Development of the world’s first universal liquid chromatography detector for pharmaceutical applications

高效液相色谱法是药物分析中使用最广泛的分析技术，其应用范围从检测药物制剂和生物液中的活性药物成分到质量控制和保证；例如，监测药物杂质和降解产物(Siddiqui，AlOthman和Rahman，2017)。根据这些组分通过色谱柱的不同速率，该样品被分成不同的组分。这种分离依赖于不同的极性、电荷或分子大小导致的柱保留的不同。分离出的成分从高效液相色谱柱上洗脱出来时就会被检测出来。制药和生物技术公司正在积极寻找一种定量的通用液相色谱检测器来检测与药物相关的分子。2021年10月，赋能技术联盟(阿斯利康、葛兰素史克和辉瑞等制药和生物技术公司的成员论坛)发布了一份征求建议书的请求。大多数高效液相检测器依靠UV/VIS光谱来检测和识别样品中的分析物，使紫外线和可见光穿过样品，并测量被吸收的光量。然而，UV/Vis光谱只能用于吸收紫外线或可见光的分析物，而定量检测依赖于知道每个分析物的吸收系数，并受溶剂吸收的影响。折射率检测虽然普遍响应，但灵敏度较低，不能用于梯度层析，因为改变溶剂组成会改变折射率。与等度洗脱相比，梯度层析具有更高的选择性、灵敏度和速度，被广泛应用于药物分析。更复杂的技术，如蒸发光散射检测(WIELS)、带电气溶胶检测(CAD)和质谱仪(MS)不适合半挥发性分析物，响应线性较差。APOHA正在开发世界上第一个用于制药应用的通用高效液相色谱检测器。我们的专利和专利新兴传感技术(由联合创始人兼实验物理学家Shamit Shriastava博士开发)通过监测任何分析物特有的属性(包括粘度、静电相互作用和表面张力)提供通用检测。在Innovate UK的支持下，我们将与排名前五的高效液相市场参与者一起，将我们的传感器技术从实验室验证阶段发展到原型系统演示。这将使我们准备好筹集后续私人融资，以实现项目后的快速商业化，在制药行业建立我们的技术。解决药物研发效率下降的问题，最终降低药物开发成本，提高药物的可负担性。

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.