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Title: DEVELOPMENT OF PRODUCTION TECHNOLOGY OF PRE-PREPARED IMMUNOGLOBULIN AND ALBUMIN BIOLOGICS AT THE PLACE OF NON-STERILE BLOOD HARVESTING AND SEPARATING IN PRODUCTION PREMISES UNDER THE CONDITIONS WITHOUT REQUIRED CLEANLINESS
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DEVELOPMENT OF PRODUCTION TECHNOLOGY OF PRE-PREPARED IMMUNOGLOBULIN AND ALBUMIN BIOLOGICS AT THE PLACE OF NON-STERILE BLOOD HARVESTING AND SEPARATING IN PRODUCTION PREMISES UNDER THE CONDITIONS WITHOUT REQUIRED CLEANLINESS
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1314-2704
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English
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19
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6.1
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The main factor destroying the biosphere of the Planet is the increasing amount of industrial waste. Herewith, production bio-waste from health care and animal husbandry categorical objects plays a special role in generating infectious agents with unpredictable pathogenic potential. The most reliable way to disinfect them is the technology of elementary heat recovery. At the same time, in the 21st century this approach to clean up the territories from biocontaminants seems unacceptable for biosphere. Taking into account the fundamental problems of recombinant protein folding, we suppose to study the possibility of using of abortion and placental blood, human placental mass, slaughterhouse blood and animal endocrine raw materials within the goals and the objectives of viable development of the pharmaceutical bioindustry. However, at the present stage of technical and technological advances it seems impossible to organize harvesting of abortion or placental human blood, slaughterhouse or cadaveric animal blood on an industrial scale in accordance with the requirements of international standards for donated blood for production of pharmaceutical plasma biologics.
In particular, the projected technological innovations are focused on eliminating the pyrogenicity of finished biologics, ensuring their viral safety and preserving the conformational nativeness of target proteins. To create a scientific and technical groundwork, blood harvesting, cellular components separating and plasma samples incubating in the process of blood separation were carried out in the customized premises of specialized health institutions or livestock enterprises. While blood separation, serum plasma samples were incubated in saturated solutions of neutral salts containing bactericidal concentrations of identified and experimental disinfectants. The volume of plasma (serum) reaction loading ensured diluting of initial bactericidal fractionation solutions up to the concentrations ensuring the hydrophobic proteins precipitation. Hydrophilic proteins were precipitated from the supernatant centrifugate and the protein-free centrifugate was used to suspend the precipitation of hydrophobic and hydrophilic proteins. Suspensions of target proteins containing disinfectants (hereinafter, pre-prepared immunoglobulin and albumin biologics) were stored at (20 ± 5) ° ? for 180 days. Specific IgG and albumin in electrophoretic homogeneous and chromatographic monomeric form were isolated from the composition of semi-finished products under laboratory conditions. Purified samples were subjected to sterilizing filtration and stored for 12 months at the temperature of (5 ± 3) ° C. We believe that the obtained results form scientific and technical fundamental principles focused on the further development of the technology for pharmaceutical biologics production through the use of raw materials which were unclaimed by the bio-industryand were harvested in the form of pre-prepared biologics. |
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conference
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19th International Multidisciplinary Scientific GeoConference SGEM 2019
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19th International Multidisciplinary Scientific GeoConference SGEM 2019, 30 June - 6 July, 2019
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Proceedings Paper
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STEF92 Technology
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International Multidisciplinary Scientific GeoConference-SGEM
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Bulgarian Acad Sci; Acad Sci Czech Republ; Latvian Acad Sci; Polish Acad Sci; Russian Acad Sci; Serbian Acad Sci & Arts; Slovak Acad Sci; Natl Acad Sci Ukraine; Natl Acad Sci Armenia; Sci Council Japan; World Acad Sci; European Acad Sci, Arts & Letters; Ac
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667-674
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30 June - 6 July, 2019
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website
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cdrom
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6436
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pre-prepared blood plasma (serum); quality indicators
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