本技术报告由PDA病毒穗准备工作组的志愿者编写。第47号技术报告《用于病毒清除研究的病毒峰的制备》代表了一个国际工作组的努力，以确定可应用于病毒和噬菌体峰制备以及用于病毒繁殖和样品测试的细胞系的质量属性。本技术报告不旨在建立病毒穗制剂的生产标准，也不代表特定病毒的质量属性标准； 相反，它提出了为选定模型病毒选择和定义适当质量属性的重要原则，重点是最小化病毒峰值本身对在工艺装置操作的缩小模型上进行的验证研究（病毒清除）结果的影响。在TR开发的早期，团队决定采用案例研究方法，技术报告中遵循了这种方法。第47号技术报告补充了PDA第42号技术报告《蛋白质制造工艺验证》（2005年完成）和第。 41关于2008年修订的病毒过滤。

This Technical Report was prepared by volunteer members of the PDA Virus Spike Preparation Task Force. Technical Report No. 47, Preparation of Virus Spikes Used for Virus Clearance Studies represents the efforts of an international task force to define the quality attributes that may be applied to virus and bacteriophage spike preparations, as well as to cell lines used for virus propagation and sample testing. This Technical Report is not intended to establish standards for the production of virus spike preparations or to represent standards for quality attributes for particular viruses; rather it presents principles important in selecting and defining appropriate quality attributes for selected model viruses, with an emphasis on minimizing the impact of the virus spike itself on the results of validation studies (viral clearance) conducted on scale down models of the process unit operation. Early in the TR development, the team decided to take a case study approach, and this approach was followed in the Technical Report. Technical Report No. 47 complements PDA Technical Report No. 42, Process Validation of Protein Manufacturing, completed in 2005, and Technical Report No. 41 on Viral Filtration which was revised in 2008.