Innovative approaches that address current challenges in gene therapy viral vector manufacturing
Production of viral vectors, such as adeno-associated virus and lentivirus, is a complex process and requires innovative approaches to prevent their degradation during manufacturing, handling and storage. As scaling to larger volumes can exacerbate these challenges, early consideration of process development at the commercial scale is critical.
This article gives an overview of the significant improvements that have been developed at each step in the manufacturing workflow:
- Upstream, we discuss partial automation in scaling up plasmid expansion to maximize titer at scale.
- Downstream, a novel cell lysis solution overcomes shear-induced damage during processing without REACH concerns.
- During formulation, using well-characterized and optimized excipients greatly improve virus stability and quality.
Learn more about the current challenges in gene therapy viral vector manufacturing, and potential solutions to meet safety and efficacy requirements, clinical and market demands and cost of goods targets.
Authors
Arvind Srivastava, Ph.D.
Technical Fellow, Research - Bioprocessing
Dr. Arvind Srivastava is a Vice President at Avantor, leading contract development and manufacturing organization (CDMO). Before joining Avantor, Dr. Srivastava was Research Advisor at Eli Lilly and Company, where he managed drug product development from early development stage through commercial registration. Dr. Srivastava did his postdoctoral training from the University of North Carolina at Chapel Hill, NC, USA. He got his Ph.D. degree in biochemistry from the prestigious Tata Institute of Fundamental Research (TIFR) and M.S. in chemistry from the Banaras Hindu University (BHU). Dr. Srivastava has published numerous papers in international journals and has been frequently invited to present his research at the national and international conferences.