558. cGMP Production of Plasmid DNA for Phase I Clinical Studies in an Academic Center

Phase I clinical trials performed at Memorial Sloan Kettering Cancer Center utilize plasmid DNA for active immunization and require the production of large quantities of clinical grade material. Therefore, the Gene Transfer and Somatic Cell Engineering Facility developed a process whereby 200 mg of plasmid DNA could be produced in a single production run in compliance with current Good Manufacturing Practice (cGMP). A dedicated cleanroom (Class 10,000 with Class 100 Biological Hood) is utilized for the production of the bacterial cell bank, the fermentation phase, the harvest and lysis of the biomass as well as the downstream processing (DP) steps to purify the plasmid DNA.