了解Polysorbate-20对治疗性蛋白质中无菌过器的吸附行为,最终的过过程
Jian Ren1, Yun Zhang2, Chen Wang2
1Purification Development, Operations Science & Technology, AbbVie Bioresearch Center, Worcester, Massachusetts, USA.
Biotechnology progress
|November 21, 2023
概括
聚酸-20 (PS-20) 在治疗性蛋白质制造过程中可以吸附到无菌过器上. 这项研究量化了微过膜上的PS-20吸附,以优化过器选择和预冲洗策略,以获得稳定的药物制品配方.
科学领域:
- 生物制药制造业 生物制药制造业
- 蛋白质稳定 蛋白质稳定
- 过技术过技术的使用
背景情况:
- 像聚酸-20 (PS-20) 这样的表面活性剂对于稳定治疗性蛋白质和防止聚合至关重要.
- 无菌过是生物制药制造中的关键步骤,但聚酸盐对过器的吸附可以降低其在最终产品中的度.
- 确保一致的PS-20水平对于基于蛋白质的治疗方法的有效性和安全性至关重要.
研究的目的:
- 调查和量化聚酸盐-20 (PS-20) 在常见的灭菌级微过膜 (MF) 上的吸附行为.
- 评估各种膜性质 (材料,修饰,层配置) 和PS-20度对吸附的影响.
- 为选择无菌过器和优化预冲洗策略提供数据驱动的建议,以保持治疗性蛋白质药物产品中精确的PS-20度.
主要方法:
- 利用定制的过设置来评估PS-20在不同MF膜上的吸附.
- 系统地改变了膜特性和PS-20度,以研究吸附动力学.
- 对每个膜类型量化确定PS-20吸附量,并与工艺观察进行比较.
主要成果:
- 在常用的灭菌级微过膜上显示出显著的PS-20吸附.
- 量化了吸附水平,显示实验数据和工艺吸附之间的良好一致性.
- 确定了影响PS-20吸附程度的特定膜特性.
结论:
- 膜性质在无菌过过程中显著影响聚酸-20的吸附.
- 对吸附的定量评估对于预测和控制最终药物产品中PS-20度至关重要.
- 优化无菌过器选择和洗前协议是必要的,以减轻PS-20的损失,并确保治疗性蛋白质配方的稳定性.
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