Background
To ensure high safety margins with respect to adventitious viruses for therapeutic proteins purified from human plasma, different physico-chemical technologies are available to inactivate/remove viruses during manufacturing. Choices are limited for inactivation/removal of non-enveloped viruses which are typically more robust and smaller. Furthermore, when proteins are very large and also sensitive towards harsh treatments, no universally applicable inactivation/removal technology for non-enveloped viruses may be available.
Methods
Protein solutions were treated with Ultraviolet C (UV-C) irradiation at 254 nm with low-pressure mercury lamps. Inactivation of viruses was measured by cell-based infectivity assays (i.e. virus titration)
Results
We show effective inactivation of Hepatitis A virus (HAV) and porcine parvovirus (PPV), a model for human parvovirus B19 (B19V), after irradiation with 200 J/m². Inactivation of lipid-enveloped viruses at this dose showed mixed results . At 100 J/m², inactivation was still effective for PPV.
Conclusion
UV-C irradiation is a valuable virus inactivation tool for proteins from human blood or plasma when other methods cannot be employed for various reasons.
Offenlegung Interessenkonflikt:
Beide Autoren sind Angestellte von Biotest AG, ein kommerzieller Produzent von Arzneimitteln aus humanem Plasma.