Short Course on Comparability

This course offers a comprehensive overview of comparability in biological products, including key topics such as manufacturing changes, lifecycle management, and patient safety. The morning session will cover global regulatory guidance, including ICH Q5E, WHO guidelines, and regional perspectives from the FDA, EMA, and PMDA, alongside scientific and technical considerations like analytical similarity, clinical requirements, and risk-based approaches. The afternoon session will feature applied case studies on therapeutics (monoclonal antibodies), vaccines (multivalent, process scale-up), and cell and gene therapies, highlighting unique challenges like autologous versus allogeneic products and process impact. The course will conclude with an interactive group discussion on best practices for planning comparability exercises.

08:30 – 12:15 | Regulatory Frameworks and Guidance

This session will provide a comprehensive overview of comparability in biological products, highlighting its definition, importance, and role in ensuring patient safety throughout the product lifecycle. Speakers will discuss the key drivers of comparability assessments, including manufacturing changes and lifecycle management. A global regulatory perspective will be presented, covering international guidelines such as ICH Q5E and WHO recommendations, along with regional frameworks from the FDA (U.S.), EMA (EU), PMDA (Japan), and regulatory authorities in emerging markets including China, India, and Brazil. Scientific and technical considerations will be explored in detail, with emphasis on analytical similarity assessments, non-clinical and clinical requirements, and risk-based approaches. The session will conclude with a Q&A and discussion, offering insights into common regulatory expectations, pitfalls to avoid, and lessons learned from real-world experience.

13:15 – 16:30 | Applied Case Studies

This session will explore how comparability is approached across different product types, highlighting both common principles and unique challenges. Speakers will address key considerations for therapeutic biologics such as monoclonal antibodies, including manufacturing change scenarios, the role of advanced analytics, and clinical bridging requirements. For vaccines, the focus will turn to comparability in multivalent formulations, process scale-up, technology transfer, and case studies drawn from seasonal influenza and COVID-19 vaccines. The discussion will then shift to cell and gene therapies, where comparability presents distinct complexities—ranging from autologous versus allogeneic approaches to the impact of raw material and process changes, alongside evolving regulatory guidance. The session will conclude with an interactive group discussion, offering lessons learned from case studies and sharing best practices to help participants more effectively plan comparability exercises for diverse product types.