Sustainable plasmid DNA strategies, achieving streamlined secure supply to clinic & commercialization
Cell & Gene Therapy Insights 2023; 9(3), 379–388
With many advanced therapy products reaching commercialization and an ever-increasing pipeline planned for transition to late-phase clinical studies, there is significant demand for reliable plasmid DNA supply. In addition, evolving and sometimes undefined regulatory requirements and quality standards present a range of opportunities and challenges for developers. This article will explore some of the common challenges encountered when sourcing plasmid DNA, and provide valuable recommendations that will help navigate the pitfalls in achieving sustainable plasmid supply to support clinical programs through to market. A case study will highlight key lessons learned to help developers set themselves up for success when working with CDMOs.