Tortajada-Genaro Luis Antonio
Instituto Interuniversitario de Investigación de Reconocimiento Molecular y Desarrollo Tecnológico (IDM), Universitat Politècnica de València, Universitat de València, Camino de Vera s/n, E46022 Valencia, Spain.
Departamento de Química, Universitat Politècnica de València, Camino de Vera s/n, E46022 Valencia, Spain.
Biosensors (Basel). 2024 Dec 13;14(12):615. doi: 10.3390/bios14120615.
(1) Background: In drug discovery and pharmaceutical quality control, a challenge is to assess protein extracts used for allergy therapy and in vivo diagnosis, such as prick tests. Indeed, there are significant differences between the features of marketed products due to variations in raw materials, purification processes, and formulation techniques. (2) Methods: A protein array technology has been developed to provide comprehensive information on protein-biomarker interactions on a large scale to support the pharmaceutical industry and clinical research. The biosensing method is based on immobilizing low volumes of protein extracts (40 nL) on thermoplastic chips in array format. The biological activity was estimated by incubating with serum from representative food allergy patients. (3) Results: The reproducible optical signals were registered (deviation lower than 10%) using low-cost technologies such as a smartphone and a reader of digital versatile discs. The method was applied to pharmaceutical products to diagnose ten common food allergies, including barley, kiwi, milk, prawn, egg, peanut, wheat, peach, walnut, and squid. Quality indicators were established from spot intensities, enabling an effective comparison of manufacturers. (4) Conclusions: A biosensing-based strategy for screening pharmaceutical products emerges as a reliable and advantageous alternative to traditional approaches such as electrophoresis, fluorescence chips, and ELISA assays. This high-throughput method can contribute to understanding complex biological processes and evaluate the performance of pharmaceutical products.
(1) 背景：在药物研发和药品质量控制中，一项挑战是评估用于过敏治疗和体内诊断的蛋白质提取物，如点刺试验。事实上，由于原材料、纯化工艺和制剂技术的差异，市售产品的特性存在显著差异。(2) 方法：已开发出一种蛋白质阵列技术，以大规模提供有关蛋白质 - 生物标志物相互作用的全面信息，以支持制药行业和临床研究。该生物传感方法基于将少量蛋白质提取物（40 nL）以阵列形式固定在热塑性芯片上。通过与代表性食物过敏患者的血清孵育来估计生物活性。(3) 结果：使用低成本技术，如智能手机和数字多功能光盘读取器，记录了可重复的光学信号（偏差低于10%）。该方法应用于药品，以诊断十种常见食物过敏，包括大麦、猕猴桃、牛奶、虾、鸡蛋、花生、小麦、桃子、核桃和鱿鱼。根据斑点强度建立了质量指标，从而能够对制造商进行有效比较。(4) 结论：一种基于生物传感的药品筛选策略成为一种可靠且优于传统方法（如电泳、荧光芯片和ELISA检测）的替代方法。这种高通量方法有助于理解复杂的生物过程并评估药品的性能。
