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Recombinant Interferons Beta-1a and Beta-1b: Protein Structural Features and Problematic Issues with Identity Confirmation

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Pharmaceutical Chemistry Journal Aims and scope

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.

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Authors and Affiliations

  1. Scientific Centre for Expert Evaluation of Medicinal Products, 8/2 Petrovskii Blvd., Moscow, 127051, Russia

    E. O. Goloshchapova, O. B. Runova & O. B. Ustinnikova

Authors
  1. E. O. Goloshchapova
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  2. O. B. Runova
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  3. O. B. Ustinnikova
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Correspondence to E. O. Goloshchapova.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 8, pp. 61 – 64, August, 2018.

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Goloshchapova, E.O., Runova, O.B. & Ustinnikova, O.B. Recombinant Interferons Beta-1a and Beta-1b: Protein Structural Features and Problematic Issues with Identity Confirmation. Pharm Chem J 52, 749–752 (2018). https://doi.org/10.1007/s11094-018-1892-4

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  • DOI: https://doi.org/10.1007/s11094-018-1892-4

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