| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 2484254 | Journal of Pharmaceutical Sciences | 2016 | 9 Pages |
Abstract
Comprehensive physicochemical characterization and biological assays are essential parts in assessing quality attributes of biologicals. Here, we compared the quality of different marketed recombinant human erythropoietin (epoetin) products: originators, Eprex and NeoRecormon as well as 2 biosimilars, Retacrit and Binocrit. In addition, assessment of batch-to-batch variability was included by collecting 2 or more batches of each product. Common assays which included sodium dodecyl sulfate-polyacrylamide gel electrophoresis, high-performance size-exclusion chromatography, asymmetrical flow field-flow fractionation, capillary zone electrophoresis, and potency testing were used. Of the tested products and among batches of single products, variations in epoetin content, isoform profiles, and potency were found. Ultimately, this study demonstrated the high quality of epoetin products with some degree of variation among products and batches, confirming the “similar but not identical” paradigm of biologicals.
Keywords
Related Topics
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Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Liem Andhyk Halim, Vera Brinks, Wim Jiskoot, Stefan Romeijn, Rob Haselberg, Chris Burns, Meenu Wadhwa, Huub Schellekens,