Cygnus 产品代理

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Cygnus 产品代理

Cygnus Technologies 是 Maravai LifeSciences 的一部分,是生物制药行业在宿主细胞蛋白 (HCP) 和其他与工艺相关的杂质检测和分析方面的合作伙伴。此外,Cygnus 现在还提供创新的病毒清除解决方案。
Cygnus 帮助公司开发治疗性蛋白质、疫苗、抗体、血浆衍生物和基因疗法,以确保生物治疗药物在人体试验、监管批准和商业发布之前的安全性。 Cygnus 提供分析工具和解决方案,提供洞察力以改进生物工艺开发,从而更快获得监管批准和更好的临床结果。
Cygnus 是负责开发和商业化第一个用于 HCP 检测的通用检测试剂盒的行业先驱。其质量声誉得到行业和全球监管机构的认可。它通过新的突破继续推进生物过程杂质检测的科学,包括其抗体亲和提取™ (AAE) 技术和 HCP 分析的正交方法,集成了质谱、AAE 和 ELISA。为了降低与病毒清除研究相关的成本和风险,Cygnus 还提供了一种独特的方法,通过其 MockV™ 病毒清除试剂盒利用非传染性模拟病毒颗粒。
Cygnus 的专有技术可通过其现成的和定制的分析程序获得,为实现 HCP 和其他生物过程杂质抗体测定设定了黄金标准。 Cygnus 提供一流的客户服务和技术专长、卓越的运营和 ISO-9001:2015 认证的质量管理体系。
Cygnus 由 Ken Hoffman 于 1997 年创立,继续支持和推进技术,以提高生物治疗安全性并通过开发和监管批准程序加速新疗法的发展。
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Cygnus   Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host   cell protein (HCP) and other process-related impurity detection and   analytics. In addition, Cygnus now provides innovative viral clearance   solutions as well.

Cygnus helps   companies developing therapeutic proteins, vaccines, antibodies, plasma   derivatives and gene therapies to ensure the safety of biotherapeutics prior   to human trials, regulatory approval and commercial release. Cygnus provides   analytical tools and solutions delivering insights to improve bioprocess   development for faster regulatory approval and better clinical outcomes. 

   

Cygnus is an industry pioneer responsible for developing and 

commercializing   the first generic assay kits for HCP detection. Its reputation for quality is   recognized by the industry and global regulatory agencies. It continues to   advance the science of bioprocess impurity detection with new breakthroughs,   including its Antibody Affinity Extraction™ (AAE) technology and orthogonal methods of HCP analysis that   integrate Mass Spectrometry, AAE and ELISA. To reduce the cost and risk   associated with viral clearance studies, Cygnus also offers a unique approach   that utilizes non-infectious mock virus particles through its MockV™ virus clearance   kits.

Cygnus’ proprietary   technology, available through its off-the-shelf and custom analytics   programs, sets the gold standard for enabling HCP and other bioprocess   impurity antibody assays. Cygnus delivers best-in-class customer service and   technical expertise, operational excellence and ISO-9001:2015 certified   quality management systems.

   

Founded by Ken Hoffman in 1997, Cygnus continues to support and advance technology in order to improve biotherapeutic safety and accelerate the movement of new therapeutics through the development and regulatory approval process.