一次性搅拌系统均一性研究  

Research on Uniformity of Disposable Mixing System

作　　者：张薇 Zhang Wei(Shenzhen Kangtai Biological Products Co.,Ltd.,Shenzhen,Guangdong 518057)

机构地区：[1]深圳康泰生物制品股份有限公司,广东深圳518057

出　　处：《现代工程科技》2024年第20期105-108,共4页Modern Engineering Technology

摘　　要：探究一次性搅拌系统在生物制药工艺中的应用,旨在通过优化搅拌系统参数提高佐剂重悬的均一性,从而提升疫苗等生物制品的质量控制和生产效率。在一次性搅拌系统中选定6个取样位点,包括表面、底部等部位,设计实验将佐剂原液在一次性搅拌系统中稀释至不同浓度,在不同搅拌重量、不同搅拌转速、不同搅拌时间下取样检测铝含量,分析各参数对铝含量均一性的影响,确定最优参数组合。研究表明,200 L一次性搅拌系统在搅拌重量为200 kg、转速为150 rpm、搅拌时间为15 min的条件下,铝佐剂的重悬达到了较高的均一性水平;500 L一次性搅拌系统在搅拌重量为500 kg、转速为150 rpm、搅拌时间10 min的条件下,铝佐剂的重悬也可以达到较高的均一性水平。相较于其他测试条件,该参数组合显著降低了样品间的变异系数。建议在生物制药生产中采用这一参数配置,以实现更高效、更一致的生产流程。未来工作可进一步探索不同规模生产条件下该参数的普适性及长期稳定性测试。Exploring the application of disposable stirring systems in biopharmaceutical processes aims to improve the uniformity of adjuvant resuspension by optimizing stirring system parameters,thereby enhancing the quality control and production efficiency of biological products such as vaccines.Six sampling sites were selected in the disposable stirring system,including the surface,bottom,and other parts.An experiment was designed to dilute the adjuvant solution to different concentrations in the disposable stirring system.Aluminum content was measured by sampling at different stirring weights,stirring speeds,and stirring times.The influence of various parameters on the uniformity of aluminum content was analyzed to determine the optimal parameter combination.Research has shown that under the conditions of a stirring weight of 200 kg,a rotation speed of 150 rpm,and a stirring time of 15 min,a 200 L disposable stirring system achieves a high level of uniformity in the resuspension of aluminum adjuvant.Similarly,under the conditions of a stirring weight of 500 kg,a rotation speed of 150 rpm,and a stirring time of 10 min,a 500 L disposable stirring system can also achieve a high level of uniformity in the resuspension of aluminum adjuvant.Compared to other testing conditions,this parameter combination significantly reduces the coefficient of variation between samples.It is recommended to adopt this parameter configuration in biopharmaceutical production to achieve a more efficient and consistent production process.Future work can further explore the universality and long-term stability testing of this parameter under different scale production conditions.

关 键 词：铝佐剂 一次性搅拌系统 均一性 

分 类 号：TU646[建筑科学—建筑技术科学]