SAFETY ASSESSMENT OF ALBUMIN PREPARATIONS MANUFACTURING WITH RESPECT TO PARVOVIRUS B19 |
1 | |
2012 |
scientific article | 577.112.083 | ||
96-99 | albumin, plasma fractionation, viral safety, parvovirus B19, viral reduction |
We have carried out model ethanol fractionation of plasma pools containing parvovirus B19 to determine viral DNA distribution over albumin manufacturing stages. The purpose of the study was to evaluate the efficacy of ethanol fractionation at additional stages for the removal/inactivation of parvovirus B19 during the manufacturing of albumin. The safety of albumin production technology has been confirmed by the results of the study of albumin preparations manufactured during 2008-2010. |
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