方达聚焦

视频：方达医药4000平方米上海新实验室正式运营

Frontage Holdings Corporation (“Frontage Holdings” or “Frontage,” stock code: 1521.HK), a Contract Research Organization (“CRO”) providing integrated, science-driven research, analytical and product development services in both the U.S. and China, announced today the opening of a new lab facility in Shanghai, China.

小组讨论会

小组讨论：基因疗法

当细胞是药物时：前沿实验室专家兼生物制剂服务副总裁邵卫平博士主持的细胞与基因治疗小组讨论。

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网络研讨会

微量取样技术在生物分析检测中的应用：DBS和毛细管显微取样

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白皮书

白皮书：CMC使用基于细胞的测定法测量生物制药的生物活性

生物药物化合物（例如肽，单克隆抗体，生长因子和细胞因子）的生物活性直接影响其效能，这是至关重要的品质
属性和功效表示。对于生物制药公司，
measuring a cell’s bioactivity is important when:
• Screening compounds to develop the lead candidate;
• Validating potency when applying for regulatory approval;
• Confirming that the biological characteristics of the productremain consistent throughout the development cycle andfrom lot-to-lot, or site-to-site;
• Controlling for a compound’s quality prior to productrelease (either for a clinical trial or commercialization);
• Testing for stability; and
• Demonstrating biosimilarity between a biosimilar and theoriginator compound.

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