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 |
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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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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.</description><identifier>ISSN: 1045-1056</identifier><identifier>EISSN: 1095-8320</identifier><identifier>DOI: 10.1016/j.biologicals.2021.04.003</identifier><identifier>PMID: 33994086</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Animal use reduction ; Plasma-derived product ; Rabbit monocyte activation test ; Rabbit pyrogen test</subject><ispartof>Biologicals, 2021-06, Vol.71, p.20-30</ispartof><rights>2021 International Alliance for Biological Standardization</rights><rights>Copyright © 2021 International Alliance for Biological Standardization. Published by Elsevier Ltd. 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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.</description><subject>Animal use reduction</subject><subject>Plasma-derived product</subject><subject>Rabbit monocyte activation test</subject><subject>Rabbit pyrogen test</subject><issn>1045-1056</issn><issn>1095-8320</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNqNkUuPFCEUhYlx4jz_gsGdmyqhoF5L074mmcSNsyYX6jLSqYIS6E76v_hjpaenjUtX3JDvnHNvDiHvOKs5492Hba1dmMOTMzCnumENr5msGROvyBVnY1sNomGvj7NsK87a7pJcp7RljHPZyzfkUohxlGzorsjvT7jHOawL-kyDpUAjaO0yXYIP5pCRgsluD9kFTzOmTCFR8BTmjNGX7z3SHGj-iWfheojhCc-wn6jLRbGuc9n22cX5Zxw8zIfk0jF1nSEtUE0Yi99E1ximncnpllzYciHevbw35PHL5x-bb9XD96_3m48PlRF9nythAC30mg0SNHDeD72xVgjeyd5q3uq-HzWzrRWdQDnYjmNnJiFQj1Y3YMQNeX_yLcG_dmVvtbhkcJ7BY9gl1bTNIEUnBSvoeEJNDClFtGqNboF4UJypYzlqq_4pRx3LUUyqUk7Rvn2J2ekFp7_KcxsF2JwALMfuHUaVjENvcHIRTVZTcP8R8wfBB6r-</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Kim, Ji-Hye</creator><creator>Jung, Kikyung</creator><creator>Kim, Jaeok</creator><creator>Lee, Jiyoung</creator><creator>Kim, HyunJeong</creator><creator>Song, Hojin</creator><creator>Han, Kiwon</creator><creator>Park, Sangmi</creator><creator>Ahn, Chiyoung</creator><creator>Kim, Chan-Wha</creator><general>Elsevier Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20210601</creationdate><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</title><author>Kim, Ji-Hye ; Jung, Kikyung ; Kim, Jaeok ; Lee, Jiyoung ; Kim, HyunJeong ; Song, Hojin ; Han, Kiwon ; Park, Sangmi ; Ahn, Chiyoung ; Kim, Chan-Wha</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c377t-3caefa7b084aba11787cff331647fb15b779b0f5f363e48f61e6cd33eb9fb2ac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Animal use reduction</topic><topic>Plasma-derived product</topic><topic>Rabbit monocyte activation test</topic><topic>Rabbit pyrogen test</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Ji-Hye</creatorcontrib><creatorcontrib>Jung, Kikyung</creatorcontrib><creatorcontrib>Kim, Jaeok</creatorcontrib><creatorcontrib>Lee, Jiyoung</creatorcontrib><creatorcontrib>Kim, HyunJeong</creatorcontrib><creatorcontrib>Song, Hojin</creatorcontrib><creatorcontrib>Han, Kiwon</creatorcontrib><creatorcontrib>Park, Sangmi</creatorcontrib><creatorcontrib>Ahn, Chiyoung</creatorcontrib><creatorcontrib>Kim, Chan-Wha</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Biologicals</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Ji-Hye</au><au>Jung, Kikyung</au><au>Kim, Jaeok</au><au>Lee, Jiyoung</au><au>Kim, HyunJeong</au><au>Song, Hojin</au><au>Han, Kiwon</au><au>Park, Sangmi</au><au>Ahn, Chiyoung</au><au>Kim, Chan-Wha</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Biologicals</jtitle><addtitle>Biologicals</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>71</volume><spage>20</spage><epage>30</epage><pages>20-30</pages><issn>1045-1056</issn><eissn>1095-8320</eissn><abstract>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. 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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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