Production of plasmid DNA in industrial quantities according to cGMP guidelines.

Qiagen offers a unique technology for plasmid manufacturing, working reliably for every parent plasmid. The process steps such as strain and clone selection, and fermentation optimization ensure optimal plasmid DNA yield and quality in the starting material. Master Cell Bank and Working Cell Bank manufacturing is then performed under cGMP conditions. A high-yield, low mechanical stress alkaline lysis procedure, followed by a proprietary endotoxin-removal step and anion-exchange chromatography ensures consistently high plasmid DNA quality. The material undergoes stringent quality control tests and is accompanied by a comprehensive quality control report and a documentation package for regulatory filing. The following chapter describes the necessary steps such as host cell selection, growth conditions, downstream processing, and quality assurance and control.