Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-02-01 Epub Date: 2023-12-13 DOI:10.4155/bio-2023-0179

Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer

引用次数: 0

Abstract

Antibody therapeutic levels in neurodegenerative diseases are often measured in both serum and cerebrospinal fluid (CSF). Due to 0.1% drug partition from serum to CSF and the higher sensitivity needs, usually two different assays are required. The different Gyrolab Bioaffy compact discs can extend the dynamic range of assays. Here, an assay was developed and adapted on two different Gyrolab Bioaffy compact discs (200 and 4000 nl) to achieve the required sensitivity and assay dynamic range needed for the measurement of drug in both serum and CSF. This was accomplished by using the same critical reagents with minimal assay development to transition from a serum to a CSF assay.

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扩大检测范围，以适应血液和脑脊液中单克隆抗体的治疗定量。

神经退行性疾病的抗体治疗水平通常在血清和脑脊液（CSF）中同时测定。由于从血清到 CSF 的药物分配率为 0.1%，而且灵敏度要求较高，因此通常需要两种不同的检测方法。不同的 Gyrolab Bioaffy 光盘可以扩大检测的动态范围。在此，我们在两种不同的 Gyrolab Bioaffy 光盘（200 nl 和 4000 nl）上开发并调整了一种检测方法，以达到测量血清和 CSF 中药物所需的灵敏度和检测动态范围。这是通过使用相同的关键试剂实现的，从血清到脑脊液检测只需进行最少的检测开发。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.