565. A Ready-to-Use Process for Large-Scale Plasmid DNA Manufacturing

doi:doi:10.1016/j.ymthe.2005.07.105

Abstract

Bringing a gene therapy or genetic vaccination drug candidate from the lab bench to the clinic requires considerable investment, not only in the organization of clinical trials but also in drug production. Usually, biotechnology companies and researchers rely on contract manufacturing organizations for GMP-compliant production of the therapeutic drug; however, in order to reduce cost, an increasing number of companies and research centers are now investigating in-house GMP production. Numerous small multipurpose GMP facilities have already been established at major international research centers, and many more are being planned.

Over the last decade, QIAGEN's robust plasmid DNA purification process has been successfully used in several gene-therapy manufacturing facilities, yielding between 100 mg and 30 g plasmid DNA ¹. Due to the unique separation characteristics of QIAGEN Anion-Exchange Resin, a single chromatography step is sufficient to produce high-quality plasmid DNA that has proven to be safe and effective in numerous pre-clinical and clinical trials across North America, Europe, and Australasia. Recent improvements in the QIAGEN process, such as vacuum-driven lysate clearing (patent pending) and RNase-free processing (patent pending) further facilitate large-scale production and increase yield and quality of the plasmid DNA.

QIAGEN has now made the Anion-Exchange Resin available to public researchers and companies. In combination with the buffer system and instructions for upstream and downstream processing this provides a turn-key solution, enabling researchers and companies to establish in-house plasmid DNA production process in minimum time.

In this presentation we review the equipment and building prerequisites for implementation of the QIAGEN manufacturing process and show data generated by in-house use of the QIAGEN process.

Abstract