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Information × Registration Number 0214U005911, 0111U010258 , R & D reports Title Improvement of technology of purification of immunoglobulins for intravenous application from ballast peptides. popup.stage_title Head Timchenko A.S., Registration Date 10-04-2015 Organization Kiev Research Institute of Haematolojy and Blood Transfusion popup.description2 Object of research -- the human intravenous immunoglobulin. Aim of research - to develop the technology for obtaining purified from ballast proteins thе intravenous immunoglobulins. Methods of research - the method of fractionation of blood plasma by Cohn, chromatography, immunochemical, immunologic, biochemical, biological, statistic. By means of the improvement technology it is obtained six series of the IVIG. It is investigated the main physical and chemical properties, molecular parameters, immunology and haematology safety, anticomplement activity, biological properties and purity degree of IVIG. The results of investigate showed that the physical, chemical, and biological properties of all series meet the requirements of IVIG analytical documentation, the European and State Pharmacopoeias, but by the degree of purity was the most uniform drug series V (5% solution), while all the rest of the series (10% solutions of IVIG) contain contaminating proteins having a molecular weight of from 40 to about 140 kDa. In all the series of drug present IgA and IgM in an amount not exceeding the regulated value regulations. Furthermore, the definition immunohaematology safety showed the presence of a threat of hemolysis of erythrocytes in clinical application due to the high content of anti-D antibodies in VI series of IVIG. The findings suggest the need for careful observance of the technological process at all steps of the industrial manufacturing of IVIG and change the standard documentation regarding the survey donor plasma which is used for production of biopreparates.Branch of application - medicine, biotechnology. Product Description popup.authors Вергун Л.Ю. Загородня Ю.О. Любчак В.В. Сергутіна С.Ю. popup.nrat_date 2020-04-02 Close