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长期研究配方缓冲器,以减轻关联关键试剂的稳定性问题

Glenn T Miller¹, Teresa M Caiazzo², Alison Joyce¹

¹Pfizer Inc., 1 Burtt Rd, Andover, MA 01810, United States of America.

Journal of immunological methods

|August 17, 2024

概括

配方缓冲器对于冷藏期间稳定生物治疗试剂至关重要. 一个新的蛋白质储存缓冲器有效地防止了聚合,并维持了关键试剂的性能,与PBS不同.

科学领域:

生物化学生物化学
生物技术是生物技术.
制药科学制药科学

背景情况:

关键试剂的稳定性对于生物治疗药物开发至关重要.
冷藏期间的蛋白质聚合可能会损害试剂的功能.
配方缓冲器可以减轻聚合问题.

研究的目的:

研究储存条件对结合生物治疗试剂稳定性的影响.
为了比较蛋白质储存缓冲器与PBS在防止聚合方面的有效性.
评估聚合对试剂性能的功能影响.

主要方法:

用生物素,和Alexa Fluor 647标记的小鼠单克隆抗体 (mAb) 和人类多种药物在-80°C下存储3-15个月.
样品被储存在PBS或蛋白质储存缓冲区中.
分析了生物物理属性 (聚合) 和功能属性 (联结).

主要成果:

在4个月后在PBS中储存的mAb合物中观察到聚合,导致沉和结合减少15个月.
药物合物随着时间的推移在PBS中呈现增加的聚合,但功能性能保持不变.
在任何一个缓冲区中都没有观察到生物标记试剂的聚合或性能问题.
与PBS相比,蛋白质储存缓冲器对聚合的保护性更强.

结论:

配方缓冲剂的选择显著影响结合生物治疗试剂的长期稳定性.
专门的蛋白质储存缓冲器在长时间冷藏期间有效地保持关键试剂的完整性和功能.
这些发现对于在生物治疗药物开发中确保连接体结合试验的可靠性至关重要.

关键词:

标志性描述标志性描述结合方式结合方式关键试剂关键试剂配方缓冲器中的配方缓冲器稳定的稳定性稳定的稳定性

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