Preparing for success in gene therapy purification

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Preparing for success in gene therapy purification

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

As AAV-driven gene therapy continues to advance and mature as a commercial industry sector, the field’s focus intensifies on developing process tools and platforms that can deliver enhanced large-scale productivity and consistency at a reduced Cost of Goods (COGs). Furthermore, speed - to both clinic and market – is of growing importance in securing the financial future of biotech companies in the sector. Success in this increasingly competitive race will largely depend on who can most efficiently and cost-effectively develop a robust AAV production process that is fit for commercial purpose.

In this webinar, a panel of AAV downstream process development experts will deliver to the audience strategic and technical insights and practical advice on how to prepare early to meet a continually evolving set of manufacturing challenges, and avoid the sort of delays later in development that can prove fatal to gene therapy companies in the current funding environment.

Attend this webinar to learn how to:

Streamline AAV purification scale-up from the early stages of development through to commercial vector production
Enhance the “platformability” of your AAV downstream process, reducing timelines and costs
Optimize vector capture and polish steps
Satisfy regulators’ requirements around empty/full capsid separation
Support tech transfer success

Xiaotong Fu

Head of Downstream Process Development & Pilot Operation, Gene Therapy at Resilience

Dr. Xiaotong Fu currently serves as the Head of Downstream process development and pilot operation at Resilience technology development group. In this role, he focuses on supporting early and lates stage gene therapy programs, building platform processes for Adeno-Associated Virus (AAV) and Lentivirus (LVV), and managing CMC activities from development to GMP.

Prior to his role at Resilience, Dr. Fu was leading downstream process development at Biogen, supporting its early and late stage AAV portfolio. Additionally, he led the development of Biogen's plasmid process team and the high-throughput process automation team. Dr. Fu holds a doctoral degree in Chemical and Biomolecular Engineering from Johns Hopkins University, and he earned his bachelor’s degree in biotechnology from Shandong University.

Andrew Tustian

Senior Director, Preclinical Manufacturing and Process Development at Regeneron Pharmaceuticals

Andrew leads the viral vector process development group at Regeneron Pharmaceuticals, focused on developing bioprocesses for Adeno-associated virus (AAV) based viral vectors. Andrew has worked at Regeneron since 2009. Prior to moving to gene therapy Andrew co-led the purification development group for protein therapeutics, working on Fc-fusion, monoclonal antibody, and bispecific processes. He has worked on the process development for the FDA-approved drugs Dupixent®, Libtayo®, Inmazeb™, Kevzara®, Evkeeza™ and Praluent®, and helped develop the bispecific antibody platform at Regeneron. Andrew received his doctorate in biochemical engineering from University College London and his undergraduate masters in biochemistry from the University of Oxford.

Ashish Sharma

Associate Director, Process Development at Oxford Biomedica

Ashish Sharma is as an Associate Director at Oxford Biomedica (US) LLC, and is responsible for managing client services and the downstream platform and process development activities for multiple viral vector modalities. He holds an MS in Chemical Engineering from Rensselaer Polytechnic Institute, Troy, NY, and has over eighteen plus years of experience in process development, troubleshooting, characterization, and scale-up of purification processes for viral vectors, fusion proteins and biologics. Extensive experience in leading pre-pivotal and pivotal process development, qualifying small scale models, process characterization, in process control strategy, comparability protocols, viral clearance, and IND/BLA submission.

Eugene Sun

Field Application Scientist, Bioproduction Group at Thermo Fisher Scientific

Eugene Sun is the Field Application Scientist for the Northeast region of North America and is responsible for providing technical support for POROS and CaptureSelect chromatography resins. Prior to joining Thermo Fisher Scientific Bioproduction Group in 2021, Eugene supported Amgen's Pivotal Drug Substance Technologies group in Cambridge, Massachusetts and was responsible for the development, characterization, and scale-up support of downstream processes to enable commercial advancement of programs from clinical trials to marketing application. Prior to that, Eugene started his career supporting MedImmune/AstraZeneca's early drug discovery / pre-clinical pipeline down in Maryland as a member of the Purification Process Sciences department. Eugene has over 10 years of extensive bench-scale experience developing both early and late-stage purification processes across all downstream unit operations for monoclonal antibodies, various formats of bispecific antibodies such as Bispecific T-Cell engagers (BiTEs), and biosimilar programs. Eugene earned his Bachelor of Arts in Biochemistry and Music from Bowdoin College.