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A consensus rating method for small virus-retentive filters. I. Method development.

Scott Lute1, William Riordan, Leonard F Pease

  • 1Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Blvd., Silver Spring, MD 20903, USA.

PDA Journal of Pharmaceutical Science and Technology
|December 6, 2008
PubMed
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This summary is machine-generated.

The Parenteral Drug Association (PDA) developed a standardized test method for classifying small virus-retentive filters. This method uses bacteriophage PP7 retention for accurate viral clearance assessment in biopharmaceutical manufacturing.

Area of Science:

  • Biopharmaceutical Manufacturing
  • Filtration Technology
  • Viral Clearance

Background:

  • Virus filters are essential membrane-based devices for removing viruses from pharmaceutical products via size exclusion.
  • The Parenteral Drug Association (PDA) established a Virus Filter Task Force in 2002 to standardize viral-retentive filter classification and testing.
  • A key objective was developing a robust test method specifically for small virus-retentive filters, which present unique challenges.

Purpose of the Study:

  • To develop a standardized test method for classifying small virus-retentive filters.
  • To address the unique technical challenges associated with testing small virus filters.
  • To establish a consensus method for evaluating viral retention capabilities.

Main Methods:

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  • Laboratory studies were conducted to identify critical variables for filter testing.
  • Variables included bacteriophage challenge selection, model protein choice, and filtration parameters.
  • Multiple analytical techniques, including filtration, DLS, electrospray differential mobility analysis, and PCR, were employed.

    • Main Results:

    • A consensus method was established based on the retention of bacteriophage PP7.
    • This method provides a reliable rating for small virus-retentive filters.
    • The finalized method was published in PDA Technical Report 41 (2008 update).

    Conclusions:

    • The developed test method offers a standardized approach to classifying small virus-retentive filters.
    • This standardization is critical for ensuring the safety and efficacy of biopharmaceutical products.
    • The method provides a reliable benchmark for viral clearance in manufacturing processes.