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Cygnus technologies

品牌:Cygnus technologies    国家:美国    网址:http://www.cygnustechnologies.com

Cygnus technologies品牌介绍

美国 Cygnus technologies,专业生产用于检测生物制品基因工程药物中的宿主蛋白及DNA残留检测试剂盒,试剂盒种类多、使用简便,灵敏度高,批间差小,广泛应用可用于药品纯度鉴定和药品生产工艺研发。

宿主残留蛋白(Host Cell Protein,简称HCP)是指在生物制品中残留的宿主蛋白。这类蛋白成分复杂,种类繁多,且会因生产过程及纯化工艺的不同而发生变化。基因工程制品中残留的宿主细胞蛋白是影响生物制品纯度的重要因素,反复使用含宿主细胞蛋白的生物制品,有可能会引起机体的过敏反应,而且其具有潜在的“佐剂效应”,也可能引起机体对药物产生抗体,进而影响药物的疗效。因此,HCP在生物制品中的残留量反映的不仅是生物制品批间的一致性,而且是衡量生物制备质量的一个重要指标。因此在生物制品制备中必须最大限度的减少宿主成分的残留。

美国Cygnus technologies公司专业提供用于检测宿主蛋白的Western blot 和ELISA 试剂盒。Western blot 用于定性分析宿主蛋白的残留,不能做定量,检测灵敏度受限,只是用于确定是否有宿主蛋白的残留。因此,Western blot试剂盒,多用于蛋白纯化工艺上游的检测。ELISA 试剂盒用于蛋白纯化工艺的下游检测,该试剂盒灵敏度远超过Western blot,可用于检测纯化工艺中所有的污染物的检测。此外,公司还提供用于宿主细胞DNA检测试剂盒,用于提取、扩增及宿主DNA的检测试剂盒。

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