Scalability 2023

Analytical innovation: meeting the demands of commercial viral vector manufacture

Cell & Gene Therapy Insights 2023; 9(1)


Published: 16 March 2023

As with most truly ground-breaking areas of innovation in the human medicines arena, the gene therapy field has not enjoyed a smooth transition into the commercial industrialized setting. As regulators and industry alike strive to build a deeper understanding of the underpinning biological and manufacturing process-related factors impacting the safety and efficacy of viral vector-driven products, the spotlight has fallen squarely on the analytical technology field. This eBook features a curated selection of content that explores the various challenges and drivers that are shaping the CMC and quality landscape for adeno-associated viral (AAV) and lentiviral (LV) vectors alike. It provides a uniquely broad yet detailed review some of the cutting-edge analytical tools that can deliver the insights and evidence required if the gene therapy field is to achieve lasting commercial success.