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Hermentin P
Hermentin P
Feuerdornweg 8, 35041 Marburg
Germany
Publications
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Research Article
Ibio-Number Assay: A Physicochemical Assay that Predicts the Bioactivity of Erythropoietin with High Precision and Accuracy and May Replace the Mouse Bioassay in the Quality Control of EPO Batch Release
Author(s): Hermentin PHermentin P
The Ibio-number assay, based on capillary zone electrophoresis data of EPO samples, is evaluated as a physicochemical assay that enables to calculate the bioactivity of EPO medicinal products. In part 1, the CZE data of the candidate biological reference preparation EPO cBRP3 of a collaborative study of 10 laboratories (published in 2007) are used to calculate the bioactivity of EPO cBRP3 and to determine the interlaboratory precision of the assay and its accuracy against the stated bioactivity of EPO BRP3. This retrospective analysis by the author revealed an inter-laboratory precision of CV=0.8% (n=9 labs, 1 outlier lab excluded). The bioactivity calculated for cBRP3 (139.6 IU/μg), compared with the stated bioactivity of BRP3 (141.1 IU/μg=100%), provided an accuracy of 98.9%. In part 2, the CZE data of an epoetin alfa drug substance secondary standard and two epoetin alfa drug.. View More»
DOI: 10.4172/2153-2435.1000533