Validating a rapid analytical method for plasmid purity determination & platform harmonization
Vaccine Insights 2023; 2(2), 33–43
Vaccines and gene therapies require a significant DNA supply. Plasmid DNA (pDNA) is produced using E. coli fermentation methods in large, stainless-steel bioreactors. The process is inherently slow and expensive, with limited capacity, and is prone to batch failure. There are manufacturing optimization opportunities at each step of the pDNA workflow, through fermentation, cell harvest, cell lysis, concentration, and purification. The integration of well-designed technologies and process control analytics enables process scale-up and generates consistent and high pDNA yield at high qualities. CTech™ analytical solutions are designed to increase process understanding, reduce cycling time, increase process efficiency, strengthen process control, and minimize risk. During fermentation, variable pathlength technology (VPT) analytics enable bacterial growth optimization, better plasmid yield, and consistent processing. Additionally, VPT technology allows process analytics for the final steps of purification, concentration, and diafiltration to enhance recovery yields with high purity and low variability.