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疫苗
疫苗

 全套疫苗评估和检测服务

疫苗

全套疫苗评估和测试服务

方达的科学团队拥有数十年的行业经验,能够提供从临床前到批准后的专业知识来支持疫苗开发项目。我们提供全方位的疫苗服务,从开发、鉴定和验证到广泛的统计和监管专业知识,再到高通量、自动化和/或多重分析,以支持成人和儿童适应症。方达拥有丰富的监管经验,在美国领先的全球权威机构进行了18次以上的检查。我们在GLP、GCP、ANVISA和CLIA法规下运营。

方达疫苗科学实验室通过提供效力和伴随使用测试服务,支持新疫苗、改良疫苗和组合疫苗的提交。方达团队正在支持检测,以监测疫苗诱导的免疫原性、安全性和有效性。

不同的测试 和实验 的设计用来监测各种参数和疫苗的效果。从实验开发、验证到临床测试和监管批准,我们提供快速和完整的疫苗开发所需的技术和科学专业知识。

提供的测试和实验:

  • 抗原检测/定量RT-PCR/测序
  • 传统和多重免疫分析
  • 中和抗体检测
  • T细胞亚群分析
  • 用于细胞因子分析的 Th1/Th2 可定制面板
  • 细胞因子生物标志物检测
  • 细胞介导的免疫方法
  • 多种病毒和细菌功能测定

疫苗科学实验室拥有一系列有用且多样化的技术和仪器,可支持您的开发和测试需求。我们多样化的能力包括使用各种平台。

分子检测 免疫学检测 细胞因子生物标志物检测
实时 PCR/QuantStudio 5/7Flex ddPCR ELISA/EIA Quanterix Simoa®
Diasorin Liaison MDX MSD® 电化学发光
Illumina NGS测序 GYROS
Luminex® Multiplexed
Navios EX 流式细胞仪 (FACS)
酶联免疫斑点 (ELISPOT)
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