Leveraging Analytical Methods and Control Strategies to Enable Complex ADC Development
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Robust analytical methods and fit-for-purpose control strategies are foundational to identifying critical quality attributes (CQAs), understanding product heterogeneity, ensuring batch consistency, and supporting ADC development from early clinical stages through commercialization. This presentation addresses key considerations for developing and validating ADC-specific analytical methods, including DAR distribution, free payload, conjugational heterogeneity, product-related impurities and functional potency. We will discuss how to build a lifecycle-based control strategy aligned with regulatory expectations, and share practical case studies to demonstrate how analytical solutions mitigate technical risks during process development, comparability assessment and global regulatory filings.
Key takeaways include:
-CQA identification and fit-for-purpose analytical method development for complex ADCs
-Lifecycle control strategy design across ADC development phases
-Practical case studies and risk mitigation for ADC analytical and QC workflows
Speaker
Jia Duo
Senior Direcotr, Head of Quality Control
Altruist Biologics
Dr. Jia Duo serves as the Senior Director and Head of Quality Control at Altruist Biologics, a wholly owned subsidiary of Innovent Biologics. He oversees analytical method development, transfer and validation, as well as quality control activities for biologic products including antibodies, ADCs, fusion proteins and peptides. Dr. Duo possesses extensive experience in the development and commercialization of antibodies and novel biotherapeutics, and has supported global clinical and marketing authorization filings for multiple biologic assets. Prior to joining Altruist Biologics, Dr. Duo spent eight years at Bristol Myers Squibb, where he built deep expertise in the development and validation of analytical methods for a broad range of large-molecule drugs spanning early clinical through post-marketing stages. He has also contributed to the drafting of multiple industry best practices and guidelines.
Moderator
