Effectiveness of alternative treatments for reducing potential viral contaminants from plasma-derived products.

Abstract:

:An issue of great importance and continuing concern with regard to all products derived from human plasma is their safety from potential contaminants in the source material from which they are purified. Since viral contaminants are a major safety consideration with these products, a number of different methods, including dry heating, vapor heating, filtration and nanofiltration, ultraviolet and gamma irradiation, pasteurization, solvent/detergent (S/D) treatment, sodium thiocyanate treatment, and chromatography (immunoaffinity, metal chelation, affinity, and ion exchange), have been developed to remove or inactivate potentially contaminating viruses. Pasteurization and S/D treatment have emerged as the dominant viral inactivation methods. Results summarized in this review demonstrate that pasteurization is the broadest and most rigorous currently available method for removal of potential viral contaminants from plasma-derived products. S/D treatment requires control over a large number of manufacturing parameters and has no ability to inactivate nonlipid-enveloped viruses. Pasteurization requires control over only a small number of manufacturing variables, is easily monitored, and remains effective even if deviations are encountered from specified protein and stabilizer concentrations and temperature. In addition, pasteurization is effective against a wide range of lipid- and nonlipid-enveloped viruses.

journal_name

Thromb Res

journal_title

Thrombosis research

authors

Chandra S,Groener A,Feldman F

doi

10.1016/s0049-3848(02)00044-0

subject

Has Abstract

pub_date

2002-03-01 00:00:00

pages

391-400

issue

5

eissn

0049-3848

issn

1879-2472

pii

S0049384802000440

journal_volume

105

pub_type

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