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病毒清除的风险管理:关于采用平台验证方法和流程更改风险管理的案例研究

Na Liu1, Runze Wu1

  • 1Downstream Process Development (DSPD), WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.

Biologicals : journal of the International Association of Biological Standardization
|August 13, 2024
PubMed
概括

病毒清除研究对于生物制药来说至关重要. 一个新的风险管理工具有助于平台验证和流程更改,可能减少一些研究并确保病毒安全.

关键词:
平台验证平台的验证过程变化 过程变化.风险评估 风险评估 风险评估控制风险 控制风险 控制风险风险管理 风险管理病毒清除时间

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