多维技术 - - 生物治疗特征的最新进展和应用
Thomas Bouvarel1, Julien Camperi2, Davy Guillarme3,4
1Protein Analytical Chemistry, Genentech, South San Francisco, California, USA.
Journal of separation science
|March 12, 2024
概括
多维液态染色学-质谱学 (mD-LC-MS) 正在为复杂的产品成熟. 在线工作流提高了效率,减少了工件,为实时生物制药质量监测铺平了道路.
科学领域:
- 分析化学 分析化学
- 生物化学 生物化学
- 生物技术是生物技术.
背景情况:
- 多维液态色谱与质谱学 (mD-LC-MS) 结合,已经有了显著的进化.
- 传统的离线工作流程在样本处理和分析时间方面存在挑战.
研究的目的:
- 审查MD-LC-MS的最新进展和应用.
- 探索MD-LC-MS作为一个过程分析技术 (PAT) 工具的潜力.
- 确定该领域的新兴趋势和未来方向.
主要方法:
- 目前文献和实验室间研究的综述.
- 分析工作流的改进,包括从离线转向在线的转变. mD-LC-MS.
- 讨论复杂产品分析和生物制药监测中的应用.
主要成果:
- 在线mD-LC-MS工作流程减少了文物,变化和分析时间.
- 该技术已经成熟,适用于各种复杂的产品应用.
- 存在实时监测单克隆抗体质量的潜力.
结论:
- mD-LC-MS是一种强大的技术,用于表征复杂的产品.
- 新兴趋势包括新模式,生物活动评估和毛细管电泳替代方案.
- mD-LC-MS 准备为生物制药品塑造下一代分析工具.
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