Monoclonal antibodies: Development of universal (platform) methods for the assessment of high and low-molecular weight impurities

Monoclonal antibodies: Development of universal (platform) methods for the assessment of high and low-molecular weight impurities

INTRODUCTION. The development of unified techniques for quality control monoclonal antibodies (mAb) is one of the challenges for mAbs quality standardization.AIM. This study aimed to develop and analyse the possibility of using platform (universal) techniques for estimating the impurity content of h...

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Bibliographic Details
Main Authors: O. A. Vaganova, R. S. Smirnov, S. A. Lenin, K. S. Funtashev, A. A. Kostromskih, A. S. Peregudova, D. A. Kadykova, V. A. Merkulov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2025-07-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
monoclonal antibody
мав
capillary electrophoresis
size exclusion chromatography
quality of medicines
normative document
high performance liquid chromatography
platform technique
universal technique
Online Access:https://www.vedomostincesmp.ru/jour/article/view/759
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https://www.vedomostincesmp.ru/jour/article/view/759

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