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A consensus rating method for small virus-retentive filters. II. Method evaluation.

Kurt Brorson¹, Scott Lute, Mohammed Haque

¹Division of Monoclonal Antibodies, CDER/FDA, 10903 New Hampshire Blvd., Silver Spring, MD 20903, USA.

PDA Journal of Pharmaceutical Science and Technology

|December 6, 2008

Summary

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This summary is machine-generated.

A standardized virus filter testing method, based on bacteriophage PP7 retention, was evaluated and found acceptable for classifying viral-retentive filters. This method ensures effective removal of small viruses, crucial for product safety.

Area of Science:

Biotechnology
Pharmaceutical Manufacturing
Filtration Technology

Background:

Virus filtration is essential for removing viral contaminants from pharmaceutical products.
Standardized methods are needed for classifying viral-retentive filters.
The Parenteral Drug Association (PDA) developed a consensus method using bacteriophage PP7 retention.

Purpose of the Study:

To evaluate the acceptability of the PDA's standardized virus filter test method.
To assess the performance of scaled-down virus-retentive filters from multiple manufacturers.

Main Methods:

Testing of five filter types (Pegasus SV4, Viresolve NFP, Planova 20N and 15N, Virosart CPV) from three consecutive lots.
Application of the consensus filter method based on bacteriophage PP7 retention.

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Evaluation of filter performance based on viral retention, product passage, and integrity testing.

Main Results:

All tested filter types met the criteria specified in the PDA method.
Filters demonstrated >4 log10 PP7 retention and >90% intravenous immunoglobulin passage.
All filters passed integrity and installation testing, classified as PP7-LRV4.

Conclusions:

The PDA's standardized virus filter test method is acceptable for classifying small virus-retentive filters.
The evaluated filters from four manufacturers meet the stringent requirements for viral clearance.
This standardized method supports consistent and reliable classification of viral-retentive filters.