592. High Quality Grade Plasmid DNA for Indirect Clinical Applications

Abstract

Amongst other applications, our plasmid DNA is used in the GMP-compliant production of recombinant viruses, antibodies and RNA, where these are the active pharmaceutical ingredients (API) used in clinical trials. Here, it is not always necessary to produce the plasmid DNA under GMP as well, in order to use it for such applications. An alternative is the so-called High Quality Grade plasmid DNA which is highly purified and well-characterised and, hence, meeting the requirements of most regulating agencies.High Quality Grade plasmid DNA is produced in our facility based on a research cell bank (RCB) and the very effective, patented ccc Grade DNA technology. A number of quality controls, both to the cell bank and to the plasmid DNA product, ensure that the final result is a product designed especially for the intended application and that complies with the appropriate regulatory standards.PlasmidFactory's new facility for the production of this high purity plasmid DNA is now operating successfully in new, modern labs where plasmid DNA of the highest quality is being produced in accordance with the EMEA guideline CHMP/BWP/2458/03. To ensure product safety, substances of animal origin are not used at any stage of the entire process, guaranteeing maximum possible product purity by reliable exclusion of contaminants such as bacterial chromosomal DNA or damaged plasmids. Only one plasmid is produced in each area - different plasmids are not produced in parallel in the same lab.