Development of a rabbit monocyte activation test as an alternative to the rabbit pyrogen test and its application in the analysis of plasma-derived products

The rabbit pyrogen test (RPT) is a safety test conducted as a part of mandatory requirements of regulatory agencies. RPT is currently performed for routine quality control (QC) by manufacturers and for national lot release of biological products, such as plasma-derived products. However, RPT involve...

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Veröffentlicht in:Biologicals 2021-06, Vol.71, p.20-30
Hauptverfasser: Kim, Ji-Hye, Jung, Kikyung, Kim, Jaeok, Lee, Jiyoung, Kim, HyunJeong, Song, Hojin, Han, Kiwon, Park, Sangmi, Ahn, Chiyoung, Kim, Chan-Wha
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container_end_page 30
container_issue
container_start_page 20
container_title Biologicals
container_volume 71
creator Kim, Ji-Hye
Jung, Kikyung
Kim, Jaeok
Lee, Jiyoung
Kim, HyunJeong
Song, Hojin
Han, Kiwon
Park, Sangmi
Ahn, Chiyoung
Kim, Chan-Wha
description The rabbit pyrogen test (RPT) is a safety test conducted as a part of mandatory requirements of regulatory agencies. RPT is currently performed for routine quality control (QC) by manufacturers and for national lot release of biological products, such as plasma-derived products. However, RPT involves the use of many rabbits, counter to the international efforts to minimize the use of animals in research. Furthermore, pyrogen amount cannot be discerned from the test results and the results may be considerably affected by various factors. Therefore, a need exists for substituting RPT with in vitro assays. As a viable alternative to RPT, we here established a rabbit monocyte activation test (RMAT) based on the human MAT in the European Pharmacopoeia. RMAT uses rabbit peripheral blood mononuclear cells as the source of monocytes instead of live animals. The test detected endotoxin, lipoteichoic acid, peptidoglycan, and zymosan with high sensitivity, showing high correlation with the in vivo RPT results. The results of RMAT and RPT testing of non-pyrogenic plasma-derived products were also consistent. Furthermore, RMAT showed satisfactory recovery rates in an interference test with product samples and spiked-in pyrogens. We conclude that RMAT could replace the existing RPT for routine QC.
doi_str_mv 10.1016/j.biologicals.2021.04.003
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subjects Animal use reduction
Plasma-derived product
Rabbit monocyte activation test
Rabbit pyrogen test
title Development of a rabbit monocyte activation test as an alternative to the rabbit pyrogen test and its application in the analysis of plasma-derived products
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