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Expert Assessment of In Vitro Potency Assays for Monoclonal Antibody Preparations

INTRODUCTION. The quality control of biotechnological medicinal products requires a range of biological assay procedures. The development of bioassays for potency determination is a complex process that should comply with the requirements set forth in regulatory standards. For adequate reproducibili...

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Principais autores: N. A. Alpatova, O. V. Golovinskaya, M. L. Baykova, S. L. Lysikova, L. A. Gaiderova
Formato: Artigo
Idioma:Russo
Publicado em: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2025-02-01
coleção:Регуляторные исследования и экспертиза лекарственных средств
Assuntos:
моноклональные антитела
лекарственные препараты
оценка качества лекарственных препаратов
биологические методики in vitro
нормативная документация
биологическая активность
специфическая активность
культуры клеток
Acesso em linha:https://www.vedomostincesmp.ru/jour/article/view/733
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