COMMERCIALIZING GENE & CELL THERAPIES: NAVIGATING THE ROCKY ROAD FROM PROCESS DEVELOPMENT TO MANUFACTURING
February 25, 2021
Presented by: CBET in partnership with Pall Biotech.
Moderator: Julian Rosenberg, PhD, Associate Director, CBET
Abhay Thakur, PhD discussed how cell and gene therapies have the potential of revolutionizing medicine in the 21st Century. As companies move rapidly from the bench to clinic, many face scale-up challenges. The utilization of scale down models for all unit ops from bioreactors to downstream purification is very useful to define the design space and ensure a robust and repeatable process. Three case studies are presented which illustrate various strategies for viral vector production both in adherent and suspension cell cultures.
ABOUT THE SPEAKERS
Commercial Development Manager, Pall Gene Therapy, Americas
Kristin joined Pall in 2014, after spending over ten years in vaccine and viral vector manufacturing and R&D, including scale-up and GMP production. Kristin has held several positions within Pall- initially as a Single-Use Sales Specialist before moving on to be a Biotech Integrated Solutions Sales Manager. Most recently, Kristin has joined the new Gene Therapy Division of Pall Biotech as Commercial Development Manager for the Americas.
Abhay Thakur, PhD,
Team Manager, PDS Downstream
Abhay Thakur is currently leading a team of scientists in the US accelerator process development services. His group primarily focuses on the development of downstream processes of viral vectors and proteins for gene therapy, oncolytic, and biologics. Abhay joined Pall in 2018 as a senior scientist and supported several viral vector projects involving the optimization and scalability of therapeutic products. Abhay obtained his degree in 2010 from CCMB India in the field of biochemistry and did 5 years of postdoc at UMASS Amherst studying protein folding.