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采用体积吸收微采样技术评估单克隆抗体治疗药物的全血稳定性。

Whole blood stability evaluation of monoclonal antibody therapeutics using volumetric absorptive microsampling.

机构信息

Biotherapeutics Discovery, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield CT 06877, USA.

出版信息

Bioanalysis. 2021 Apr;13(8):621-629. doi: 10.4155/bio-2021-0025. Epub 2021 Apr 8.

Abstract

Volumetric absorptive microsampling (VAMS) is increasingly utilized for both nonclinical and clinical pharmacokinetic studies. Currently, VAMS is employed as the sampling method for the detection of antibodies for coronavirus disease 2019. Biotherapeutics whole blood stability on VAMS presents as a critical concern for the health and pharmaceutical industries. In this follow-up to our previous publication, we evaluated daclizumab and trastuzumab whole blood sample stability on VAMS. The drug recovery data we observed at room temperature for short term and -80°C for long term was very encouraging. The knowledge could help us better understand and plan important investigation timelines, especially pandemic situations where human whole blood samples from a large population are collected and in urgent need of data analysis.

摘要

体积吸收微采样(VAMS)越来越多地用于非临床和临床药代动力学研究。目前,VAMS 被用作检测 2019 年冠状病毒病抗体的采样方法。生物治疗药物在 VAMS 上的全血稳定性是医疗和制药行业的一个关键关注点。在我们之前的出版物的后续研究中,我们评估了达珠单抗和曲妥珠单抗在 VAMS 上的全血样本稳定性。我们观察到的室温短期和-80°C 长期药物回收率数据非常令人鼓舞。这些知识可以帮助我们更好地理解和规划重要的研究时间线,特别是在大人群中采集人类全血样本并急需数据分析的大流行情况下。

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