Title:Biochemical and Biological Quality Control of Two Recombinant Human Erythropoietin Biosimilar Products
Volume: 13
Issue: 6
Author(s): Rym Hassiki, Jamila Behi, Nadia Ben Said, Lassaad Boujbel and Balkiss Bouhaouala-Zahar *
Affiliation:
- Laboratory of Venoms and Therapeutic Molecules, Institute Pasteur of Tunis, Tunis El Manar University, 13 Place Pasteur, PB. 74, Tunis 1002,Tunisia
Keywords:
Recombinant human erythropoietin, biosimilars, European Pharmacopeia, biochemical and structural characterization,
potency, purity, similarity.
Abstract: Background: The control of structural variations of therapeutic proteins is a big challenge
requiring sophistic and accurate analytical tools for the analysis of the conformational stability of the
final formulations.
Methods: This paper reports the biochemical, structural and biological tests used to evaluate the identity
and purity of a recombinant human erythropoietin alfa, used in the formulation of the first Tunisian
approved biosimilar (Epomax 2000 I.U/mL) and the comparative assessment between this final product
and an equivalent commercialized biosimilar in Tunisia with respect to the protein content, physiochemical
integrity, immunogenicity and biological activity.
Results: Our results demonstrated that Epomax showed high and similar consistence in total protein content
(2.605 mg/mL for Bradford assay), isotonicity (271 mOsm/kg for Osmolarity measurement), purity (a
single band at 37.40 kDa for western blot analysis), and potency (1724.00 I.U./mL for in vivo bioassay)
when compared to the commercialized biosimilar product (2.969 mg/mL for Bradford assay, 291 mOsm/kg
for Osmolarity measurement, a single band at 36.29 kDa and 1690.79 I.U./mL for in vivo bioassay).
Conclusion: The analyzed erythropoietin raw material is highly pure and in compliance with the specifications
of the European Pharmacopeia. As well as, the final product Epomax has shown highly comparability
with the commercialized reference product.
