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Title of Article

SAFETY ASSESSMENT OF ALBUMIN PREPARATIONS MANUFACTURING WITH RESPECT TO PARVOVIRUS B19


Issue
1
Date
2012

Article type
scientific article
UDC
577.112.083
Pages
96-99
Keywords
albumin, plasma fractionation, viral safety, parvovirus B19, viral reduction


Authors
Filatova Ekaterina Viktorovna
Filial NPO «Mikrogen» Nizhegorodskoe predpriyatie po proizvodstvu bakteriynykh preparatov «ImBio»

Zubkova Nataliya Vasilevna
Filial NPO «Mikrogen» Nizhegorodskoe predpriyatie po proizvodstvu bakteriynykh preparatov «ImBio»

Korotkova Tatyana Vladimirovna
Filial NPO «Mikrogen» Nizhegorodskoe predpriyatie po proizvodstvu bakteriynykh preparatov «ImBio»

Galgovskaya Svetlana Alfredovna
Filial NPO «Mikrogen» Nizhegorodskoe predpriyatie po proizvodstvu bakteriynykh preparatov «ImBio»


Abstract
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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