Preparing for success in gene therapy purification

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 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 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.