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Size exclusion removal of model mammalian viruses using a unique membrane system, Part II: Module qualification and

A J DiLeo1, D A Vacante, E F Deane

  • 1Millipore Corporation, Bedford, MA 01730.

Biologicals : Journal of the International Association of Biological Standardization
|September 1, 1993
PubMed
Summary

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This study demonstrates that Viresolve/70 modules effectively and reproducibly retain viruses through a sieving mechanism. The virus removal performance is consistent and the retained viruses are recoverable, showing high log reduction values (LRV).

Area of Science:

  • Biotechnology
  • Membrane Science
  • Virology

Background:

  • Device performance depends on fluid management and manufacturing reproducibility.
  • The Viresolve/70 membrane's performance is maintained when integrated into a fabricated module.

Purpose of the Study:

  • To evaluate the virus retention capabilities of fabricated Viresolve/70 modules.
  • To assess the reproducibility and mechanism of virus retention.
  • To determine virus removal efficiency in protein solutions.

Main Methods:

  • Fabrication of Viresolve/70 modules.
  • Virus retention studies using mammalian viruses (murine leukemia virus, human immunodeficiency virus I).
  • Measurement of retention coefficients at varying recirculation flow rates.

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  • Assessment of virus recoverability.

    • Main Results:

    • Viresolve/70 modules reproducibly retain viruses via a sieving mechanism, independent of virus type.
    • Retention coefficients increase with higher recirculation flow rates.
    • Mammalian viruses are effectively removed, with process clearance factors exceeding 6.7 LRV for murine leukemia virus and 8.5 LRV for human immunodeficiency virus I.
    • Retained viruses are recoverable from the upstream side.

    Conclusions:

    • Fabricated Viresolve/70 modules offer reproducible and effective virus retention.
    • The sieving mechanism is robust across different virus types.
    • The system demonstrates high log reduction values (LRV) for critical viruses, suitable for biopharmaceutical applications.