Abstract
Bioanalytical methods are applied at the development and test of drugs as well as at the step of pharmaceutic products issue. Drugs and excipients quality estimation is made by means of precise and reproducible methods. Accuracy and reproducibility of a method is established during validation which is obligatory for medicine registration. The principal task of method validation is experimental evidence of its suitability for the objectives to be achieved. Validation of bioanalytical methods is one of the elements of the whole medicine production validation [1, 2]. The aim of research : to validate a method for determination of specific anti-hemolytic activity of eculizumab developed in LCC “IBC Generium”. Materials and methods: eculizumab, antibody-sensitized chicken erythrocytes, complement-containing human serum. Results. We demonstrated the specificity of the method and its correspondence to criteria of accuracy (103.0±1.4)%, robustness (CV – 11.5%), repeatability (CV – (4.9±0.9)%), reproducibility (CV – (3.5±0.4)%), and linearity (k -1.0275; R2 – 0.9975) during validation. The system validity (equipment, materials, analytical operations and analyzed samples) was confirmed for true results obtaining during validation. Results discussion. Experimental evidence of suitability of the method for eculizumab specific activity assessment was obtained in course of validation. The simplicity of the method allows obtaining accurate results in other laboratories. The developed method can be used not only for specific activity of Soliris determination but also for other pharmaceutical substances and drugs based on antibodies specific to human complement C5.
Highlights
Efficiency and safety of drugs are guaranteed by their correspondence to national and international quality standards
We demonstrated the specificity of the method and its correspondence to criteria of accuracy (103.0±1.4)%, robustness (CV – 11.5%), repeatability (CV – (4.9±0.9)%), reproducibility (CV – (3.5±0.4)%), and linearity (k -1.0275; R2 – 0.9975) during validation
The conclusion about medicine quality depends from the method quality at a significant rate; it is necessary to assess suitability of analytical methods using qualification procedure or full validation [1, 3]
Summary
Efficiency and safety of drugs are guaranteed by their correspondence to national and international quality standards. Correspondence of drugs quality to the restricted requirements is established by different methods. The main task of method validation is experimental confirmation of its appliдоказательство пригодности ее применения для достижения заявленной цели. Целью исследования была разработка и валидация метода оценки специфической активности ЛС экулизумаб (Солирис). Солирис применяется для лечения пароксизмальной ночной гемоглобинурии (ПНГ). ПНГ – это очень редкое заболевание крови, обусловленное экспансией одного или нескольких клонов гемопоэтических стволовых кроветворных клеток с соматической мутацией PIG-A гена [4, 5]. В 58% случаев причиной смерти пациентов с ПНГ являются тромбозы, хроническая болезнь почек, геморрагические осложнения на фоне тромбоцитопении [5, 6]
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