下游 mAbs

开发和制造产品

越来越先进的上游工艺所产生的更高细胞密度和抗体滴度带来了复杂的下游纯化挑战。下游生物处理的重点是高效回收和纯化，同时控制生物负荷并确保病毒安全性，从而为患者提供安全的药物。下游工作流程包括澄清、层析、浓缩、病毒清除和无菌过滤步骤，对于确保单克隆抗体 (mAb) 产品的质量、产量、安全性和无菌性至关重要。

下游处理

病毒过滤

浓缩和渗滤

病毒过滤

为确保单克隆抗体（mAb）疗法的安全性，下游纯化步骤必须有效清除不同理化特性的病毒。病毒过滤是大多数生产工艺中使用的专用病毒清除步骤，可提供基于大小的病毒清除，是色谱法或通过化学处理灭活病毒等其他病毒清除技术的补充。了解影响病毒过滤性能的参数对于优化病毒过滤能力、通量和保留率至关重要。

我们的病毒过滤产品组合包括：

Bioreliance^®合同测试服务病毒清除测试
Millipore^® 病毒过滤器
Millipore^® 病毒过滤器支架和一次性病毒过滤系统
Millipore^® 自动化完整性测试仪<
飞利浦^®服务（一次性使用和过滤器验证、设备安装、系统鉴定、系统培训、系统服务）
飞利浦^®自动化和分析软件

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