cycle with many changes often requiring comparability assessment. This session will focus on the evolution of analytical methods during this process looking at several examples of method modifications and the correlation of orthogonal methods for comparability assessment. The session will include case studies on late-stage comparability changes for advanced modalities.

Learning Objectives:

  • Gain an understanding of and ideas to develop and improve analytical control strategies for advanced therapies.
  • Discuss options and strategies for comparability assessment of advanced therapies and regulatory strategies that have been used to meet regulatory health agency expectations.
  • Exchange ideas with colleagues, subject matter experts and regulators.
  • Learn what is needed for advanced thereapies when accelerated approvals are granted by health authorities.