用于抗体纯化工艺中除病毒膜的应用研究进展

Research Progress on the Application of Virus Removal Membranes in Antibody Purification Processes

抗体类药物被作为治疗制剂、血液制品和免疫调节剂等,正成为生物医药领域的研究前沿。在抗体下游纯化工艺中常使用除病毒膜去除病毒颗粒,它保障了抗体类药物的卫生安全和患者的生命健康。本文综述了目前病毒过滤的分离机理以及除病毒膜的新型材料研究,对市售的除病毒过滤器性能参数简述概括,对膜技术应用于病毒过滤的挑战和困难进行了总结和展望。

Antibody-based drugs,used as therapeutic agents,blood products,and immunomodulators,are becoming a frontier in the biopharmaceutical field.In the downstream purification processes of antibodies,virus removal membranes are commonly employed to eliminate viral particles,ensuring the hygienic safety of antibody-based drugs and the health of patients.This review summarizes the current separation mechanisms of virus filtration and the research on novel materials for virus removal membranes.It also provides an overview of the performance parameters of commercially available virus removal filters and discusses the challenges and difficulties associated with applying membrane technology to virus filtration,along with future prospects.