Title: Development of the world’s first universal liquid chromatography detector for pharmaceutical applications
Funder: Innovate UK

Abstract: High-performance liquid chromatography (HPLC) is the most widely used analytical technique in pharmaceutical analysis, with applications spanning from detection of active pharmaceutical ingredients in drug formulations and biological fluids to quality control and assurance; for example, monitoring pharmaceutical impurities and degradation products (Siddiqui, AlOthman, and Rahman, 2017). In HPLC, a sample dissolved in a solvent is injected into a column. This sample is separated into its individual components based on the different rates at which these components travel through the column. This separation relies on differences in column retention resulting from varying polarity, electrical charge, or molecular size. The separated components are detected as they elute from the HPLC column. Pharmaceutical and biotechnology companies are actively searching for a quantitative universal liquid chromatography detector for pharmaceutically relevant molecules. The Enabling Technologies Consortium (a forum for member pharmaceutical and biotechnologies companies including AstraZeneca, GlaxoSmithKline, and Pfizer) issued a request for proposals in October 2021\. Most HPLC detectors rely on UV/vis spectroscopy to detect and identify analytes in the sample, passing ultraviolet and visible light through the sample and measuring the amount of light that is absorbed. However, UV/vis spectroscopy can only be used with analytes that absorb ultraviolet or visible light, while quantitative detection relies on knowing the absorption coefficient of each analyte and is affected by solvent absorbance. Refractive index detection, while universally responsive, suffers from poor sensitivity and cannot be used with gradient chromatography, since changing solvent composition alters refractive index. Gradient chromatography is used for pharmaceutical analysis because of its higher selectivity, sensitivity, and speed compared to isocratic elution. More sophisticated techniques e.g., Evaporative Light Scattering Detection (ELDS), Charged Aerosol Detection (CAD), and Mass Spectrometry (MS) are unsuitable for semi-volatile analytes and provide poor response linearity. Apoha is developing the world's first universal HPLC detector for pharmaceutical applications. Our proprietary and patented emerging sensing technology (developed by cofounder and experimental physicist Dr Shamit Shrivastava) provides universal detection by monitoring properties that are unique to any analyte (including viscosity, electrostatic interaction, and surface tension). With Innovate UK support, we will develop our sensor technology from laboratory validation stage to prototype system demonstration with a top 5 HPLC market player. This will position us ready to raise follow-on private finance for rapid post-project commercialisation, establishing our technology in the pharmaceutical industry. Addressing declining pharmaceutical R&D efficiency and ultimately lowering the cost of drug development and enhancing pharmaceutical affordability.


Research activity codes: 5.1 PHARMACEUTICALS
Health categories: GENERIC HEALTH RELEVANCE