Standardizing success: paving the way for streamlined viral vector manufacturing in gene therapy

Cell & Gene Therapy Insights 2023; 9(3), 363–368

DOI: 10.18609/cgti.2023.056

Published: 25 April
Raquel Martín-Ibáñez

“Continued research, development, and collaboration between academia, industry, and regulatory agencies will be key to advancing the field and ensuring that we are ready to build robust and scalable viral vector platforms.”

The fields of gene therapy and cancer treatment have witnessed remarkable progress in recent years with the development of new gene therapies for genetic disorders and cancer. As these approaches show promising results in clinical trials and move toward regulatory approval and commercialization, there is a growing demand for Good Manufacturing Practice (GMP)-grade viral vector manufacturing. However, several challenges must be addressed to optimize viral vector production, including selecting the right production system, optimizing downstream processing, and standardizing chemistry, manufacturing and control (CMC) methods and quality assays.