Patent submitted: “Full Process Control”

Since last year, we are collaborating with altona Diagnostics GmbH in a new ZIM (“Zentrales Innovationsprogramm Mittelstand”) project - “nanoControl - Development of Nanoparticles as Non-Infectious Full Process Controls for in vitro Diagnostics” financially supported by the Federal Ministry of Economics and Technology (BMWi). On our side, Dr. Sruthi Sreekumar is responsible for this project, supported by our bioinformatician Dr. Ratna Singh and our research technician Elisabeth Seiband. As a company, altona is developing in vitro diagnostic kits for e.g. viral diseases mostly based on real-time PCR. Increasingly, users of these kits as well as the regulatory agencies are asking for full process controls to validate the results. However understandably, it is not easy and safe to use known amounts of an infectious virus to be quantified as an internal standard. Our former post-doc Dr. Stephan Kolkenbrock who is now working at altona had the idea to develop chitosan nanoparticles loaded with parts of the viral DNA or RNA as such controls. In our joint project, we are further analysing the molecular interactions between chitosans and nucleic acids, both in silico and in vitro, as a prerequisite for the development of nanoparticles with defined physicochemical characteristics. These will be further improved to show even better performances with real-life samples under field conditions. Already, the experiments of the first year have been highly successful so that altona has just submitted a patent application based on the results. Once again, teaming up our fundamental knowledge of chitosans with the experience of a commercial partner promises to yield yet another intelligent application for this fascinating functional biopolymer.