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Virus Inactivation
Depending on the product, different virus inactivation/removal procedures are employed. Testing of donors and donations can only trace known viruses and those that are screened for. Virus inactivation is one step ahead. The CPMP, Council of Europe and the German Paul Ehrlich Institute all recommend double virus-inactivated plasma products.
Octapharma uses a number of different validated inactivation and removal procedures:
- Solvent/Detergent (SD)
- Pasteurisation
- Dry Heat treatment
- pH4
- Nanofiltration
The SD method rapidly and irreversibly inactivates all lipid-enveloped viruses, i.e. HIV, HBV, HCV. By destroying the lipid coat and the associated virus binding sites, SD treatment prevents infection of target cells and in-vivo virus replication. The following Octapharma products undergo SD inactivation: Octaplas, Octagam, Octanate, Octanine F, Gammanorm, ATenativ, Nanotiv, Rhesonativ.
Pasteurisation is a broad spectrum inactivation method that targets the DNA or RNA of both enveloped and non-enveloped viruses. During pasteurisation, products are heated in the liquid state in the presence of stabilisers. Pasteurisation is used for the inactivation of albumin and as a second step in the production of ATenativ
Dry heat treatment inactivates both enveloped and non-enveloped viruses. Octapharma uses this method as a second virus inactivation step in the production of Octanate.
Prolonged incubation at pH4 can inactivate both enveloped and non-enveloped viruses. Octagam undergoes a 24 hour pH4 incubation.
Nanofiltration is a validated removal method for both enveloped and non-enveloped viruses. It is used as the second inactivation step in the production of Octanine F and Nanotiv.
In addition, the viral safety of Octapharma products is enhanced by immune neutralisation. As plasma-derivatives are made from pooled plasma, donor antibodies against infections are present in the starting material. These antibodies are able to complex with viruses that could potentially enter the plasma pool and neutralise them thereby limiting or preventing virus replication both in vitro and in vivo. Immune neutralisation is an important mechanism contributing to the safety of Octaplas.
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