工艺与制造英文2020被引 1
治疗性蛋白制剂无菌过滤工艺的基础研究
Basic studies for sterile filtration processing of therapeutic protein formulations
Susanne Haindl
摘要整理
本研究系统调查了蛋白质制剂的过滤灭菌工艺。重点考察了工艺条件(如温度)对滤膜污堵、蛋白质吸附以及过滤工艺放大的影响。研究通过改变温度等关键参数,评估了过滤过程中滤膜的污堵机制和蛋白质分子在滤膜表面的吸附行为,为治疗性蛋白制剂的无菌过滤工艺优化和工业化放大提供了基础数据支撑。该研究对于确保蛋白质药物的无菌性、保持蛋白质活性和提高生产效率具有重要意义。
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