Standardization criteria of cell preparation for clinical use
https://doi.org/10.17650/1818-8346-2013-8-4-128-136
Abstract
Using of different cell preparations is an essential part of treatment of many diseases. Production technology and quality control of these products are actually biotechnology research with a variety of the necessary criteria. Quality control system in Russia is missing, so the authors attempt to analyze and adapt FDA and EU criteria for quality control GMP-producing cell preparations. The developed methodology has been tested on cell preparations of allogeneic and autologous mesenchymal stem cells undergoing ex vivo expansion for clinical use in a number of experimental therapeutic programs in pediatric hematologic malignancies.
About the Authors
A. Yu. Ustyugov
Dmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology,
Ministry of Health of Russia
N.N. Pirogov Russian National Research Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
E. Yu. Osipova
Dmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology,
Ministry of Health of Russia
Moscow Institute of Physics and Technology, Ministry of Education and Science
Russian Federation
Russian Federation
S. A. Rumyantsev
Dmitry Rogachev Federal Research Center of Pediatric Hematology, Oncology and Immunology,
Ministry of Health of Russia
N.N. Pirogov Russian National Research Medical University, Ministry of Health of Russia
Moscow Institute of Physics and Technology, Ministry of Education and Science
Russian Federation
Russian Federation
References
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Review
For citations:
Ustyugov A.Yu., Osipova E.Yu., Rumyantsev S.A. Standardization criteria of cell preparation for clinical use. Oncohematology. 2013;8(4):37-45. (In Russ.) https://doi.org/10.17650/1818-8346-2013-8-4-128-136
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