biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2023-23-2-173-180biopreparat-434Research ArticleСтатьиИсследование фармакокинетики биотехнологических препаратов на примере моноклональных антителStudying the pharmacokinetics of biotechnological medicinal products on the example of monoclonal antibodieshttps://orcid.org/0000-0002-8232-6682СмирновВ. В.SmirnovV. V.

Смирнов Валерий Валерьевич, д-р фарм. наук, доц.

Каширское шоссе, д. 24, Москва, 115522;

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Valery V. Smirnov, Dr. Sci. (Pharm.), Associate Professor

24 Kashirskoe Hwy, Moscow 115522;

8/2 Trubetskaya St., Moscow 119991

vall@mail.mipt.ruhttps://orcid.org/0000-0002-3339-2608ПетуховаО. А.PetukhovaO. A.

Петухова Ольга Андреевна

Каширское шоссе, д. 24, Москва, 115522

Olga A. Petukhova

24 Kashirskoe Hwy, Moscow 115522

tashirik@mail.ruhttps://orcid.org/0000-0002-6460-9427ФилатовА. В.FilatovA. V.

Филатов Александр Васильевич, д-р биол. наук, проф.

Каширское шоссе, д. 24, Москва, 115522

Alexander V. Filatov, Dr. Sci. (Biol.), Professor

24 Kashirskoe Hwy, Moscow 115522

avfilat@yandex.ruhttps://orcid.org/0000-0003-1878-4467КудлайД. А.KudlayD. A.

Кудлай Дмитрий Анатольевич, д-р мед. наук

Каширское шоссе, д. 24, Москва, 115522;

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Dmitry A. Kudlay, Dr. Sci. (Med.)

24 Kashirskoe Hwy, Moscow 115522;

8/2 Trubetskaya St., Moscow 119991

D624254@gmail.comhttps://orcid.org/0000-0003-4961-9640ХаитовМ. Р.KhaitovM. R.

Хаитов Муса Рахимович, д-р мед. наук, проф., член-корр. РАН

Каширское шоссе, д. 24, Москва, 115522

Musa R. Khaitov, Dr. Sci. (Med.), Professor, Corr. Member of RAS

24 Kashirskoe Hwy, Moscow 115522

mr.khaitov@nrcii.ruФедеральное государственное бюджетное учреждение «Государственный научный центр «Институт иммунологии» Федерального медико-биологического агентства России; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» (Сеченовский Университет) Министерства здравоохранения Российской ФедерацииРоссияNRC Institute of Immunology of the FMBA of Russia; I. M. Sechenov First Moscow State Medical University (Sechenov University)Russian FederationФедеральное государственное бюджетное учреждение «Государственный научный центр «Институт иммунологии» Федерального медико-биологического агентства РоссииРоссияNRC Institute of Immunology of the FMBA of RussiaRussian Federation202303052023232От традиционных биологических к высокотехнологичным лекарственным препаратам: вопросы разработки и применения173180Copyright © Смирнов В.В., Петухова О.А., Филатов А.В., Кудлай Д.А., Хаитов М.Р., 20232023Смирнов В.В., Петухова О.А., Филатов А.В., Кудлай Д.А., Хаитов М.Р.Smirnov V.V., Petukhova O.A., Filatov A.V., Kudlay D.A., Khaitov M.R.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/434

Терапевтические моноклональные антитела (МкАт) являются одним из самых быстроразвивающихся классов лекарственных средств, которые разрабатываются для лечения многих патологий, включая рак, аутоиммунные и инфекционные заболевания. Учитывая большое количество находящихся в настоящее время в разработке МкАт и сохраняющийся интерес со стороны фармацевтических компаний, ожидается, что рынок МкАт будет продолжать расти и в последующие годы. Для максимизации как терапевтической пользы, так и безопасности препаратов этого класса крайне важно, чтобы их фармакологические свойства были тщательно охарактеризованы.

Цель работы — анализ литературных данных о подходах в изучении фармакокинетических параметров моноклональных антител.

Представлены данные об основных физико-химических и фармакологических свойствах МкАт. Проведен сравнительный анализ характеристик МкАт и низкомолекулярных лекарственных веществ. Показано влияние на фармакокинетические параметры МкАт различных факторов, таких как способ введения, гидрофильность и заряд МкАт, индивидуальные особенности пациентов (масса тела, уровень альбумина в плазме крови, генетические особенности и др.), совместное применение с другими лекарственными средствами. Оценена роль межиндивидуальной и внутрииндивидуальной вариабельности фармакокинетических параметров МкАт. Сделан вывод о том, что в условиях стремительных темпов разработки препаратов данной группы и появления новых перспективных молекул особо важное значение приобретает необходимость подробного изучения и оптимизации фармакокинетических и фармакодинамических свойств для повышения как терапевтической пользы, так и безопасности препаратов класса МкАт.

Therapeutic monoclonal antibodies (mAbs), which are developed to treat many pathologies, including cancer, autoimmune and infectious diseases, are one of the fastest growing classes of medicinal products. Given the large number of mAbs in the pipeline and continued interest from pharmaceutical companies, the mAb market is expected to continue to grow in the coming years. To maximise both the therapeutic benefit and the safety of medicinal products in this class, it is essential that their pharmacological properties be carefully characterised and understood.

The aim of the study was to analyse literature data on approaches to studying the pharmacokinetics of mAbs. This review presents data on the main physicochemical and pharmacological properties of mAbs and compares them with small molecules. The article describes the influence of various factors on mAb pharmacokinetics.

For example, such factors include the method of administration, hydrophilicity, and charge of the mAb, individual characteristics of the patient (body weight, plasma albumin levels, genetic characteristics, etc.), and concurrent administration of other medicinal products. The authors evaluated the role of intra- and inter-individual variability of pharmacokinetic parameters. The rapid development of this group of medicinal products and the emergence of new promising molecules are indicative of the need to study the pharmacokinetics and pharmacodynamics of mAbs in detail and to maximise both the therapeutic benefit and the safety of the medicinal products in this class.

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