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Expression and Purification of Virus-like Particles for Vaccination
Published on: June 2, 2016
H5N1 influenza virus and the safety of plasma products
1Global Pathogen Safety and R&D Vaccines, Baxter BioScience, Vienna, Austria. thomas_kreil@baxter.com
Background:
The ever-increasing number of human H5N1 influenza virus infections may enable these viruses to acquire the ability to spread effectively among humans and potentially to cause a pandemic. Recently, more systemic virus dissemination was reported during H5N1 virus infection of humans, resulting in significant virus concentrations also in the blood. The observation has raised concerns about the safety of labile blood products for transfusion and consequentially also for plasma derivatives. To confirm the safety margins of plasma products, dedicated virus inactivation processes used during their production were investigated for their effectiveness in inactivating this virus of recent concern.
Study Design And Methods:
Virus inactivation by steps commonly used during the manufacture of plasma derivatives, such as pasteurization for human albumin, solvent/detergent treatment for intravenous immunoglobulin (IVIG), vapor heating for factor VIII inhibitor bypassing activity, and incubation at low pH for IVIG, were investigated with a reassortant strain of H5N1 influenza virus.
Results:
The results show that H5N1 influenza behaves as expected for lipid-enveloped viruses; that is, the virus is effectively inactivated by all the commonly used virus inactivation procedures tested.
Conclusion:
The safety margins of plasma derivatives against the theoretical transmission of H5N1 influenza virus are very substantial.
Insights
Plasma derivatives are safe from H5N1 influenza virus transmission. Standard virus inactivation methods effectively neutralize H5N1, ensuring the safety of blood products and preventing potential pandemics.
Area of Science:
- Virology
- Blood Product Safety
- Infectious Diseases
Background:
- Human H5N1 influenza infections are increasing, raising pandemic concerns.
- Systemic virus dissemination in H5N1 infections includes significant blood concentrations.
- This necessitates evaluating the safety of blood products and plasma derivatives.
Purpose of the Study:
- To assess the effectiveness of virus inactivation processes used in plasma derivative manufacturing.
- To confirm the safety margins of plasma products against H5N1 influenza virus transmission.
Main Methods:
- Investigated inactivation of a reassortant H5N1 influenza virus strain.
- Tested common manufacturing steps: pasteurization, solvent/detergent treatment, vapor heating, and low pH incubation.
Main Results:
- H5N1 influenza virus, a lipid-enveloped virus, was effectively inactivated by all tested procedures.
- Standard virus inactivation methods demonstrated efficacy against H5N1.
Conclusions:
- Plasma derivatives possess substantial safety margins against H5N1 influenza virus transmission.
- Current manufacturing processes ensure the safety of plasma products concerning H5N1.
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