Ukr.Biochem.J. 2017; Volume 89, Issue 1, Jan-Feb, pp. 82-89


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

T. N. Lutsenko1,2, M. V. Kovalenko3, O. Yu. Galkin2

2National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”;
3Institute of Molecular Biology and Genetics of the National
Academy of Sciences of Ukraine, Kyiv;

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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