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Virology Whitepaper Series

New!  Is Your Virus Study Under Control?
By Michelle Arvoy, Cynthia Ipach, and Jeri Ann Boose, Ph.D.
Viral Testing and Viral Clearance Studies are expensive and time consuming aspects of pharmaceutical manufacturing.  Various types on control must be considered during planning and performance of viral studies, as well as during evaluation of study results.  This paper details key elements of control which support the assay and virus study design to ensure its validity and success.

Principals of Viral Clearance Study Design and Performance
By Jeri Ann Boose, Ph.D.
Viral Clearance Studies are one of the three main contributors toward achieving assurance that an acceptable level of viral safety has been achieived for a product.  Manufacturers need to justify the level of clearance achieved for each individual virus tested to the regulatory authorities. 

Testing Strategies to Ensure the Viral Safety of Biological Products for Human Use
By Jeri Ann Boose, Ph.D.
The selection and viral testing of cell lines, tissues, and other raw materials, as well as viral testing the product at appropriate steps of the production process, are two of three complimentary approaches toward achieving assurance that an acceptable level of viral safety has been achieved.  

Auditing the Viral Clearance Testing Laboratory
By Jeri Ann Boose, Ph.D., and Michelle Arvoy
This paper outlines the key elements that should be evaluated during a pre-qualification audit.  Development of this outline was based upon application of general GLP/cGMP concepts to the specific requirements of viral clearance. 

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