Nanofiltration of plasma-derived biopharmaceutical products

Thierry Burnouf, M. Radosevich

研究成果: 雜誌貢獻回顧型文獻

148 引文 (Scopus)

摘要

This review presents the current status on the use and benefits of viral removal filtration systems - known as nanofiltration - in the manufacture of plasma-derived coagulation factor concentrates and other biopharmaceutical products from human blood origin. Nanofiltration of plasma products has been implemented at a production scale in the early 1990s to improve margin of viral safety, as a complement to the viral reduction treatments, such as solvent-detergent and heat treatments, already applied for the inactivation of human immunodeficiency virus, hepatitis B and hepatitis C virus. The main reason for the introduction of nanofiltration was the need to improve product safety against non-enveloped viruses and to provide a possible safeguard against new infectious agents potentially entering the human plasma pool. Nanofiltration has gained quick acceptance as it is a relatively simple manufacturing step that consists in filtering protein solution through membranes of a very small pore size (typically 15-40 nm) under conditions that retain viruses by a mechanism largely based on size exclusion. Recent large-scale experience throughout the world has now established that nanofiltration is a robust and reliable viral reduction technique that can be applied to essentially all plasma products. Many of the licensed plasma products are currently nanofiltered. The technology has major advantages as it is flexible and it may combine efficient and largely predictable removal of more than 4 to 6 logs of a wide range of viruses, with an absence of denaturing effect on plasma proteins. Compared with other viral reduction means, nanofiltration may be the only method to date permitting efficient removal of enveloped and non-enveloped viruses under conditions where 90-95% of protein activity is recovered. New data indicate that nanofiltration may also remove prions, opening new perspectives in the development and interest of this technique. Nanofiltration is increasingly becoming a routine step in the manufacture of biopharmaceutical products.
原文英語
頁(從 - 到)24-37
頁數14
期刊Haemophilia
9
發行號1
出版狀態已發佈 - 一月 2003
對外發佈Yes

指紋

Viruses
Safety
Blood Coagulation Factors
Prions
Hepatitis B
Hepacivirus
Detergents
Blood Proteins
Proteins
Hot Temperature
HIV
Technology
Membranes

ASJC Scopus subject areas

  • Hematology

引用此文

Nanofiltration of plasma-derived biopharmaceutical products. / Burnouf, Thierry; Radosevich, M.

於: Haemophilia, 卷 9, 編號 1, 01.2003, p. 24-37.

研究成果: 雜誌貢獻回顧型文獻

Burnouf, T & Radosevich, M 2003, 'Nanofiltration of plasma-derived biopharmaceutical products', Haemophilia, 卷 9, 編號 1, 頁 24-37.
Burnouf, Thierry ; Radosevich, M. / Nanofiltration of plasma-derived biopharmaceutical products. 於: Haemophilia. 2003 ; 卷 9, 編號 1. 頁 24-37.
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