Lee Dong Hun, Xie Iris, Solomon Matthew, Wang Ming, Luo Linlin, Woolf Eric
Merck & Co., Inc., Regulated Bioanalytics, 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA.
AAPS J. 2025 Apr 29;27(4):84. doi: 10.1208/s12248-025-01040-x.
Experiments designed to assess the ability to analyze Volumetric Absorptive Microsampling (VAMS) or Tasso-M20 dried blood samples using ligand binding assays to support pharmacokinetic studies are described. An internally developed monoclonal antibody therapeutic A (mAb A) was employed as a model compound to facilitate this evaluation. The challenges of daily preparation of VAMS calibrators in wet blood and the identification of a suitable diluent for use with dried blood samples at high analyte concentrations were addressed. A suitable surrogate matrix solution was identified for constructing calibrators, enabling accurate quantitation from dried blood samples. Additionally, utilizing surrogate matrix solutions as a diluent confirmed the absence of bias in the quantitation of diluted samples. The results of this feasibility study demonstrate the potential of using a surrogate matrix solution to address challenges associated with the analysis of dried blood samples via ligand binding methodology.
描述了旨在评估使用配体结合测定法分析体积吸收微采样（VAMS）或Tasso-M20干血样本以支持药代动力学研究的能力的实验。使用内部开发的单克隆抗体治疗药物A（mAb A）作为模型化合物来促进该评估。解决了在湿血中每日制备VAMS校准物的挑战以及鉴定适用于高分析物浓度干血样本的稀释剂的问题。确定了一种合适的替代基质溶液用于构建校准物，从而能够从干血样本中进行准确定量。此外，使用替代基质溶液作为稀释剂证实了稀释样本定量中不存在偏差。这项可行性研究的结果证明了使用替代基质溶液来解决通过配体结合方法分析干血样本相关挑战的潜力。
