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制造高度生物治疗单克隆抗体的挑战和发展

Anurag S Rathore¹, Subhankar Metya², Rashmi Sharma²

¹School of Interdisciplinary Research, Indian Institute of Technology Delhi, New Delhi, India; Department of Chemical Engineering, Indian Institute of Technology Delhi, New Delhi, India.

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概括

高度单克隆抗体 (mAb) 配方为患者提供了方便,但也带来了制造方面的挑战. 本综述探讨了蛋白质-蛋白质相互作用,粘度,聚合和分析方法,用于高度mAb (HC-mAb) 的发展.

科学领域:

生物制药的发展.
蛋白质化学蛋白质化学
工艺工程是过程工程.

背景情况:

单克隆抗体 (mAbs) 是复杂疾病的有效生物治疗药物.
高度mAb (HC-mAb) 配方可进行皮下注射,提高了患者的便利性.
由于蛋白质与蛋白质相互作用的增加,HC-mAbs面临着聚合和高粘度等挑战.

研究的目的:

审查最近 (2019-2025) 在理解和解决HC-mAb配方和制造挑战方面的进展.
讨论蛋白质与蛋白质相互作用对HC-mAb溶液特性的影响.
分析后期制造业的障碍和分析性特征的作用.

主要方法:

文献综述侧重于过去五年 (2019-2025) 的发展情况.
对影响HC-mAb特性的蛋白质-蛋白质相互作用的分析.
讨论制造单位的操作 (例如超过/透过,填充/完成).
评估用于产品质量监测的先进分析技术.

主要成果:

蛋白质与蛋白质的相互作用显著改变HC-mAb溶液的特性,增加粘度和聚合风险.
晚期的制造工艺,如超过/透过和填充/完成,都会遇到HC-mAbs的挑战.
先进的分析表征对于在开发过程中监测HC-mAb质量至关重要.

结论:

管理粘度和聚合是成功的HC-mAb配方和制造的关键.
过程优化和强大的分析方法对于确保HC-mAbs.的质量和有效性至关重要.
对HC-mAb行为的持续研究对于推进生物治疗治疗至关重要.

关键词:

分析性表征分析性表征下游加工是下游加工.填充-完成操作.高度配制剂的制剂.单克隆抗体是一种单克隆抗体.蛋白质聚合蛋白质的聚合.溶液的粘度溶液的粘度超过/透过的方法

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