𝔖 Bobbio Scriptorium
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Removal/neutralization of hepatitis A virus during manufacture of high purity, solvent/detergent factor VIII concentrate

✍ Scribed by Stanley M. Lemon; Paula C. Murphy; Andrew Smith; Jinsheng Zou; John Hammon; Stephen Robinson; Bernard Horowitz

Publisher
John Wiley and Sons
Year
1994
Tongue
English
Weight
559 KB
Volume
43
Category
Article
ISSN
0146-6615

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✦ Synopsis

Abstract

Recent reports have suggested an increased risk of type A viral hepatitis in hemophilic patients treated with high purity factor VIII concentrates prepared using ion exchange chromatography coupled with solvent/detergent treatment for in‐activation of viruses. To determine the capacity for removal or inactivation of hepatitis A virus during the factor VIM manufacturing process, human plasma and various factor VIM production intermediates were spiked with cell culture‐propagated virus and subjected to scaled down conditions mimicking the manufacture of solvent/ detergent factor VIII. The combination of antibody‐mediated neutralization, cryoprecipitation, anion exchange chromatography, and lyophilization in the absence of sucrose resulted in a minimal reduction of 5.5 to 8.55 Iog~10~ in the infectivity of hepatitis A virus. © 1994 Wiley‐Liss, Inc.

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✍ Tiziana D. Paolantonio; Guglielmo Mariani; Alessandro Ghirardini; Alessandro Gri 📂 Article 📅 1992 🏛 John Wiley and Sons 🌐 English ⚖ 384 KB

## Abstract A study evaluating the risk of a commercial factor VIII (FVIII) concentrate's transmitting the human immunodeficiency virus (HIV) was carried out on hemophiliacs, by using multiple serological markers and the polymerase chain reaction (PCR). Twenty‐nine hemophiliacs, negative for HIV an