Addressing endotoxin issues in bioengineered heparin.
Addressing endotoxin issues in bioengineered heparin.
复制标题
解决生物工程肝素中的内毒素问题。
DOI：
10.1002/bab.1042
复制
发表时间：
2012
影响因子：
2.8
通讯作者：
Linhardt,RobertJ
中科院分区：
文献类型：
--
作者：
Suwan,Jiraporn;Torelli,Amanda;Onishi,Akihiro;Dordick,JonathanS;Linhardt,RobertJ
肝素是一种广泛应用于临床的抗凝剂，主要由猪肠制备而成。2008年的肝素污染导致了对动物源性药物的重新检查。目前正在开发通过细菌发酵和化学及酶处理制备的生物工程肝素。本研究探讨了减少或去除与该工艺相关的内毒素的挑战，这些内毒素是进行生物工程肝素临床前体内评价所必需的。评估当前工艺的内毒素水平，并检查从该工艺中涉及的多糖和酶中去除内毒素的策略。
Heparin is a widely used clinical anticoagulant that is prepared from pig intestine. A contamination of heparin in 2008 has led to a reexamination of animal‐derived pharmaceuticals. A bioengineered heparin prepared by bacterial fermentation and chemical and enzymatic processing is currently under development. This study examines the challenges of reducing or removing endotoxins associated with this process that are necessary to proceed with preclinicalin vivoevaluation of bioengineered heparin. The current process is assessed for endotoxin levels, and strategies are examined for endotoxin removal from polysaccharides and enzymes involved in this process.