Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry
Abstract
The article describes a new method for measurement of monoclonal antibody Eculizumab concentration in human plasma in a range of 3-250 μg/ml. In this method we used an antibody Fab fragment, capable of binding to eculizumab specifically in human plasma. The method uses the biolayer interferometry for determination of Eculizumab concentration without additional tag in the analyzing substances. This method was comparatively validated along with the traditional ELISA. Comparative validation demonstrated that the biolayer interferometry based method has an advantage to the ELISA in such important statistical criteria as an analytical range, accuracy, precision, specificity and selectivity (matrix effect).
About the Authors
V. M. Simonov
International Biotechnology Center «Generium»
Russian Federation
Russian Federation
M. S. Pantushenko
International Biotechnology Center «Generium»
Russian Federation
Staff scientist of department of analytical methods
Russian Federation
Staff scientist of department of analytical methods
A. A. Kazarov
International Biotechnology Center «Generium»
Russian Federation
Head of immunochemistry laboratory of department of analytical methods
Russian Federation
Head of immunochemistry laboratory of department of analytical methods
O. A. Markova
JSC «Generium»
Russian Federation
Head of scientific clinical group of clinical study department
Russian Federation
Head of scientific clinical group of clinical study department
G. N. Poroshin
International Biotechnology Center «Generium»
Russian Federation
Staff scientist of department of analytical methods
Russian Federation
Staff scientist of department of analytical methods
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Review
For citations:
Simonov V.M., Pantushenko M.S., Kazarov A.A., Markova O.A., Poroshin G.N. Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(3):158-164. (In Russ.)
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