Gyros Protein Technologies AB, Uppsala, Sweden.
Methods Mol Biol. 2023;2612:109-127. doi: 10.1007/978-1-0716-2903-1_9.
Gyrolab is an open immunoassay platform that automates the complete immunoassay protocol in a microfluidic disc. The column profiles generated with Gyrolab immunoassays are used to gain more information about biomolecular interactions that can be useful in assay development or quantify analytes in samples. Gyrolab immunoassays can be used to cover a broad concentration range and diversity of matrices in applications ranging from biomarker monitoring, pharmacodynamics and pharmacokinetics studies, to bioprocess development in many areas, including therapeutic antibodies, vaccines, and cell and gene therapy.This chapter is an overview of Gyrolab technology, including system components and the assay development workflow, including the process of selecting affinity reagents, Gyrolab Bioaffy CDs, and assay conditions to optimize immunoassays. Two case studies are included. The first involves an assay for the humanized antibody pembrolizumab used in cancer immunotherapy that can generate data for pharmacokinetics studies. The second case study involves quantification of the biomarker and biotherapeutic interleukin-2 (IL-2) in human serum and buffer. IL-2 has been implicated in the cytokine storm associated with COVID-19, and cytokine release syndrome (CRS), which can occur during chimeric antigen receptor T cell (CART) therapy used in treating cancer. These molecules also have therapeutic relevance in combination.
Gyrolab 是一种开放式免疫分析平台，可在微流控盘中自动完成完整的免疫分析方案。Gyrolab 免疫分析生成的柱形图可用于获取更多关于生物分子相互作用的信息，这些信息可用于在分析开发或定量样本中的分析物中发挥作用。Gyrolab 免疫分析可用于涵盖广泛的浓度范围和基质多样性，应用领域包括生物标志物监测、药效动力学和药代动力学研究，以及许多领域的生物工艺开发，包括治疗性抗体、疫苗和细胞和基因治疗。
本章概述了 Gyrolab 技术，包括系统组件和分析开发工作流程，包括选择亲和试剂、Gyrolab Bioaffy CD 和优化免疫分析的分析条件的过程。包括两个案例研究。第一个涉及用于癌症免疫治疗的人源化抗体 pembrolizumab 的分析，可生成用于药代动力学研究的数据。第二个案例研究涉及在人血清和缓冲液中定量生物标志物和生物治疗性白细胞介素-2（IL-2）。IL-2 与 COVID-19 相关的细胞因子风暴和嵌合抗原受体 T 细胞（CART）治疗中发生的细胞因子释放综合征（CRS）有关，该治疗用于治疗癌症。这些分子在联合治疗中也具有治疗相关性。
