对进行重组单克隆抗体生物相似物分析和功能生物相似性评估的最佳实践
Anurag S Rathore1,2, Raj Suryanarayanan3,4, Reza Nejadnik3,5
1Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, Delhi, New Delhi, 110016, India. asrathore@biotechcmz.com.
The AAPS journal
|February 18, 2026
概括
生物类似药提供有效的治疗,副作用较低,但成本昂贵. 证明单克隆抗体 (mAbs) 的生物相似性涉及分析挑战,特别是在辅助剂方面,这会影响稳定性和评估结果.
科学领域:
- 生物制药开发 生物制药开发
- 分析化学 分析化学
- 监管科学 监管科学
背景情况:
- 生物治疗药物比小分子具有更高的疗效和安全性,但成本更高,限制了可访问性.
- 生物类似药,与已批准的参考产品非常相似,旨在提高这些先进疗法的可负担性和获取性.
- 证明生物相似性需要广泛的分析表征,这是获得监管批准的关键步骤.
研究的目的:
- 识别和讨论显示单克隆抗体 (mAb) 产品生物相似性的挑战.
- 具体解决助剂对mAb生物相似性评估的影响,包括产品稳定性和分析结果.
- 为生物类似药制造商提供最佳实践,以应对在mAb配方中的辅助剂相关挑战.
主要方法:
- 使用正交的高分辨率技术进行全面的分析表征.
- 案例研究研究了辅助剂去除对产品稳定性的影响.
- 在生物相似性评估中使用的常见分析和功能测定对辅助剂影响的评估.
主要成果:
- 助剂可以显著影响单克隆抗体 (mAb) 产品的稳定性.
- 辅助剂的存在可以改变用于生物相似性评估的各种分析和功能工具所获得的结果.
- 了解这些影响对于准确的生物相似性评估至关重要.
结论:
- 成功证明mAbs的生物相似性需要仔细考虑助剂对分析和功能评估的影响.
- 对辅助剂管理的最佳实践对于生物类似药制造商来说至关重要,以克服表征挑战.
- 对于批量编号,验收标准和直角方法的战略方法对于监管批准至关重要.
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