Long-term plasmid storage feasible
plasmid DNA, raising the prospects for the technology as a new
source of APIs.
Germany's PlasmidFactory has published long-term stability data for its plasmid DNA, which the company hopes will become an active pharmaceutical ingredient (API) for drugs such as DNA vaccines and gene therapeutics.
The promise of using plasmids as APIs is considerable but storage has emerged as a real problem. If plasmid DNA is kept in non-optimal conditions, its structure degrades and the supercoiled (ccc) topology of the molecule can be converted to inactive forms (open circular and linear).
The study was performed in collaboration with the Max-Delbrück-Center for Molecular Medicine in Berlin and shows that stable storage of plasmid vectors can be achieved at -80 degrees centigrade rather than at 4 degrees centigrade over a period of 13 months.
The collaborative study is supported by data obtained with PlasmidFactory's proprietary capillary-gel-electrophoresis (CGE) technology and in vivo data from gene transfer by jet injection.
PlasmidFactory was founded in 2000 and manufactures Good Manufacturing Practice (GMP)- and research-grade plasmid DNA for researchers in the fields of transfection and drug delivery, virus production, nano-biotechnology, gene therapy, cell- or tumor therapy and DNA vaccination.
The backbone of the company's technology platform is its expertise in using CGE to quantify the structural diversity of plasmid DNA. It claims that CGE is the only reliable method of defining the stability of DNA drugs during storage according to International Conference on Harmonisation (ICH) guidelines.
