Virus retention by a hydrophilic triple-layer PVDF microporous membrane filter
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H Aranha-Creado1, K Oshima, S Jafari
1Pall Corporation, Port Washington, New York, USA.
Abstract:
Retention of bacteriophages (phi 6, PR772, T1, and PP7) and mammalian viruses (poliovirus and influenza A virus) by a hydrophilic triple layer PVDF microporous membrane, the Ultipor VF grade DV50 membrane, was evaluated. Challenges of membrane discs or pleated filter cartridges were performed at concentrations of 10(6)-10(8) PFU/mL in one or more of the following carrier fluids: water, saline, gelatin (0.1%) in phosphate buffer, Dulbecco's Modified Eagle Medium (MEM), and MEM supplemented with 10% fetal bovine serum (MEM + 10). The data demonstrate a minimum log titer reduction (LTR) of 6 for viruses larger than 50 nm irrespective of the carrier fluid. Protein transmission levels of greater than 95% for IgG and albumin were achieved. For integral pleated filter cartridges, correlation between a nondestructive integrity test (using the forward flow integrity test method) and virus retention was demonstrated. The Ultipor VF grade DV50 filter can be applicable in the manufacture of biologicals and biopharmaceuticals, where high protein transmission and consistent viral titer reduction are desired.
Insights
This study shows the Ultipor VF DV50 membrane effectively removes viruses larger than 50 nm, achieving a minimum log titer reduction of 6. It also maintains high protein transmission, making it suitable for biopharmaceutical manufacturing.
Area of Science:
- Biotechnology
- Filtration Technology
- Virology
Background:
- Effective viral clearance is critical in biopharmaceutical manufacturing to ensure product safety.
- Microporous membranes are widely used for virus removal, but performance can vary with carrier fluid composition.
- Hydrophilic polyvinylidene fluoride (PVDF) membranes offer potential for high protein transmission and viral retention.
Purpose of the Study:
- To evaluate the viral retention capabilities of the Ultipor VF grade DV50 hydrophilic triple-layer PVDF microporous membrane.
- To assess the impact of various carrier fluids on virus retention and protein transmission.
- To demonstrate the correlation between a nondestructive integrity test and virus retention in filter cartridges.
Main Methods:
- Virus retention studies were conducted using bacteriophages (phi 6, PR772, T1, PP7) and mammalian viruses (poliovirus, influenza A virus).
- Filtration challenges were performed on membrane discs and pleated filter cartridges at viral concentrations of 10(6)-10(8) PFU/mL.
- Carrier fluids included water, saline, gelatin buffer, MEM, and MEM with 10% fetal bovine serum.
- Protein transmission for IgG and albumin was measured.
- Forward flow integrity testing was used to correlate with virus retention in pleated cartridges.
Main Results:
- A minimum log titer reduction (LTR) of 6 was consistently achieved for viruses larger than 50 nm, regardless of the carrier fluid.
- Protein transmission levels exceeded 95% for both IgG and albumin.
- A strong correlation was demonstrated between the forward flow integrity test and virus retention performance in pleated filter cartridges.
Conclusions:
- The Ultipor VF grade DV50 membrane demonstrates robust viral retention (>6-log reduction) and high protein transmission (>95%).
- The filter's performance is consistent across various biologically relevant carrier fluids.
- The demonstrated correlation between integrity testing and viral retention supports its use in quality control for biopharmaceutical manufacturing.
