BioInsights - 1Viral vector production process intensification: analytics, automation, in-line testing, and more

1Viral vector production process intensification: analytics, automation, in-line testing, and more


Published: 18 January 2021
Expert Roundtable Video
Michael DiBiasio-White, Franz Gerner, Jessica Tate, James Warren, Susan D'Costa, Michael Delahaye, Paul Manzo Display Name 2

Michael DiBiasio-White

Senior Scientist at Affinia Therapeutics

Michael J White, Senior Scientist at Affinia Therapeutics where he is leading the process development efforts focused on novel AAV vector variants. Before joining Affinia, Michael held roles at Ring therapeutics where he led teams focused on designing processes and developing novel viral vector technologies for Anelloviruses.

Franz Gerner

Vice President, Technical Operations, at Sio Gene Therapies

Franz Gerner is Vice President, Technical Operations, at Sio Gene Therapies, where he is responsible for process development, manufacturing and analytical activities, including overseeing outsourced activities at CDMOs and CTOs. Prior to joining Sio Gene Therapies, Franz worked at Regenxbio, joining the company at an early stage and building up the Process Development team over the course of 5 years. He started to work in the AAV gene therapy field about 25 years ago.

Jessica Tate

Head of Science & Technology Development, Viral Vector Services, Thermo Fisher Scientific

Jessica Tate has spent the last 15 years producing, purifying, and characterizing various virus modalities, in a combination of industry and academic environments. Currently she leads Thermo Fisher Scientific’s Viral Vector Science and Technology team, who’s mission is to develop and/or employ novel state-of-the-art technologies in the manufacturing of viral vector gene therapies.

James Warren, Ph.D

Vice President, Pharmaceutical Development at Ultragenyx Gene Therapy

Dr. Warren has 27 years of experience in the pharmaceutical and biotechnology industry, with a focus in bioprocess development and manufacturing of viral vectors, viral vaccines, and biologics. At Ultragenyx, he leads a team of over 60 scientists and engineers, responsible for all early and late stage Process and Analytical Development of viral vector gene therapy products as well as Pilot Scale Manufacturing in the Woburn, MA Pilot Plant. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, and Shire. Earlier in his career, Jim spent 16 years at Merck & Co., Inc., where he led process development, technology transfer, and manufacturing sciences teams responsible for development of several clinical vector and vaccine candidates and the licensure of multiple commercial vaccines (RotaTeq®, Varivax®, ProQuad®, and Zostavax®). Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a Ph.D. in Molecular & Cellular Biology from Lehigh University.

Susan D’Costa

Senior Director, Technical Program Design in the Commercial Operations team for Viral Vector Services, Thermo Fisher Scientific

Susan D’Costa is currently the Sr. Director, Technical Program Design in the Commercial Operations team for Viral Vector Services, Thermo Fisher Scientific. In this role, she functions as SME for VVS’ viral vector manufacturing platforms and systems providing scientific and technical input for customer programs. Prior to this role, she served as the Head of Process and Analytical Development at Viral Vector Services, Thermo Fisher Scientific, formerly Brammer Bio for over three years. In her role as head of PD/ADA, she provided critical scientific input for projects developed and manufactured at VVS. She has built a robust team for the development, customization, optimization, scale-up and tech transfer of gene therapy vector process and analytics. Susan was also integral to developing robust QC analytics for incoming starting and raw materials and for the release of the clinical vector products in her role as Director of Quality Control at Brammer Bio/Florida Biologix. She holds a Ph.D. in Molecular Virology and has over 20 years of experience in molecular virology.

Michael Delahaye

Head of Viral Vector Industrialization, Cell & Gene Therapy Catapult

Michael is the Head of Viral Vector Industrialisation at the Cell and Gene Therapy Catapult and has almost 15 years of industrial experience within the cell and gene therapy sector. He leads a team of experienced scientists within the Viral Gene Delivery programme, responsible for managing the developmental output of the group within collaborative, commercial and supporting R&D operations. The team’s key focus is the development and delivery of robust manufacturing processes, supported by rapid, high resolution characterisation tools to facilitate the production of AAV based gene therapies. His team is also supporting the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture