Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2034439 | Biologicals | 2009 | 6 Pages |
Abstract
Treatment with solvent/detergent is a widely used method for ensuring the virus safety of plasma products. In the present study, virus inactivation by a novel solvent/detergent combination, i.e. TnBP (tri-n-butyl phosphate) and polysorbate 20 during the manufacture of the factor VIII/VWF concentrate Optivate® has been investigated. The inactivation of most enveloped viruses was rapid, i.e. >5Â log in 2Â min, although the inactivation of vaccinia virus was slower, i.e. 4Â log in 1Â h. Virus inactivation was effective over a wide range of conditions, i.e. solvent/detergent concentration, protein concentration and temperature, irrespective of whether tested individually or in combination. This confirms the effectiveness and robustness of this alternative version of the solvent/detergent procedure, and allows appropriate control limits to be set for this manufacturing step. Polysorbate 20 provides an alternative to the non-ionic detergents currently in use with the solvent/detergent procedure.
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Authors
Peter L. Roberts, David Lloyd, Philip J. Marshall,