Abstract
Flow cytometry is the most common method of identification and quantitation of cell surface markers. Flow cytometry can be used for cell counting and characterization of cell types and subtypes by labeling cells with fluorochrome-conjugated monoclonal antibodies. Manufacturers of human cell-based medicinal products have accumulated significant experience in flow cytometry and developed a large number of procedures that can be validated and included into cell products specifications. The present review summarises the experience gained with the use of flow cytometry for characterization of human cell lines used to develop cell therapy products. Since all biomedical cell products (BMCPs) have a cellular component, it will be necessary to use the flow cytometry method for identification testing of BMCPs during evaluation of their quality.
Highlights
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 8/2 Petrovsky boulevard, Moscow 127051, Russian Federation
Flow cytometry can be used for cell counting and characterization of cell types and subtypes by labeling cells with fluorochrome-conjugated monoclonal antibodies
The present review summarises the experience gained with the use of flow cytometry for characterization of human cell lines used to develop cell therapy products
Summary
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 8/2 Petrovsky boulevard, Moscow 127051, Russian Federation. Since all biomedical cell products (BMCPs) have a cellular component, it will be necessary to use the flow cytometry method for identification testing of BMCPs during evaluation of their quality. В Европейском союзе и США при определении показателей качества и составлении спецификаций препаратов для клеточной терапии метод проточной цитометрии используется для определения иммунофенотипического профиля, характеризующего чистоту, подлинность и эффективность клеточного продукта [3, 4]. На сегодняшний день использование проточной цитометрии считается обязательным, но недостаточным для доказательства подлинности препарата, применяемого для клеточной терапии [3, 7, 8]. Одним из ключевых методов оценки показателей качества биомедицинских клеточных продуктов (БМКП), безусловно, будет являться метод проточной цитометрии [9]. Цель работы — оценить наработанный отечественными и зарубежными учеными опыт стандартизации клеточных линий с использованием метода проточной цитометрии, возможные проблемы при его использовании и подходы к их решению
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