biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2022-22-2-154-169biopreparat-393Research ArticleОБЗОРЫREVIEWSПерспективы применения метода ионной хроматографии в оценке качества биологических лекарственных препаратовProspects for ion chromatography in quality assessment of biologicalshttps://orcid.org/0000-0003-0026-7365МинероА. С.MineroA. S.

Минеро Анастасия Сальвадоровна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Anastasia S. Minero

8/2 Petrovsky Blvd, Moscow 127051

minero@expmed.ruhttps://orcid.org/0000-0003-0729-530XРуноваО. Б.RunovaO. B.

Рунова Ольга Борисовна, канд. хим. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Olga B. Runova, Cand. Sci. (Chem.)

8/2 Petrovsky Blvd, Moscow 127051

runova@expmed.ruhttps://orcid.org/0000-0001-5432-1887УстинниковаО. Б.UstinnikovaO. B.

Устинникова Ольга Борисовна, канд. биол. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Olga B. Ustinnikova, Cand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051

ustinnikova@expmed.ruhttps://orcid.org/0000-0003-2132-0962МовсесянцА. А.MovsesyantsA. A.

Мовсесянц Арташес Авакович, д-р мед. наук, проф.

Петровский б-р, д. 8, стр. 2, Москва, 127051

Artashes A. Movsesyants, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051

movsesyants@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202214062022222154169Copyright © Минеро А.С., Рунова О.Б., Устинникова О.Б., Мовсесянц А.А., 20222022Минеро А.С., Рунова О.Б., Устинникова О.Б., Мовсесянц А.А.Minero A.S., Runova O.B., Ustinnikova O.B., Movsesyants A.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/393

Количественная характеристика вспомогательных веществ, входящих в состав биологических лекарственных препаратов (БЛП), является важной составляющей процесса подтверждения качества как на уровне готового продукта, так и на стадиях промежуточных продуктов, в том числе фармацевтических субстанций. Метод ионной хроматографии с амперометрическим и кондуктометрическим способами детектирования продуктов разделения обладает рядом достоинств, основным из которых является возможность прямого определения малолетучих соединений, не имеющих хромофорных групп и не обладающих собственной флуоресценцией. Цель работы — на основании сравнительного анализа метода ионной хроматографии и альтернативных методов определить перспективные области применения метода ионной хроматографии в оценке качества БЛП. На основании результатов проведенного анализа нормативной документации и данных литературы обобщены методы количественного определения вспомогательных веществ с ионной структурой в БЛП. Рассмотрены возможности применения метода ионной хроматографии для определения основного действующего вещества в полисахаридных вакцинах и вспомогательных веществ в БЛП. Показана целесообразность применения метода ионной хроматографии для одновременного количественного определения катионов (аммоний, кальций, магний) и анионов (хлориды, сульфаты, нитраты) в растворителе для лиофилизированных БЛП, для оценки качества действующего вещества БЛП (количественное определение полисахарида в полисахаридных вакцинах, гликопрофиль гликозилированных протеинов и т.д.), а также при определении нескольких стабилизаторов углеводной природы БЛП одной методикой. Сделан вывод, что ионообменная хроматография с кондуктометрическим и амперометрическим детектированием при оценке качества БЛП в ближайшей перспективе может занять лидирующие позиции в количественной оценке вспомогательных веществ с ионной структурой, стабилизаторов углеводной природы и основного действующего вещества — полисахарида в полисахаридных вакцинах, в том числе вакцинах национального календаря профилактических прививок.

Quantitative characterisation of excipients in biologicals is an important part of the quality assurance process both at the level of finished products and intermediates, as well as active pharmaceutical ingredients. Ion chromatography with amperometric and conductometric detection of separation products has a number of advantages. The main of the advantages is the possibility of direct determination of semivolatile compounds that have neither chromophoric groups, nor intrinsic fluorescence. The aim of this study was to compare ion chromatography with alternative methods in order to identify promising areas for its use in assessing the quality of biologicals. The authors analysed regulatory documents and literature and summarised the methods applied for quantitative determination of ionic excipients in biological medicinal products. The authors investigated the possibility of using ion chromatography for determination of the main active pharmaceutical ingredient in polysaccharide vaccines and excipients in biologicals. The study demonstrated the feasibility of ion chromatography for simultaneous quantitation of cations (ammonium, calcium, magnesium) and anions (chlorides, sulfates, nitrates) in reconstitution solvents for lyophilised biologicals; quality assessment of active pharmaceutical ingredients in biologicals (quantitative analysis of polysaccharides in polysaccharide vaccines, profiling of glycosylated proteins, etc.); and determination of several carbohydrate stabilisers in biologicals with the same analytical procedure. According to the conclusions, ion-exchange chromatography with conductometric and amperometric detection, aimed at quality assessment of biological products, can shortly take a leading position in quantitation of ionic excipients, carbohydrate stabilisers, and main active ingredients (polysaccharides) in polysaccharide vaccines, including the vaccines in the immunisation schedule.

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The authors declare that there are no conflicts of interest present.