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Related Experiment Videos

Virus removal studies using nanofiltration membranes

J O'Grady1, A Losikoff, J Poiley

  • 1Department of Process Biochemistry, Medlmmune, Inc. Gaithersburg, MD, USA.

Developments in Biological Standardization
|January 1, 1996
PubMed
Summary
This summary is machine-generated.

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This study shows Planova nanofiltration membranes effectively remove viruses from immunoglobulin products. Both 15 nm and 35 nm membranes demonstrated significant virus clearance, ensuring product safety.

Area of Science:

  • Biotechnology
  • Pharmaceutical Manufacturing
  • Virology

Background:

  • Immunoglobulin products require robust virus removal steps.
  • Nanofiltration is a promising technology for viral clearance in biopharmaceuticals.

Purpose of the Study:

  • To evaluate the efficacy of Planova nanofiltration membranes for virus removal from immunoglobulin G (IgG) and immunoglobulin M (IgM) preparations.
  • To assess the performance of 15 nm and 35 nm Planova membranes against model viruses.

Main Methods:

  • Spiking studies using four model viruses: murine xenotropic retrovirus, simian virus 40, pseudorabies virus, and poliovirus.
  • Testing of 15 nm and 35 nm Planova nanofiltration membranes with purified IgG and IgM.
  • Evaluation of virus removal capacity and protein recovery at various protein concentrations.

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Main Results:

  • Both Planova 15 nm and 35 nm membranes achieved 6-7 log10 reduction of murine xenotropic retrovirus, simian virus 40, and pseudorabies virus.
  • The Planova 15 nm membrane effectively removed poliovirus, while two tandem Planova 35 nm membranes did not.
  • Excellent protein recovery was observed for both IgG and IgM at tested concentrations (up to 12 mg/ml for IgG, 1-2 mg/ml for IgM).

Conclusions:

  • Planova nanofiltration membranes are effective for virus removal in immunoglobulin purification.
  • The 15 nm membrane shows broader virus clearance, including poliovirus, compared to the 35 nm membrane.
  • Nanofiltration offers a viable and efficient method for enhancing the safety of immunoglobulin products.