Recombinant Interferons Beta-1a and Beta-1b: Protein Structural Features and Problematic Issues with Identity Confirmation
- Authors: Goloshchapova E.O.1, Runova O.B.1, Ustinnikova O.B.1
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Affiliations:
- Scientific Centre for Expert Evaluation of Medicinal Products
- Issue: Vol 52, No 8 (2018)
- Pages: 749-752
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245441
- DOI: https://doi.org/10.1007/s11094-018-1892-4
- ID: 245441
Cite item
Abstract
Drugs based on recombinant interferons β are in high demand in clinical practice for first-line therapy of multiple sclerosis. Drugs based on recombinant interferons β-1a and β-1b are registered in the Russian Federation. These proteins have different production technologies and, hence, structures. Recombinant interferon β-1a is a glycosylated protein with a structure close to that of endogenous human interferon. Recombinant interferon β-1b is a non-glycosylated protein that differs by two amino-acid residues from interferon β-1a. These structural features influence the biological properties of drugs based on interferons β-1a and β-1b, in particular, their clinical efficacy, side effects, and induction intensity of neutralizing antibodies. For this reason, a laboratory pharmaceutical examination of the drug quality of interferons β should include confirmation of the specific biological activity and the correspondence of the target protein to the claimed structure. However, domestic and international pharmacopoeial requirements for quality assessment of interferon-β-based drugs are not currently fully adequate. Formulation of unified domestic requirements would allow the registration process to be optimized and provide a basis for harmonization of domestic and international requirements.
About the authors
E. O. Goloshchapova
Scientific Centre for Expert Evaluation of Medicinal Products
Author for correspondence.
Email: Goloshapova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
O. B. Runova
Scientific Centre for Expert Evaluation of Medicinal Products
Email: Goloshapova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
O. B. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Email: Goloshapova@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051