Downstream Processing 2023

A scalable single-use two-step plasmid purification process

Cell & Gene Therapy Insights 2023; 9(9), 1175–1182

DOI: 10.18609/cgti.2023.155

Published: 1 November 2023
Innovator Insight
Peter Guterstam, Hans Blom, Simon Aberg, Linda Hagman, József Vasi

The current global demand for biopharmaceuticals is over US$300 billion, with an estimated growth of at least 12% annually. One of the fastest growing areas of biopharmaceuticals are mRNA and viral vectors—a fundamental prerequisite for both of these is a reliable source of high-quality plasmid DNA (pDNA). For both gene therapy and DNA vaccine applications, clinical grade pDNA with a percentage of supercoiled pDNA above 80% is usually required. Plasmids used in bioprocess applications are commonly in the range of 5–20 kb. Here we present a scalable single-use two-step pDNA purification process using a 7.3 kb model plasmid. In a high level comparison with an existing three-step purification process, it can be concluded that the two-step process provides a significant reduction in both process time and buffer consumption. In combination, this gives advantages from a sustainability perspective.