SpringerLink
Log in

Comparative Study of the Stability of Eculizumab Biosimilar and the Original Drug under Extreme pH, Oxidative Stress, and UV Irradiation Conditions

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
  • Published:
Pharmaceutical Chemistry Journal Aims and scope

A study of the degradation profiles of drugs based on recombinant monoclonal antibodies under stress conditions made it possible to determine the dynamics and mechanisms of degradation processes, to identify drug degradation products, and to reveal differences in the stability of biosimilar drugs for relatively short times. A strategy for accelerated (35 d) stability assessment under stress conditions of the original product Soliris® (Switzerland) and its biosimilar PRK-001 (Russia) was proposed. Their degradation profiles after exposure to extreme pH, oxidative stress, and UV radiation were studied. Antibody fragments were analyzed using size-exclusion chromatography, capillary isoelectric focusing, electrophoresis, and mass spectrometry. Both products showed similar degradation profiles and similar changes in isoform contents.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price includes VAT (United Kingdom)

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1.
Fig. 2.
Fig. 3.
Fig. 4.
Fig. 5.
Fig. 6.
Fig. 7.
Fig. 8.

Similar content being viewed by others

References

  1. WHO Technical Report Series, No. 863, Annex 5,World Health Organization (1996).

  2. Decision of the Council of the Eurasian Economic Commission No. 88 (2016).

  3. Decision of the Council of the Eurasian Economic Commission No. 89 (2016).

  4. Decision of the Eurasian Economic Commission Board No. 69 (2018).

  5. Resolution No. 78, The Eurasian Economic Commission (2016).

  6. ICH Topic Q1B Photostability Testing of New Active Substances and Medicinal Products, European Medicines Agency (1998).

  7. ICH Q1A (R2). European Medicines Agency (2003).

  8. K. Waterman and R. Adami, Int. J. Pharm., 293, 101 – 125 (2005).

    Article  CAS  Google Scholar 

  9. K. Waterman, AAPS PharmSciTech., 12, No. 3, 932 – 937 (2011).

    Article  CAS  Google Scholar 

  10. WHO Meeting Report, Switzerland (2006).

  11. M. Rios, Abstracts of the 12th Annual BioProcess Int. Conf., Boston (2015).

  12. W. Jiskoot, E. C. Beuvery, A. A. De Koning, et al., Pharm. Res., 7(12), 1234 – 1241 (1990).

    Article  CAS  Google Scholar 

  13. M. Paborji, N. L. Pochopin, W. P. Coppola, et al., Pharm Res., 11(5), 764 – 771 (1994).

    Article  CAS  Google Scholar 

  14. P. Arosio, S. Rima, and M. Morbidelli, Pharm Res., 30(3), 641 – 654 (2013).

    Article  CAS  Google Scholar 

  15. D. K. Sharma, P. Oma, M. J. Pollo, et al., J. Pharm Sci., 99(6), 2628 – 2642 (2010).

    Article  CAS  Google Scholar 

  16. G. Gaza-Bulseco and H. Liu, Pharm Res., 25(8), 1881 – 1890 (2008).

    Article  CAS  Google Scholar 

  17. S. L. Cohen, C. Price, and J. Vlasak, J. Am. Chem. Soc., 129(22), 6976 – 6977 (2007).

    Article  CAS  Google Scholar 

  18. A. J. Cordoba, B. J. Shyong, D. Breen, et al., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 818(2), 115 – 121 (2005).

    Article  CAS  Google Scholar 

  19. T. **ang, E. Lundell, Z. Sun, et al., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 858(1–2), 254 – 262 (2007).

    Article  CAS  Google Scholar 

  20. E. Folzer, K. Diepold, and K. Bomans, J. Pharm. Sci., 104(9), 2824 – 2831 (2015).

    Article  CAS  Google Scholar 

  21. C. K. Nowak, J. Cheung, and M. Dellatore, mAbs, 9(8), 1217 – 1230 (2017).

    Article  CAS  Google Scholar 

  22. D. Creed, Photochem. Photobiol., 39(4), 537 – 562 (1984).

    Article  CAS  Google Scholar 

  23. L. A. Holt, B. Milligan, D. E. Rivett, et al., Biochim. Biophys. Acta, 499(1), 131 – 138 (1977).

    Article  CAS  Google Scholar 

  24. B. A. Kerwin, R. L Remmele, et al., J. Pharm. Sci., 96(6), 1468 – 1479 (2007).

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. MIREA, Russian Technological University (M. V. Lomonosov Institute of Fine Chemical Technology), 86 Prosp. Vernadskogo, Moscow, 119571, Russia

    D. I. Zybin & A. A. Ishchenko

  2. Pharmapark LLC, 8/1 Nauchnyi Prosp., Moscow, 117246, Russia

    D. I. Zybin, M. A. Zhuchenko, Yu. Yu. Rassulin, A. D. Askretkov & Yu. A. Seregin

  3. Shemyakin–Ovchinnikov Institute of Bioorganic Chemistry, 16/10 Miklukho-Maklaya St., Moscow, 117997, Russia

    A. I. Prostyakova & D. V. Kapustin

  4. State Research Institute of Genetics and Selection of Industrial Microorganisms, National Research Center Kurchatov Institute, 1 Dorozhnyi Proezd, Moscow, 117545, Russia

    N. V. Orlova

Authors
  1. D. I. Zybin
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. A. Zhuchenko
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yu. Yu. Rassulin
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. A. D. Askretkov
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. A. I. Prostyakova
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. A. A. Ishchenko
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. N. V. Orlova
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Yu. A. Seregin
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. D. V. Kapustin
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to A. I. Prostyakova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 7, pp. 47 – 54, July, 2021.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zybin, D.I., Zhuchenko, M.A., Rassulin, Y.Y. et al. Comparative Study of the Stability of Eculizumab Biosimilar and the Original Drug under Extreme pH, Oxidative Stress, and UV Irradiation Conditions. Pharm Chem J 55, 732–739 (2021). https://doi.org/10.1007/s11094-021-02485-y

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11094-021-02485-y

Keywords

Search

Navigation