治疗性蛋白质浓缩物中的病毒灭活/去除

Virus inactivation/elimination in therapeutic protein concentrates.

作者信息

Mitra G, Dobkin M B, Wong M F, Mozen M M

机构信息

Biological Research and Development, Cutter Biological, Miles Inc., Berkeley, Calif.

出版信息

Curr Stud Hematol Blood Transfus. 1989(56):34-43. doi: 10.1159/000416555.

DOI:10.1159/000416555

PMID:2910652

Abstract

Concern for virus transmission from intravenous biological products, derived from natural and biotechnological sources, has prompted us to investigate various methods for virus inactivation while preserving the biological activity of the therapeutic entity. This concern is currently acute regarding the presence of HIV in purified human plasma protein concentrates. Four different methods of virus removal (1) heating in solution; (2) use of lipid solvents; (3) low pH treatment, and (4) partitioning during purification, are reported for various plasma proteins that have been spiked with model viruses. General virus inactivation strategies for therapeutic protein concentrates are discussed.

摘要

对源自天然和生物技术来源的静脉注射生物制品病毒传播的担忧，促使我们研究各种病毒灭活方法，同时保留治疗实体的生物活性。目前，对于纯化的人血浆蛋白浓缩物中存在HIV的担忧尤为突出。本文报道了四种不同的病毒去除方法：（1）溶液加热；（2）使用脂质溶剂；（3）低pH处理；（4）纯化过程中的分配，用于添加了模型病毒的各种血浆蛋白。并讨论了治疗性蛋白浓缩物的一般病毒灭活策略。