Evaluation of the Effect of Betapropiolactone/Ultraviolet Irradiation (BPL/UV) Treatment of Source Plasma on Hepatitis Transmission by Factor IX Complex in Chimpanzees

Alfred M Prince; W Stephan; B Brotman; M C van den Ende

doi:10.1055/s-0038-1650104

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1980; 44(03): 138-142
DOI: 10.1055/s-0038-1650104

Original Article

Schattauer GmbH Stuttgart

Evaluation of the Effect of Betapropiolactone/Ultraviolet Irradiation (BPL/UV) Treatment of Source Plasma on Hepatitis Transmission by Factor IX Complex in Chimpanzees

Authors

Alfred M Prince

¹The Lindsley F. Kimball Research Institute of The New York Blood Center, New York, and Dept. of Pathology, New York Hospital/Cornell Medical Center
W Stephan

²The Biotest Serum Institute, GmbH, Frankfurt (Main), West Germany
B Brotman

¹The Lindsley F. Kimball Research Institute of The New York Blood Center, New York, and Dept. of Pathology, New York Hospital/Cornell Medical Center

³The Vilab II, The Liberian Institute for Biomedical Research, Robertsfield, Liberia
M C van den Ende

¹The Lindsley F. Kimball Research Institute of The New York Blood Center, New York, and Dept. of Pathology, New York Hospital/Cornell Medical Center

³The Vilab II, The Liberian Institute for Biomedical Research, Robertsfield, Liberia

Abstract

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Summary

To evaluate the safety of a β-Propiolactone/Ultraviolet (BPL/UV), irradiated Factor IX complex preparation we inoculated 8 chimpanzees with 25 units Factor IX/Kilo from a pool of 5 production lots which had been treated in this manner. These lots were derived from approximately 1,000 donors. Animals were followed with weekly tests for hepatitis B serologic markers and transaminases, and biweekly liver biopsies, for 6 months. No evidence of transmission of hepatitis B, or non-A, non-B viruses was observed.

To further evaluate the BPL/UV procedure a plasma pool was intentionally contaminated with hepatitis B virus and one half of the pool treated with BPL/UV. Factor IX complex was isolated from the treated and untreated pools and each was inoculated into 4 chimpanzees. The Factor IX derived from untreated plasma infected all four animals with an average incubation period of 10.5 weeks, whereas that prepared from BPL/UV treated plasma infected only one of four animals with an incubation period of 21 weeks. These results were interpreted as suggesting that BPL/UV can inactivate approximately 99.9% of hepatitis B virus infectivity.

Key words

Factor IX complex - Hepatitis viruses-β-propiolactone

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References

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