Classification of Cell Therapy Products by Cell Manipulation Degree and Functions Performed: Analysis of International Regulatory Approaches

Classification of Cell Therapy Products by Cell Manipulation Degree and Functions Performed: Analysis of International Regulatory Approaches

INTRODUCTION. The degree of processing (manipulation) of cells included in a cell product and the functions performed after administration (homologous/non-homologous use) determine the classification of the cell product as a transplant or an advanced therapy medicinal product (ATMP) and, hence, the...

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Bibliographic Details
Main Authors: M. A. Vodyakova, N. S. Pokrovsky, I. S. Semenova, V. A. Merkulov, E. V. Melnikova
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’) 2024-11-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
stromal vascular fraction
fat tissue
advanced therapy medicinal product
atmp
legal regulation
quality control
degree of cell manipulation
cell product
minimal manipulation
homologous use
non-homologous use
Online Access:https://www.vedomostincesmp.ru/jour/article/view/710
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