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

Autor:	M. A. Zhuchenko, A. A. Ishchenko, Yu. Yu. Rassulin, A. D. Askretkov, D. V. Kapustin, N. V. Orlova, Yu. A. Seregin, A. I. Prostyakova, D. I. Zybin
Rok vydání:	2021
Předmět:	Pharmacology Drug Chromatography medicine.drug_class Chemistry Isoelectric focusing media_common.quotation_subject Biosimilar Monoclonal antibody medicine.disease_cause Electrophoresis Drug Discovery medicine Degradation (geology) Irradiation Oxidative stress media_common
Zdroj:	Pharmaceutical Chemistry Journal. 55:732-739
ISSN:	1573-9031 0091-150X
DOI:	10.1007/s11094-021-02485-y
Popis:	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.
Databáze:	OpenAIRE
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