Ying Cai
Executive Director - Manufacturing Sciences & Technology Ultragenyx Pharmaceutical Inc.
Ying Cai is the Executive Director of Manufacturing Science and Technology at Ultragenyx, where she leads technology transfer and process validation for AAV gene therapies. She also led Downstream Process Development and Formulation Development at Ultragenyx and served as the CMC lead for a clinical-phase program. With over 20 years of experience spanning early-stage product development to commercial launch, Ying has held various leadership roles at several biopharmaceutical companies, including Sanofi, Biogen, Merck, and two contract development and manufacturing organizations (CDMOs). She brings deep technical expertise across multiple modalities, including AAV, plasmid DNA, oligonucleotides, biosimilars, antibodies, antibody-drug conjugates, and fusion proteins. Ying holds a Ph.D. in Chemical Engineering from the University of Arkansas at Fayetteville and a B.S. in Biochemical Engineering from Zhejiang University in China.
Seminars
- Comparing triple transfection and transient systems for their ability to rapidly support early-stage programs, while evaluating their scalability limits at clinical and commercial scales
- Exploring how plasmid-heavy approaches create supply challenges at large scale, and whether dual plasmid systems or stable cell lines can reduce dependency on GMP plasmid supply
- Debating which transfection or cell line strategy best supports PPQ runs, regulatory alignment, and robust COGs to ensure long-term viability of gene therapies
