Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products
| Autor: | Halim, Liem Andhyk, Brinks, Vera, Jiskoot, Wim, Romeijn, Stefan, Haselberg, Rob, Burns, Chris, Wadhwa, Meenu, Schellekens, Huub, Sub General Pharmaceutics, Sub Biotechnological drugs, Sub Biomolecular analysis, Pharmaceutics |
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| Přispěvatelé: | BioAnalytical Chemistry, AIMMS, Sub General Pharmaceutics, Sub Biotechnological drugs, Sub Biomolecular analysis, Pharmaceutics |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Chemistry Pharmaceutical media_common.quotation_subject Pharmaceutical Science Mice 03 medical and health sciences 0302 clinical medicine Biosimilar Pharmaceuticals Capillary electrophoresis medicine Animals Humans Potency Quality (business) Erythropoietin media_common Gel electrophoresis Mice Inbred BALB C Chromatography Chemistry Epoetin alfa Biosimilar Recombinant Proteins Epoetin Alfa 030104 developmental biology Therapeutic Equivalency 030220 oncology & carcinogenesis Female medicine.drug |
| Zdroj: | Journal of Pharmaceutical Sciences, 105(2), 542. John Wiley and Sons Inc. Andhyk Halim, L, Brinks, V, Jiskoot, W, Romeijn, S, Haselberg, R, Burns, C, Wadhwa, M & Schellekens, H 2016, ' Quality and barch-to-batch consistency of original and biosimilar epoetin products. ', Journal of Pharmaceutical Sciences, vol. 105, pp. 542-550 . https://doi.org/10.1016/j.xphs.2015.10.019 Journal of Pharmaceutical Sciences, 105, 542-550. John Wiley and Sons Inc. |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2015.10.019 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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