The updated ICH Q14 guidance from the FDA revising analytical procedures used for release and stability testing has shown higher product quality expectations from regulatory agencies. As analytical studies become an indispensable requirement to progress the antibody-drug conjugate space forward, so has the need for rigorous analytical methodologies that ensure product quality ahead of regulatory submissions.

The 3^rd ADC Analytical Development provided a technical deep-dive into optimizing physiochemical methods to better quantify DAR and drug distribution, carry out size variant and charge variant analysis, develop bioassays to improve understanding of the potency in a timely fashion, and better utilize impurity assays to measure free-linker drug and overcome species separation, to ensure attendees are producing a high-quality product within regulatory boundaries.

Over 100+ Attendees including Daiichi Sankyo, Eli Lilly, ADC Therapeutics, AstraZeneca, gained an in-depth but holistic overview of all facets of analytical development that ensure you deliver a high-quality, safe and effective ADC that will progress through regulatory checkpoints.

Designed for analytical development, CMC, and quality control experts within the ADC field, this was an exciting opportunity to foster collaboration, address need-to-know analytical challenges shared by the entire community and set a framework for future regulatory clarity that you could not afford to miss.

Atteendee's optimized the development of physiochemical, potency and impurity assays to gain a better understanding of your final drug product and confidently meet regulatory requirements.