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引用次数: 0
摘要
导言:制药业不断扩大对创新生物疗法的探索。此类疗法的全面表征需要多种分析技术来全面评估关键的质量属性,这使得分析成为发现和开发时限的瓶颈。尽管全面的表征对于确保生物治疗药物的安全性和有效性至关重要,但仍有必要进一步简化分析表征,加快从发现到上市的整个时间进程:本综述重点介绍液相分离与离子迁移质谱联用技术(IM-MS)在生物治疗药物开发与表征方面的最新进展。我们将介绍如何利用 IM-MS 改进单克隆抗体、抗体药物共轭物、宿主细胞蛋白质、聚糖和核酸的表征。本讨论基于使用 Web of Science、Google Scholar 和 SciFinder 进行的广泛文献检索:IM-MS 有可能提高生物治疗特性分析的深度和效率,因为它能提供更多有关构象变化、翻译后修饰和杂质概况的信息。IM-MS 具有快速的时间尺度,通过与生物制药分析中常用的标准液相分离技术的简便集成,IM-MS 可以很好地提高现有检测方法的信息含量。
Liquid-phase separations coupled with ion mobility-mass spectrometry for next-generation biopharmaceutical analysis.
Introduction: The pharmaceutical industry continues to expand its search for innovative biotherapeutics. The comprehensive characterization of such therapeutics requires many analytical techniques to fully evaluate critical quality attributes, making analysis a bottleneck in discovery and development timelines. While thorough characterization is crucial for ensuring the safety and efficacy of biotherapeutics, there is a need to further streamline analytical characterization and expedite the overall timeline from discovery to market.
Areas covered: This review focuses on recent developments in liquid-phase separations coupled with ion mobility-mass spectrometry (IM-MS) for the development and characterization of biotherapeutics. We cover uses of IM-MS to improve the characterization of monoclonal antibodies, antibody-drug conjugates, host cell proteins, glycans, and nucleic acids. This discussion is based on an extensive literature search using Web of Science, Google Scholar, and SciFinder.
Expert opinion: IM-MS has the potential to enhance the depth and efficiency of biotherapeutic characterization by providing additional insights into conformational changes, post-translational modifications, and impurity profiles. The rapid timescale of IM-MS positions it well to enhance the information content of existing assays through its facile integration with standard liquid-phase separation techniques that are commonly used for biopharmaceutical analysis.
期刊介绍:
Expert Review of Proteomics (ISSN 1478-9450) seeks to collect together technologies, methods and discoveries from the field of proteomics to advance scientific understanding of the many varied roles protein expression plays in human health and disease.
The journal coverage includes, but is not limited to, overviews of specific technological advances in the development of protein arrays, interaction maps, data archives and biological assays, performance of new technologies and prospects for future drug discovery.
The journal adopts the unique Expert Review article format, offering a complete overview of current thinking in a key technology area, research or clinical practice, augmented by the following sections:
Expert Opinion - a personal view on the most effective or promising strategies and a clear perspective of future prospects within a realistic timescale
Article highlights - an executive summary cutting to the author''s most critical points.