Advancing AAV manufacturing: strategic insights and cost-effective solutions for the future of gene therapies

Michael White is currently the Head of Process Development at AffiniaTx where he leads a team focused on building high performing processes and manufacturability screens for novel AAV capsids. His expertise is in end-to-end virus and viral vector production, including building innovative molecular systems to enable high yielding virus and vector expression platforms. He holds a Ph.D from Purdue University in Molecular and Structural Virology where he studied flavivirus assembly. Prior to AffiniaTX he worked at Ring Tx developing a novel expression platform for a new class of viral vectors. Before that he was at Medimmune (AstraZeneca) working in the early buildout of their AAV capabilities and processes. His passion lies in enabling the cross-talk between early R&D and CMC to build successful expression systems for novel delivery technologies.

Ying Cai is the Executive Director of Manufacturing Science and Technology at Ultragenyx, where she leads tech transfer and process validation for AAV gene therapies. Prior to this role, she headed 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 across the early, late, and commercial stages of drug development and manufacturing, Ying has held various leadership roles at several biopharmaceutical companies, including Sanofi, Biogen, Merck, and two contract development and manufacturing organizations (CDMOs). She has strong technical expertise across a broad range of modalities, including AAV, plasmid DNA, oligonucleotides, 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.

Roland Pach holds a doctoral degree in molecular parasitology from the University Fribourg, where he analysed the intracellular trafficking of transgenic RNA in trypanosomes.

At Roche, Roland is the global CMC analytical technical lead in the cancer vaccines and cell and gene therapy (CGT) area for more than 15 years. In his assigned area, he represents Roche-Genentech in external development projects, at industrial consortia like CGT BioPhorum and at numerous successful due diligence projects of in-licensing candidates or at merger of companies in the CGT fields. As editor and author at Springer Nature, he published several white papers and articles describing the current challenges of manufacturing and analysis of CGT drug products.

In his second role at Roche as global technical development leader, he successfully led new formats like immunotoxins from pre-clinics into entry to human (EiH, Phase 1).