Webinar Overview

Antibody-Drug Conjugates (ADCs) represent a fast-growing field of biologics. Similar to other antibody-based biotherapeutics, a huge number of possible structural variants lead to complexity in development and quality control. While development efficiency is becoming more and more critical, well-planned and risk-based development strategies are highly desired.

This presentation will outline a phased and QbD-based development and CMC Control strategy. Key principles from the literature and regulatory guidelines will be reviewed. High-level examples of applications relating to product CQAs, specifications, analytical methods, process changes and comparability will be shared. In addition, AsymBio’s growing capabilities, as well as the updated track record of supporting global partners in Biologics and ADCs, will be highlighted.

Key Learning Objectives

1. The principles of QbD-based CMC development strategy

2. Phase-appropriate development strategy for CQA, specifications, analytical methods, process change and comparability

3. Highlights of AsymBio’s growing global presence

Speaker

Zhaofeng Ding

Executive Director, CMC Lead, AsymBio