As more ADCs gain regulatory approval and the landscape becomes increasingly competitive, the 4th ADC Analytical Development Summit returns to the World ADC Event Series in Boston this April. This event will bring together experts to address the unique analytical challenges of antibody-drug conjugates and help you navigate an increasingly crowded industry. As regulatory expectations tighten and ADCs grow more complex, this summit will guide you in ensuring high-quality products and seamless regulatory submissions.

With the FDA’s updated ICH Q14 guidance raising the bar for release and stability testing, adopting advanced analytical methods is crucial to maintaining product quality. The summit offers a platform to explore how to meet regulatory requirements effectively while ensuring your ADC remains robust through its lifecycle, with case studies from experts in regulatory submissions.

ADC developers are working with novel payloads, linkers, and next-generation formats, such as multispecific conjugates, antibody-radio conjugates, and ADCs with increasing DAR. These advancements require tailored analytical strategies to address challenges in DAR quantification, drug distribution analysis, and impurity profiling. This year, we’ll delve into the methodologies needed to navigate these technical hurdles through deep-dive workshops and expert presentations.

The summit also explores how cutting-edge analytical tools enhance bioassays, improve potency measurement, and provide insights into ADC mechanisms of action. You’ll gain actionable strategies for refining impurity assays to quantify free drug and process-related impurities, ensuring high-quality products that meet global regulatory standards.