Development and validation of a method for determination of Eculizumab concentration in human plasma by biolayer interferometry

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)

Spectroscopy of superheavy hydrogen isotopes

The superheavy hydrogen isotopes 4H and 5H have been investigated in the stopped pion absorption on 9Be. Three states of 4H were proposed in the reaction channel 9Be( π{ - }, dt)X. Four states of 5H were proposed in the reaction channels 9Be(π{ - }, pt)X and 9Be(π{ - }, dt)X. The excited states of 5H can decay into free nucleons

Search for superheavy hydrogen isotopes

Experimental search for superheavy hydrogen isotopes 6H and 7H was performed in the stopped pion absorption on 9Be and 11B nuclei. The structures in the missing-mass spectra were observed in the reaction channels 9Be(π-, pd )X and 11B(π-, p4He)X . Four states of 6H were proposed. Evidences for 7H formation were obtained in the reaction channels 9Be(π-, pp)X and 11B(π-, p3He)X

Разработка и валидация методики определения концентрации экулизумаба в плазме крови человека с применением технологии биослойной интерферометрии

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).Разработана и валидирована методика определения концентрации препарата моноклонального терапевтического антитела экулизумаб в плазме крови человека в диапазоне концентраций 3-250 мкг/мл. Методика основана на взаимодействии иммобилизованного Fab-фрагмента антитела, специфичного к экулизумабу в образце плазмы крови. Методика использует принцип биослойной интерферометрии, позволяющий без внесения дополнительных меток оценить концентрацию анализируемого вещества. Результаты валидации методики сопоставлялись с результатами валидации альтернативной методики на основе иммуноферментного анализа. По итогам исследования показано преимущество методики на основе биослойной интерферометрии по основным метрологическим характеристикам - аналитическому диапазону, правильности, прецизионности и селективности