Webinar Overview

Antibody-drug conjugates (ADCs) are transforming oncology with their ability to deliver potent cytotoxic agents directly to tumor cells, combining the targeting precision of monoclonal antibodies with the cytotoxic potency of small molecule payloads. However, their structural complexity — spanning the antibody, linker, and payload components — introduces unique Chemistry, Manufacturing, and Controls (CMC) challenges that demand a carefully integrated and forward-looking development strategy.

From early candidate selection through clinical development and commercial manufacturing, every CMC decision carries significant implications for product quality, patient safety, and regulatory success. This webinar offers practical insights to help CMC scientists, project managers, and regulatory professionals navigate key decision points and build a robust ADC CMC strategy that supports both speed and quality.

Key Learning Objectives:

1.  Conjugation platform selection and its impact on DAR control and product homogeneity

2.  Analytical method development for complex ADC characterization

3.  Formulation and stability strategies 

4.  Regulatory and scalability considerations

Speaker: 

Dr. Tiejun Li

Vice General Manager, Head of CMC and PM, AsymBio