I-Number Assay and Erythropoietin Potency: Retrospective Capillary Zone Electrophoresis Data Analysis of the Biological Reference Preparations of Erythropoietin
| Autor: | Hermentin p |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Chromatography
Chemistry 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Capillary electrophoresis Erythropoietin medicine Retrospective analysis Bioassay Potency 0210 nano-technology medicine.drug |
| Zdroj: | Journal of Chromatography & Separation Techniques. |
| ISSN: | 2157-7064 |
| DOI: | 10.4172/2157-7064.s8-002 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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