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.
Abstract:
Nanofiltration of immunoglobulin products was investigated as a virus removal step using Planova-controlled pore size membranes. For these studies, purified preparations of an IgG and an IgM were tested with 15 nm and 35 nm Planovace nanofiltration membranes, respectively. The results of spiking studies with four model viruses indicated that both the Planova 15 and 35 membranes removed 6-7 log10 plaque or focus forming units of murine xenotropic retrovirus, simian virus 40 and pseudorabies virus. Although two tandem Planova 35 membranes were tested for clearance of poliovirus, only the Planova 15 membrane removed this virus. Nanofiltration experiments were carried out with protein concentrations up to 12 mg/ml for the IgG and 1-2 mg/ml for the IgM, and protein recovery was excellent.
Insights
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.
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.