摘要
本文深入剖析温度梯度形成机制对冻干速率与生物制品质量损失的影响,揭示其与疫苗质量的联系,探讨其对稳定性、活性及免疫原性的作用,并在此基础上设计基于温度梯度的调控策略理论框架及具体实施方法,包括调整冻干曲线和优化设备布局,通过模拟与验证预测及评估调控策略的效果。实际应用案例表明,调控策略在生物制品冻干过程中能够有效降低温度梯度,提高生物制品质量及稳定性。
In this paper,the formation mechanism of temperature gradient and its influence on freeze-drying rate and quality loss of biological products are deeply analyzed,and its relationship with vaccine quality is revealed,and its effect on stability,activity and immunogenicity is discussed.On this basis,the theoretical framework and specific implementation methods of control strategy based on temperature gradient are designed,including adjusting freeze-drying curve and optimizing equipment layout.Through simulation and verification,the effect of the regulation strategy is predicted and evaluated.The practical application case in this paper also shows that the control strategy can effectively reduce the temperature gradient and improve the quality and stability of biological products during the freeze-drying process.
作者
庞健
丁丽丽
梁小伟
张云
王军
PANG Jian;DING Lili;LIANG Xiaowei;ZHANG Yun;WANG Jun(Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou Gansu 730046)
出处
《中国科技纵横》
2025年第12期159-161,共3页
China Science & Technology Overview
关键词
生物制品冻干
温度梯度
质量损失
调控策略
freeze-drying of biological products
temperature gradient
quality loss
control strategy
