Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products.

Leiden Repository

Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products.

Type: Article / Letter to editor
Title: Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products.
Author: Halim, L.A.Brinks, V.Jiskoot, W.Romeijn, S.G.Haselberg, R.Burns, C.Wadhwa, M.Schellekens, H.
Journal Title: Journal of pharmaceutical sciences
Issue: 2
Volume: 105
Start Page: 542
End Page: 550
Pages: 9
Issue Date: 2016
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.
Handle: http://hdl.handle.net/1887/43709
 

Files in this item

Description Size View
application/pdf JournalofPharmaceuticalSciences105(2016)542.pdf 1.800Mb Under embargo Full text at publisher site

This item appears in the following Collection(s)