Quality of Original and Biosimilar Epoetin Products

Autor: Brinks, V., Hawe, A., Basmeleh, A.H.H., Joachin-Rodriguez, L., Haselberg, R., Somsen, G.W., Jiskoot, W., Schellekens, H., Advanced drug delivery systems/drug targeting, Biomolecular Analysis, Innovation Studies, Farmaceutische Analyse, Pharmaceutics, Sub Biotechnological drugs, Sub Biomolecular analysis, Dep Farmaceutische wetenschappen
Přispěvatelé: BioAnalytical Chemistry, AIMMS, Advanced drug delivery systems/drug targeting, Biomolecular Analysis, Innovation Studies, Farmaceutische Analyse, Pharmaceutics, Sub Biotechnological drugs, Sub Biomolecular analysis, Dep Farmaceutische wetenschappen
Jazyk: angličtina
Rok vydání: 2011
Předmět:
protein characterization
Drugmisbruik en verslaving
Therapeutic equivalency
media_common.quotation_subject
Pharmacology toxicology
Pharmaceutical Science
Enzyme-Linked Immunosorbent Assay
Pharmacology
immunogenicity
Biomedische technologie en medicijnen
Farmacie/Biofarmaceutische wetenschappen (FARM)
Mice
Pharmaceutical technology
hemic and lymphatic diseases
Medical technology
Animals
Protein Isoforms
Medicine
Potency
Quality (business)
Pharmacology (medical)
Bescherming en bevordering van de menselijke gezondheid
recombinant human erythropoietin
Erythropoietin
media_common
Biological Products
business.industry
Organic Chemistry
Farmacie(FARM)
Electrophoresis
Capillary
Biosimilar
Recombinant Proteins
Therapeutic Equivalency
Chromatography
Gel
Molecular Medicine
Electrophoresis
Polyacrylamide Gel
Public Health
biosimilar
business
Analytical chemistry
Research Paper
medicine.drug
Biotechnology
Zdroj: Brinks, V, Hawe, A, Basmeleh, A H H, Joachin-Rodriguez, L, Haselberg, R, Somsen, G W, Jiskoot, W & Schellekens, H 2011, ' Quality of Original and Biosimilar Epoetin Products ', Pharmaceutical research, vol. 28, no. 2, pp. 386-393 . https://doi.org/10.1007/s11095-010-0288-2
Pharmaceutical research, 28(2), 386-393. Springer New York
Pharmaceutical Research, 28(2), 386. Springer New York LLC
Pharmaceutical Research
ISSN: 0724-8741
DOI: 10.1007/s11095-010-0288-2
Popis: Purpose To compare the quality of therapeutic erythropoietin (EPO) products, including two biosimilars, with respect to content, aggregation, isoform profile and potency. Methods Two original products, Eprex (epoetin alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alfa) and Retacrit (epoetin zeta), were compared using (1) high performance size exclusion chromatography, (2) ELISA, (3) SDS-PAGE, (4) capillary zone electrophoresis and (5) in-vivo potency. Results Tested EPO products differed in content, isoform composition, and potency. Conclusion Of the tested products, the biosimilars have the same or even better quality as the originals. Especially, the potency of originals may significantly differ from the value on the label.
Databáze: OpenAIRE
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