对单克隆抗体的持续下游处理量化过程分析技术的审查
Mariana Carvalho1, Ana Cruz2, Cees Haringa1
1Department of Biotechnology, Delft University of Technology, Delft, The Netherlands.
Biotechnology and bioengineering
|December 26, 2025
概括
连续制造提供了减少生物制药生产时间和成本. 过程分析技术可以实时控制单克隆抗体的质量,提高效率和产品安全.
科学领域:
- 生物制药制造业 生物制药制造业
- 过程分析技术 过程分析技术
- 分析化学 分析化学
背景情况:
- 生物制药市场竞争日益激烈,需要具有成本效益和高效的生产方法.
- 不断上升的研发成本推动了创新制造战略的需求.
- 生物类似产品进入市场加剧了竞争,要求提高生产经济性.
研究的目的:
- 审查用于单克隆抗体表征的最先进的定量实时分析技术.
- 突出过程分析技术 (PAT) 在连续下游生物制造中的机会.
- 探索PAT在减少生产周期时间和成本方面的好处.
主要方法:
- 关于PAT在生物制药制造中的当前应用的文献综述.
- 实时分析技术的评估,用于过程中控制和质量测量.
- 对单克隆抗体的持续下游加工PAT实施的分析.
主要成果:
- 连续制造为减少生产周期时间和成本提供了巨大的潜力.
- 过程分析技术 (PAT) 允许实地实时测试,取代传统的批量测试.
- 积极的监测和控制系统对于在连续过程中的定量产品质量测量至关重要.
结论:
- 过程分析技术 (PAT) 是一种可靠的实时分析策略,用于连续生物制造.
- 定量实时分析技术对于在连续下游过程中表征单克隆抗体至关重要.
- 未来的机会存在于推进PAT,以提高生物制药生产的效率和质量控制.
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