Hybridizing LBA with LC-MS/MS: the new norm for biologics quantification.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2016-02-26 DOI:10.4155/bio.16.9

S. Ramagiri, Ian Moore

引用次数: 23

Abstract

Over the past 20 years, protein and peptide drug development has advanced significantly, becoming a rapidly growing segment of the biotherapeutics market. It has generated treatments for a wide variety of diseases ranging from inflammatory disorders to cancer [1,2]. This expansion of biologics-based medicines has pushed drug manufacturers to adopt new bioanalytical and analytical approaches to quantify and characterize multiple modalities of protein-based therapeutics efficiently with particular focus on the highthroughput needs of early-stage PK studies. Ligand-binding assays (LBAs) are widely used for bioanalysis of small and large molecules, but these assays can be lengthy to develop and have limited selectivity and sensitivity. LC–MS/MS-based bioanalysis can offer important advantages over immunoassaybased techniques, but LC–MS/MS with large molecules introduces several challenges affecting throughput, operating expertise and ease of use.

查看原文本刊更多论文

LBA与LC-MS/MS杂交:生物制剂定量的新规范。

在过去的20年里，蛋白质和多肽药物的开发取得了显著进展，成为生物治疗市场中快速增长的一个部分。它产生了多种疾病的治疗方法，从炎症性疾病到癌症[1,2]。这种以生物制剂为基础的药物的扩展推动了药物制造商采用新的生物分析和分析方法，以有效地量化和表征基于蛋白质的治疗的多种模式，特别是关注早期PK研究的高通量需求。配体结合测定法(LBAs)广泛用于小分子和大分子的生物分析，但这些测定法可能需要很长时间才能开发出来，而且选择性和灵敏度有限。基于LC-MS /MS的生物分析与基于免疫分析的技术相比具有重要的优势，但是具有大分子的LC-MS /MS引入了一些影响吞吐量、操作专业知识和易用性的挑战。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.