The technology
The FASS technology measures solubility through the Solvent Redistribution (SR) method. This method detects the solubility and aggregation of compounds by measuring how the solvent redistributes around the solute molecules (Figure 1). With increasing solute concentration, solute monomers transition to stable aggregates. In-between fully dissolved monomers and stable aggregates, there is a concentration range where different types of structures (dimers, trimers, etc.) co-exist. The distribution of solvent molecules around these structures change dynamically – hence the term Solvent Redistribution.
Relative to the monomer state, there is an increase in the number of solvent molecules around the solute at the onset of aggregation that can be used a metric to detect the solubility limit. Solvent Redistribution method can be measured using high efficiency second harmonic (SH) scattering that directly measure the interfacial solvent redistributions. At the onset of aggregation (nucleation), there is an increase in the number of interfacial solvent molecules that leads to a steep increase in the SH intensity – this is used as a metric to measure the solubility limit.
Figure 1: Schematic of aggregation for the Solvent Redistribution method.
Automated High-Throughput Solubility Measurement Process
The full process of solubility measurement can be automated with liquid handling robots and the Solvent Redistribution method. (Figure 2) In step 1, an acoustic liquid dispenser (Labcyte, Echo platform) is used to directly transfer the stock solution into well-plates with increasing concentration. In step 2, the solvent is added with peristaltic liquid dispenser (typically 100 µL). Lastly, the well-plate is measured with the FASS instrument. The analysis is performed automatically using an integrated software.
Figure 2: Protocol for fully automated solubility measurement process
Work packages
WP 1
Prototype Development
Providing safe and easy-to-use instrumentation with reliable performance is a key requirement to attract customers. The team of WP1 will engineer a compact laboratory instrument with a new design that is compliant with regulations and ready for series production. The new TRL 6 demonstrator system will come with an improved optical and electronical design to boost performance and reliability and an integrated software package to satisfy the target market needs.
WP 2
Customer Development
To validate the value proposition of the FASS, the WP2 team will demonstrate the newly developed instrument to potential customer and compare the instrument to the market’s gold standard in a real user environment. Instruments can be visited via consortium partner and scientists from industry and academia can collaborate with us and measure their samples to experience the technology themselves.
WP 3
Business Development
Our research needs to translate into a viable product for the pharmaceutical industry. Our team develops and validates a business plan for the commercialization and go-to-market activities. We also ensure the protection of intellectual property rights, satisfy regulatory conditions and establish the supply chain for instrument production.
WP 4
Application Development
WP4 will identify value added applications of the FASS technology with a focus on the pharmaceutical profiling and early formulation development phase. This work package goes beyond aqueous drug solubility to study the solubilizing effects of excipients as well as to assess the technical feasibility of measurements in simulated intestinal fluids. Further analytical and computational modeling approaches will be applied to complement the analytics by second harmonics light scattering to broadly assess the pharmaceutical application potential of the novel FASS technology
WP 5
Coordination and Management
The key to deliver disruptive technology to the market is teamwork. The management WP facilitates an environment that allows a smooth interaction between partners to meet the project goals and to prepare important documents and reports to our funders.
WP 6
Dissemination and Communication
We do not work in the shadows. Our team sheds light on our activities and results for our target audience as well as the general public, across different channels and media.