Abstract:
:OCTAPLAS is a cell-free standardized blood group specific human coagulation active plasma for transfusion. The viral safety is mainly based on the treatment with solvent/detergent. SD is known to irreversibly inactivate the lipid enveloped viruses including HIV 1 + 2, HBV and HCV and has been recommended both by European guidelines and the FDA. The potential limitation of each inactivation method should be validated according to the current EU-guidelines CPMP/BWP/268/95 and CPMP/BWP/269/95. Our studies demonstrate that the SD method inactivates lipid enveloped viruses within a few minutes to below the limit of detection. The concentration of the SD reagents as well as several other process parameters chosen for the virus inactivation step of plasma pools of different protein and lipid composition result in a high safety margin towards the clinically relevant viruses.
journal_name
Vox Sangjournal_title
Vox sanguinisauthors
Biesert L,Suhartono Hdoi
10.1111/j.1423-0410.1998.tb05474.xsubject
Has Abstractpub_date
1998-01-01 00:00:00pages
207-12eissn
0042-9007issn
1423-0410journal_volume
74 Suppl 1pub_type
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