Developing a Comprehensive Product Understanding & Extended Characterization for Presenting a Robust Physicochemical Data Package for BLA, IND & FIH Trial Regulatory Submissions
Time: 8:31 am
day: Pre-Conference Day
Details:
Developing a comprehensive understanding of product attributes and conducting extended physicochemical characterization are essential to ensuring that ADCs meet the stringent requirements for regulatory submissions, including BLA, IND applications, and FIH trials. Extended characterization and continuous refinement of CQAs from discovery through to late-stage development enhance product consistency, efficacy, and safety, supporting robust regulatory submissions.
Join this workshop to:
• Discover the systematic evolution of CQAs and advancements in analytical techniques which enable ADCs to meet regulatory standards while improving clinical trial outcomes and commercialization readiness
• Explore how the identification and definition of CQAs evolve from early-stage
discovery to late-stage development, with a focus on improving product consistency and performance
• Discuss advancements in analytical methods (e.g., LC-MS, SEC, HIC) to monitor changes in CQAs as ADCs progress through development, ensuring robust data for regulatory submissions
• Examine how regulatory requirements influence the evolution of CQAs and ensuring that analytical development strategies are aligned with these evolving standards to support clinical trials and commercialization
