Validation of biological activity testing procedure of recombinant human interleukin-7

Autor: T. N. Lutsenko, M. V. Kovalenko, O. Yu. Galkin
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: The Ukrainian Biochemical Journal, Vol 89, Iss 1, Pp 82-89 (2017)
Druh dokumentu: article
ISSN: 2409-4943
2413-5003
DOI: 10.15407/ubj89.01.082
Popis: Validation procedure for method of monitoring the biological activity of reсombinant human interleukin-7 has been developed and conducted according to the requirements of national and international recommendations. This method is based on the ability of recombinant human interleukin-7 to induce proliferation of T lymphocytes. It has been shown that to control the biological activity of recombinant human interleukin-7 peripheral blood mononuclear cells (PBMCs) derived from blood or cell lines can be used. Validation charac­teristics that should be determined depend on the method, type of product or object test/measurement and biological test systems used in research. The validation procedure for the method of control of biological activity of recombinant human interleukin-7 in peripheral blood mononuclear cells showed satisfactory results on all parameters tested such as specificity, accuracy, precision and linearity.
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