新兴药物模式的分析技术的进步及其在LC-MS系统中的分离挑战
M Malarvannan1, V Ravichandiran1, David Paul1
1Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Maniktala, Kolkata, West Bengal 700054, India.
Journal of chromatography. A
|August 7, 2024
概括
分析复杂的生物疗法需要先进的生物分析方法. 本综述详细介绍了液态染色体质谱法 (LC-MS) 技术,用于新型模式,如抗体-药物合物和基因疗法.
科学领域:
- 生物化学 生物化学
- 分析化学 分析化学
- 药理学 药理学是指药理学的学科.
背景情况:
- 新型生物治疗药物的发展,包括基因疗法,寡核酸,抗体-药物合物,单克隆抗体和PROTACs,带来了重大的生物分析挑战.
- 量化这些复杂的分子结构对于临床前和临床研究至关重要,以指导治疗开发.
- 现有的生物分析方法,特别是液态染色体质谱法 (LC-MS) 技术,在精确测量这些复杂且往往低度的模式方面遇到了困难.
研究的目的:
- 审查和分类新的生物治疗方法.
- 讨论当前的生物分析策略和样本准备技术,以使用LC-MS分析这些新的模式.
- 评估各种基于LC-MS的技术的优缺点,并探索该领域的未来前景.
主要方法:
- 对新型生物治疗药物的现有和新兴生物分析策略的文献评论.
- 对各种基于LC-MS的方法进行分析,包括AEX-HPLC-MS,RP-IP-LCMS,HILIC-MS,LCHRMS,Microflow-LC-MS,ASMS和混合LBA/LC-MS.
- 讨论样品制备技术及其对复杂生物疗法分析的影响.
主要成果:
- 对新型模式及其分类的全面概述.
- 详细研究生物制药分析的各种LC-MS技术的应用,优势和局限性.
- 识别正在进行的挑战和改进策略,开发基于LC-MS的强大方法.
结论:
- 开发基于LC-MS的复杂方法和熟练的人员对于分析复杂的生物疗法至关重要.
- 为了克服当前的分析障碍,LC-MS技术的不断进步是必要的.
- 本综述为生物制药开发中的生物分析策略提供了当前景观和未来方向的见解.
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