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

高效液相色谱（HPLC）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体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）在HPLC中，将溶解在溶剂中的样品注入色谱柱中。根据这些组分通过色谱柱的不同速率，将该样品分离为单独的组分。这种分离依赖于不同极性、电荷或分子大小导致的柱保留差异。当分离的组分从HPLC柱中分离出来时，它们就被检测出来。制药和生物技术公司正在积极寻找一种用于药物相关分子的定量通用液相色谱检测器。赋能技术联盟（AstraZeneca、GlaxoSmithKline和Pfizer等成员制药和生物技术公司的论坛）于2021年10月发布了一项提案请求。大多数HPLC检测器依赖于UV/维斯光谱来检测和识别样品中的分析物，使紫外光和可见光穿过样品并测量被吸收的光量。然而，紫外/维斯光谱法只能用于吸收紫外或可见光的分析物，而定量检测依赖于知道每种分析物的吸收系数，并受溶剂吸光度的影响。折射率检测虽然普遍响应，但灵敏度差，不能与梯度色谱法一起使用，因为改变溶剂组成会改变折射率。与等度洗脱相比，梯度色谱具有更高的选择性、灵敏度和速度，因此用于药物分析。更复杂的技术，例如，蒸发光散射检测（ELDS）、荷电气溶胶检测（CAD）和质谱（MS）不适用于半挥发性分析物，且响应线性较差。Apoha正在开发世界上第一款用于制药应用的通用HPLC检测器。我们的专有和专利的新兴传感技术（由联合创始人和实验物理学家Shamit Shrivastava博士开发）通过监测任何分析物的独特特性（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，我们将开发我们的传感器技术，从实验室验证阶段到原型系统演示，与前5名HPLC市场参与者合作。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，从而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.