mAb产品表征

将单克隆抗体（mAb）从概念到临床推进时，选对产品表征服务合作伙伴至关重要。我们将协助您一起降低开发和生产流程的风险，加快产品关键阶段的质量决策。  

预配置的即用型检测试剂盒可加快获取可执行数据的时间

我们完整的计划可为您揭示分子在各个发展阶段的真实面貌，为您的生物治疗方法安全性、纯度和效能保驾护航。我们提供mAb检测试剂盒供您选择，还可根据您的生物应用量身定制检测试剂盒。找到合适的合作伙伴，顺利让您的生物疗法面世。

• 早期产品开发表征
• 批次间产品和生物仿制药可比性
• 批次放行和稳定性 
• 工艺流程和产品杂质

如需说明您的特定需求，推进您生物疗法的发展，请联系我们的产品表征专家。

具有专业特长并可满足您特定需求的合作伙伴

BioReliance^® 测试服务可帮助您将安全的新疗法推向市场，在从药物发现到上市批准的每个开发步骤为您提供全面的生物疗法表征、安全性测试和工艺开发产品。我们经验丰富的团队，运营专业知识，再加上对监管的深入理解，能够帮助您将每个流程步骤的风险降至最低。

相关产品资源

网络研讨会：通过产品表征降低风险
网络研讨会：工艺流程杂质：不要让PEI或HCP影响您的生物疗法

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相关视频

Slide 1 of 4

Biotherapy Characterization: Cell-Based Assays

Senior Scientist, Agata Burzawa, MSc, describes how designing cell-based assays to help our clients understand the complex biological functions of the therapy they are developing as a part of product characterization.

Biotherapy Characterization: Binding Assays

Senior Scientist Helen Hsu, Ph.D. describes how, with our custom binding assays, and supported with our comprehensive off-the-shelf Fc gamma receptor binding assays, we can help you optimize your mAb production, from clone development through upstream and downstream processes.

Explore What's Next in Product Characterization

The complexities of biological manufacturing, the large size of the molecules, and the product heterogeneity introduced by cellular expression systems present significant challenges to measuring the quality of a biologic drug. Newer, high-resolution analytical techniques help answer questions regarding product heterogeneity and drug functions, and help assess for product-related aggregates and impurities.

Understanding Cytokine Activation

Product Characterization Scientist, Rachel Wood, introduces the multiplexed cytokine release assay. A highly sensitive assay that requires low sample volumes to measure the cytokine release activity induced by your mAb.