Viral infectivity of albumin and plasma protein fraction.

Abstract:

:Original research, reviews, and case reports discussing viral infectivity of blood- and plasma-derived products were reviewed to determine the potential viral infectivity of human serum albumin (HSA) and plasma protein fraction (PPF). Data concerning viral infectivity viral screening and inactivation procedures, and viral outbreaks associated with blood and plasma products were extracted and evaluated for pertinence to HSA and PPF. The starting material used for fractionation, the manufacturing process, postmanufacturing handling, and immunocompetence of HSA or PPF recipients were assessed to determine risk of symptomatic viral disease after transfusion. Both HSA and PPF are manufactured with pasteurization procedures that have led to an excellent viral safety record based on 50 years of clinical use. One outbreak of hepatitis B was associated with PPF as a result of an unreliable manufacturing process that has been corrected. The pasteurization process is effective in eradicating known viral pathogens when good manufacturing practices are followed. Continued surveillance of such products is warranted for viruses not included in routine screening procedures and for those that are resistant to current inactivation methods.

journal_name

Pharmacotherapy

journal_title

Pharmacotherapy

authors

Erstad BL

subject

Has Abstract

pub_date

1996-11-01 00:00:00

pages

996-1001

issue

6

eissn

0277-0008

issn

1875-9114

journal_volume

16

pub_type

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