TY - JOUR
T1 - Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products
AU - Halim, Liem Andhyk
AU - Brinks, Vera
AU - Jiskoot, Wim
AU - Romeijn, Stefan
AU - Haselberg, Rob
AU - Burns, Chris
AU - Wadhwa, Meenu
AU - Schellekens, Huub
N1 - Copyright © 2016. Published by Elsevier Inc.
PY - 2016/2
Y1 - 2016/2
N2 - 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.
AB - 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.
U2 - 10.1016/j.xphs.2015.10.019
DO - 10.1016/j.xphs.2015.10.019
M3 - Article
C2 - 26869417
SN - 0022-3549
VL - 105
SP - 542
EP - 550
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
IS - 2
ER -