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Virus removal by filtration.

E G Graf1, E Jander, A West

  • 1Pall GmbH Filtrationstechnik, Dreieich, Germany.

Developments in Biological Standardization
|July 15, 1999
PubMed
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Membrane filtration effectively removes viruses from pharmaceutical products. This study validates microfiltration and ultrafiltration using bacteriophages, ensuring enhanced product safety through rigorous testing.

Area of Science:

  • Biopharmaceutical manufacturing
  • Membrane science and technology
  • Viral safety

Background:

  • Membrane technology advancements enable virus removal via size-exclusion.
  • Pharmaceutical production relies on safe biological fluids and cell cultures.

Purpose of the Study:

  • To evaluate membrane filtration for virus removal in biopharmaceuticals.
  • To validate the efficacy of microfiltration and ultrafiltration membranes.

Main Methods:

  • Utilized direct flow and cross-flow filtration techniques.
  • Employed bacteriophages as model viruses for challenge studies.
  • Conducted non-destructive filter integrity tests pre- and post-filtration.

Main Results:

Related Experiment Videos

  • Demonstrated significant virus titre reduction using microfiltration and ultrafiltration membranes.
  • Validated the effectiveness of complementary filtration techniques.
  • Confirmed the reliability of integrity testing for process control.

    • Conclusions:

    • Membrane filtration is a robust method for viral clearance in pharmaceuticals.
    • Rigorous process validation and integrity testing enhance product safety.
    • This approach supports the production of safe biologics from cell cultures and biological fluids.