The 2020-2022 COVID pandemic taught the entire society that our bodies deal with deadly viruses by producing the special defense molecules – antibodies. On the other hand, the antibodies themselves are the protein molecules that could be “on request” designed and produced outside of our bodies. In this case, the antibodies are referred to as “biotherapeutics” and constitute a critical life-saving class of drugs. Developing antibody-based drugs is one of the current powerful responses of our society to life-threatening diseases, such as cancer. However, the processes of antibody-drug development and drug quality monitoring are challenging scientifically and technologically.
Mass spectrometry is the analytical technique that can provide very detailed qualitative and quantitative information on the antibodies. It works by accurately weighing the antibody molecules as the whole and their parts and recording the data about the antibodies in the form of a “mass spectrum”. Due to the very large amounts of information contained in these mass spectra, companies that produce mass spectrometers tend to reduce the size of the files that contain information on antibodies by taking away some of the information. Therefore, the conclusions that can be drawn with this information are not as complete and not as accurate as could be without data reduction/truncation. For example, not all proteoforms of antibodies can be detected, with those present in the minor amounts missing from the reports. However, the minor components can be essential for the overall biological function and activity of the antibodies.
Moreover, even if the scientists had the special software tools that would allow them to extract information from the full or unreduced data (mass spectra), they would not be able to apply these software tools, as many of the modern mass spectrometers employed for antibody analysis do not provide these unreduced data – a limitation imposed by the instrument manufacturers. The latter is done primarily due to the technical challenges.
The A2MSTools project aimed to increase the amount of information that scientists can obtain about the antibody molecules by providing the access to the unreduced data from the mass spectrometers and by equipping scientists with the software tools for processing and analysis of these unreduced data sets. These capabilities were first developed as the innovations in the precursor EU initiative, the FET project TopSpec, and included an electronic device – FTMS Booster BioPharma – to access the unreduced data from the mass spectrometers and the software tools –Peak-by-Peak BioPharma and FTMS Simulator BioPharma – to process and analyze the unreduced (and reduced) data. The A2MSTools objectives were thus to evaluate the developed innovations in their operational environment – in the analytical laboratories equipped with the mass spectrometers that are used to analyze the antibodies. The project provided the answers to the practical questions – how to install these innovative products in the laboratories, what is their impact on the processes of antibody analysis, how are they considered by the scientists – would they use them? Moreover, the project also considered the business opportunity of bringing these innovations to the market – what are the competitors, what intellectual property rights are to be secured, and what are the potential markets and the end-users.
