单克隆抗体下游工艺

用于开发和生产的产品

日益先进的上游工艺带来了更高的细胞密度和抗体滴度，给下游纯化带来了复杂的挑战。下游生物工艺的重点是高效回收和纯化，同时控制微生物含量并确保病毒安全，保证患者药物安全。下游工作流程包括澄清、色谱分析、浓缩、病毒清除和无菌过滤步骤，对于确保单克隆抗体(mAb)产品质量、产量、安全性和无菌性至关重要。

下游工艺

最大限度提高下游生物工艺的生产力

下游工艺包括许多纯化和过滤装置操作，各自必须做到稳健、可放大且经过优化，以减少单克隆抗体(mAb)损失并最大程度地提高产品产量。

从工艺开发到放大乃至全面生产，借助我们的 Millipore^®和SAFC^®缓冲液、就地清洗(CIP)溶液、多次和一次性系统、即插即用技术和验证服务等一系列工具，加速开发进程并确保成本效益。我们将上述技术与自身应用专长相结合，自如应对任何下游工艺挑战。

通过使用颗粒状原料、实施各种工艺强化策略、运用封闭式工艺或进行数字化集成，可进一步提高下游生产力。

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