A Scalable Single-Use Two-Step pDNA Purification Process

The demand for biopharmaceuticals is increasing, and mRNA and viral vectors are experiencing some of the most rapid growth, leading to a need for reliable high-quality plasmid DNA (pDNA). pDNA is a crucial genetic engineering tool utilized to clone, amplify, or express genes in biotechnology applications. GMP-grade pDNA has many applications including DNA vaccines and gene therapy, as the production of viral vectors and mRNA relies on the availability of pDNA.

The primary objective of this study was to develop a process with increased productivity compared to the existing three-step purification method. The presented single-use two-step plasmid purification process utilizes anion exchange chromatography and thiophilic aromatic adsorption chromatography for the capture and purification of pDNA. Evaluate the performance of this scalable and sustainable two-step plasmid process.