3rd Annual ADC Analytical Development Summit Hilton Boston Back Bay, Boston

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 3rd ADC Analytical Development will provide 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 you are producing a high-quality product within regulatory boundaries.

Join 100+ experts including Daiichi Sankyo, Eli Lilly, ADC Therapeutics, AstraZeneca, and many more to gain 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 is 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 cannot afford to miss.

⌛ Event Dates & Venue

16 Apr - 18 Apr 2024, 8:00 am - 3:45 pm

💸 Website & Tickets

Go to Event Website
Event Hashtag:
Ticket Pricing:
Drug Developer - Conference Day Only: USD 2999.00, Drug Developer - Conference + Workshop Day: USD 4297.00, Academic - Conference Day Only: USD 2599.00, Academic - Conference + Workshop Day: USD 3697.00, Solution Provider - Conference Day Only: USD 3699.00, Solution Provider + Workshop Day: USD 5097.00

◑ Topics | Categories