As biologics development accelerates and therapeutic modalities diversify, demonstrating comparability after implementing manufacturing process changes remains a critical challenge. Advances in process intensification, analytical technologies, and digital tools are reshaping how comparability may be assessed and executed across the product lifecycle. This session will explore the multifaceted nature of comparability strategies with case studies for antibody-drug-conjugates, vaccines, and gene therapy products. In close collaboration, process developers and analytical scientists address the scientific and regulatory challenges, but also the opportunities to reimagine comparability frameworks that enable speed, flexibility, and innovation - without compromising patient safety, product quality, or efficacy.

Speakers will share comparability challenges, experiences, and best practices for a successful regulatory outcome. A moderated panel discussion will engage participants in a critical dialogue on how industry and regulators can evolve expectations, foster global harmonization, and harness innovation to transform comparability from a regulatory hurdle into a catalyst for progress.

Session Speakers:

Side-by-Side Stress Studies Designed to Support Post-Change Shelf Life

Tawnya Flick, Gilead Sciences, Inc.

From Lyo to Liquid: Smart Post-Approval Comparability Strategies for Patient-Friendly Vaccine Reformulation Across Regions

Varnika Roy, GlaxoSmithKline

Comparability for Cell and Gene Therapeutics
Fan Zhang, Novartis Institutes for BioMedical Research (NIBR)

Building a Resilient Commercial Supply Chain for Antibody-Drug Conjugate Products: A Risk-Based Comparability Approach

Dipkumar Jagani, Astellas Pharma US, Inc.

Additional Panelists:

Patrick Lynch, CDER, FDA

Holly McCaleb, Pfizer, Inc.

Joanna Zhou

Appearances