计算机辅助多因素方法开发,用于在 (生物) 制药环境中简化分离和分析多成分混合物
Mohamed Hemida1, Imad A Haidar Ahmad1, Rodell C Barrientos1
1Analytical Research and Development, MRL, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, NJ, 07065, United States.
Analytica chimica acta
|February 8, 2024
概括
计算机辅助色谱法开发加速了复杂生物制药的分析. 这种方法简化了工作流程,提高了生产力,降低了治疗分析的成本.
科学领域:
- 分析化学 分析化学
- 生物制药学分析
- 染色学科学 染色学科学
背景情况:
- 生物制药行业面临的挑战是复杂的药物模式,需要先进的分析技术.
- 手动和不系统的方法开发阻碍了新兴治疗方法的高效测试部署.
研究的目的:
- 审查生物制药特征和净化计算机辅助多因素染色学方法开发策略.
- 强调数字化和自动化在简化分析工作流程中的作用.
主要方法:
- 讨论各种色谱技术:逆相液态色谱 (RPLC),水友相互作用液态色谱 (HILIC),离子交换色谱 (IEX),疏水性相互作用色谱 (HIC) 和超临界流体色谱 (SFC).
- 对保留机制建模和隔离景观绘制的关键参数的分析.
- 计算机辅助优化方法的概述,包括线性,非线性和多因素建模.
主要成果:
- 用计算机辅助的策略来优化色谱选择性和分辨率的演示.
- 实质性提高生产率和节省成本的说明.
- 加快治疗分析的方法开发,部署和转移流程.
结论:
- 计算机辅助色谱方法的开发对于高效的生物制药分析至关重要.
- 数字化和自动化在工业环境中显著提高生产率并降低成本.
- 这些策略使复杂药物模式的表征和净化速度更快.
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