(205d) Plasmid DNA Vaccine: Purification Platform Development

An E. coli-based platform process for production of plasmid DNA used in vaccines has been developed by Pfizer Biotherapeutics Pharmaceutical Sciences. The process includes a novel, scalable alkaline lysis step and three purification columns followed by an ultrafiltration/diafiltration step. This process was first demonstrated at lab scale purifying materials that met the required specifications including total proteins, endotoxins, genomic DNA, RNA and percent of supercoiled DNA. The process was later successfully implemented at pilot-plant scale to make >100 mg of highly purified plasmid DNA for regulatory toxicology material supply. Scaling up this process to GMP pilot-plant scale is judged to be straightforward and could produce several hundred milligrams of highly purified plasmid DNA required for a Phase 1 trial.