Historical
PDA TR 47-2010
Preparation of Virus Spikes Used for Virus Clearance Studies
It 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.
Content Provider
Parenteral Drug Association [pda]
