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MASS SPECTROMETRY WITHOUT LIMITS: Pioneer MS equipment and Automated Sample Preparation unit to boost New Therapies Development

Periodic Reporting for period 1 - MS-INFINITE (MASS SPECTROMETRY WITHOUT LIMITS: Pioneer MS equipment and Automated Sample Preparation unit to boost New Therapies Development)

Reporting period: 2019-05-01 to 2019-08-31

Conventional mass spectrometry is essential in traditional drug development and quality assurance. However, the pharma & biotech industry directs its drug development efforts towards large biomolecules (antibodies, gene therapy or nanoparticles) with increased efficacy and limited side effects. Currently available techniques do not keep up with the changes in drug development and as a result, are not suitable for the analysis of those new therapeutics with high molecular weight (>50kDa). The accurate and reproducible analysis is necessary for a successful drug development, to monitor the manufacturing process or to evaluate the quality of final product to guarantee efficiency for the patient. Similarly, novel analysis techniques are required for disease diagnosis and patient monitoring.
We have identified an unmet need to develop a novel solution for an analysis of large molecules, that could be used for routine analysis by a non-specialist.
We have evaluated the technical, commercial and financial feasibility of an Automatic Sample Preparation (ASP) unit together with an upgrade of mass spectrometer with the latest state-of-the-art components. Based on our experience we have prepared a preliminary design that will be further discussed with already identified and consulted external advisors. To increase the performance of the ASP unit, we will assemble and test a first prototype before producing a final ASP unit prototype.
We plan to launch MS INFINITE on the market in 2023. We have selected Ferritin measurements to be our entry market, therefore the clinical performance of MS INFINITE will be tested in two identified hospitals in Germany and Switzerland. By the fourth year on the market we plan to be present in 22 European countries. As a second revenue stream, we will be offering in house R&D projects for an analysis of large molecules for biotech & pharma companies and research institutes. We are in advanced collaborative agreements with miVital, Vifor, PTB and Swiss Tropical Health Care Institute.
Our financial evaluation of the project showed that MS INFINITE will reach profitability the fourth year on the market with a ROI of 2.3 and creation of at least 18 new jobs.
Our objective is to become a reference company for the detection of high molecular weight analytes. We will be first to introduce an automatic sample preparation (ASP) unit and offer highly accurate and reproducible mass spectrometry method to non-specialists. Moreover, the ASP unit will decrease the time needed for the sample analysis and the cost of analysis. With MS INFINITE, we will increase the quality of life of the patients, reduce health care cost and the drug development costs