Jianxin Guo
Director - Regulatory Chemistry, Manufacturing & Controls Biotechnology Eli Lilly & Company
Jianxin Guo is Director of Regulatory CMC Biotechnology at Eli Lilly and Company, with over 10 years of experience in the development and regulatory submission of antibody-drug conjugates and bioconjugates. She previously held roles at Pfizer for more than 13 years, where her work spanned ADCs, mAbs, vaccines, and gene therapy — giving her a uniquely broad perspective across complex biological modalities. She has authored or co-authored multiple publications on ADC-related topics and has presented at various industry conferences on ADC analytical and process development.
Seminars
Monday 12th October 2026
Laying Out ADC CQAs & Understanding Regulatory Quality Perspectives as Complex Biologic & Small Molecule Therapies
- Contextualizing CQA requirements from approved and marketed ADCs
- Breaking down CQA considerations across small molecules and biologic ADC components
- Supplementing CQA expectations with regulatory CMC guidance from available health authority published guidelines
