{"title":"i -数测定和促红细胞生成素效价:促红细胞生成素生物参比制剂的回顾性毛细管区带电泳数据分析","authors":"H. P.","doi":"10.4172/2157-7064.S8-002","DOIUrl":null,"url":null,"abstract":"The capillary zone electrophoresis data of erythropoietin reference preparations batch 1 (BRP1), batch 2 (BRP2) and batch 3 (BRP3) of three collaborative studies published in 2004, 2007 and 2015 have retrospectively been analyzed by the author via the I-number assay, a physicochemical assay that allows potency calculation of erythropoietin samples in a precise and accurate manner. The results are summarized as follows: The I-number assay revealed an inter-laboratory precision of CV 3.0%. This retrospective analysis by the author of the CZE data of the (candidate) EPO BRPs has revealed that the bioactivity stated for EPO BRP1 (130.0 IU/μg) should have been stated about 5% higher (“BRP1+5%”=136.5 IU/μg) and the bioactivity stated for EPO BRP2 (130.0 IU/μg) should have been stated about 10% higher (“BRP2+10%”=143.0 IU/μg), and the two new potency values are proposed by the author herewith. The potency assigned for EPO BRP3 (141.1 IU/μg) was without any doubt and therefore confirmed.","PeriodicalId":15534,"journal":{"name":"Journal of Chromatography & Separation Techniques","volume":"1 1","pages":"1-7"},"PeriodicalIF":0.0000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"I-Number Assay and Erythropoietin Potency: Retrospective Capillary Zone Electrophoresis Data Analysis of the Biological Reference Preparations of Erythropoietin\",\"authors\":\"H. P.\",\"doi\":\"10.4172/2157-7064.S8-002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The capillary zone electrophoresis data of erythropoietin reference preparations batch 1 (BRP1), batch 2 (BRP2) and batch 3 (BRP3) of three collaborative studies published in 2004, 2007 and 2015 have retrospectively been analyzed by the author via the I-number assay, a physicochemical assay that allows potency calculation of erythropoietin samples in a precise and accurate manner. The results are summarized as follows: The I-number assay revealed an inter-laboratory precision of CV 3.0%. This retrospective analysis by the author of the CZE data of the (candidate) EPO BRPs has revealed that the bioactivity stated for EPO BRP1 (130.0 IU/μg) should have been stated about 5% higher (“BRP1+5%”=136.5 IU/μg) and the bioactivity stated for EPO BRP2 (130.0 IU/μg) should have been stated about 10% higher (“BRP2+10%”=143.0 IU/μg), and the two new potency values are proposed by the author herewith. The potency assigned for EPO BRP3 (141.1 IU/μg) was without any doubt and therefore confirmed.\",\"PeriodicalId\":15534,\"journal\":{\"name\":\"Journal of Chromatography & Separation Techniques\",\"volume\":\"1 1\",\"pages\":\"1-7\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Chromatography & Separation Techniques\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4172/2157-7064.S8-002\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Chromatography & Separation Techniques","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4172/2157-7064.S8-002","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
I-Number Assay and Erythropoietin Potency: Retrospective Capillary Zone Electrophoresis Data Analysis of the Biological Reference Preparations of Erythropoietin
The capillary zone electrophoresis data of erythropoietin reference preparations batch 1 (BRP1), batch 2 (BRP2) and batch 3 (BRP3) of three collaborative studies published in 2004, 2007 and 2015 have retrospectively been analyzed by the author via the I-number assay, a physicochemical assay that allows potency calculation of erythropoietin samples in a precise and accurate manner. The results are summarized as follows: The I-number assay revealed an inter-laboratory precision of CV 3.0%. This retrospective analysis by the author of the CZE data of the (candidate) EPO BRPs has revealed that the bioactivity stated for EPO BRP1 (130.0 IU/μg) should have been stated about 5% higher (“BRP1+5%”=136.5 IU/μg) and the bioactivity stated for EPO BRP2 (130.0 IU/μg) should have been stated about 10% higher (“BRP2+10%”=143.0 IU/μg), and the two new potency values are proposed by the author herewith. The potency assigned for EPO BRP3 (141.1 IU/μg) was without any doubt and therefore confirmed.
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