Technical Report No. 47 (TR 47): Preparation of Virus Spikes Used for Virus Clearance Studies

Feb 2010
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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.

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Table of Contents

Table of Contents:

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Glossary of Terms
Preparation of Virus Stocks
Methods for Characterization
Impact of Virus Spike on the Scaled Down Model and on Virus Removal and Inactivation
Phage Preparations for Spiking Studies
Control of Cells Used for Virus Propagation and Titration