Evaluation Optimization of Large-Scale Plasmid DNA Production Process of Harvest, Resuspension, Lysis, and Neturalization at Large and Small Scale

Advancements in technology can improve industrial manufacturing, especially in the biopharmaceutical industry. However, the nascent state of most process technologies are derived from the scale-up of laboratory practices. Such is the case of GMP plasmid DNA manufacturing, which to date, heavily relies on decades old laboratory-scale process technologies to enable large-scale processing. This work explores the possible optimization of those processes through possible implementation of new technologies, such as single-use continuous flow centrifugation, as well as streamlining up-scaled processes, such as microbial resuspension, lysis, and neutralization. New solution recipes were develop and tested and compared to current industry standards. One set of new solution recipes produces less contamination in the pDNA product but produces less pDNA than the current industry standard