ADME and Bioanalytical Strategies for ADCs: Challenges, Emerging Technologies, and Regulatory Considerations

Antibody-drug conjugates (ADCs) are transforming cancer treatment, but their development brings unique challenges in the DMPK field, including ADME, bioanalysis, and regulatory registration. This webinar explores integrated DMPK and bioanalytical strategies for ADC discovery and development, grounded in recent analytical advances, global guidelines, and real-world experience.

Topics include bioanalytical approaches for assessing pharmacokinetics and biotransformation of ADCs, challenges associated with ADC bioanalysis, and opportunities enabled by emerging technologies. In addition, an ADME characterization decision tree and associated experimental approaches, integrated with regulatory considerations, will be presented to support the design and execution of MIST, DDI evaluation, and animal biotransformation studies of novel payloads. Advanced LC-MS techniques for untargeted profiling of payload-containing components and the investigation of ADC biotransformation will also be discussed. 

Whether you’re advancing an ADC program or addressing ADME and bioanalytical issues associated with ADCs, this webinar offers practical insights and technical solutions to support ADC optimization, development, and regulatory goals.

What You Will Learn

ADME study strategy and decision tree for characterizing novel payloads

Untargeted LC-HRMS method for studying payload release

HR Orbitrap MS for in-depth characterization of ADC biotransformation

Generic reagent and targeted 2D-LC-MS/MS for highly sensitive quantitative analysis

Regulatory aspects of ADME and bioanalytical studies of ADCs

Case studies

Watch On-Demand

Speakers:

Mingshe Zhu, Ph.D.

Scientific Advisor of DMPK, 

BioDuro

Jintang He, Ph.D.

Senior Principal Scientist,

Genentech