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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">biob</journal-id><journal-title-group><journal-title xml:lang="ru">Биобезопасность и Биотехнология</journal-title><trans-title-group xml:lang="en"><trans-title>Biosafety and Biotechnology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2707-7241</issn><issn pub-type="epub">2957-5702</issn><publisher><publisher-name>Научно-исследовательский институт проблем биологической безопасности</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.58318/2957-5702-2025-21-15-23</article-id><article-id custom-type="elpub" pub-id-type="custom">biob-151</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Articles</subject></subj-group></article-categories><title-group><article-title>КОНТРОЛЬ НЕКОТОРЫХ ПАРАМЕТРОВ ВАКЦИНЫ ПРОТИВ СИБИРСКОЙ ЯЗВЫ ДЛЯ КРУПНЫХ И МЕЛКИХ ЖИВОТНЫХ</article-title><trans-title-group xml:lang="en"><trans-title>CONTROL OF SOME PARAMETERS OF THE ANTHRAX VACCINE FOR CATTLE AND SMALL RUMINANT</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2049-686X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Оразымбетова</surname><given-names>Н. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Orazymbetova</surname><given-names>N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>пгт Гвардейский </p></bio><bio xml:lang="en"><p>Gvardeysky </p></bio><email xlink:type="simple">n.orazymbetova@biosafety.kz</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-1586-6736</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сейсенбаева</surname><given-names>М. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Seisenbaeva</surname><given-names>M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>пгт Гвардейский </p></bio><bio xml:lang="en"><p>Gvardeysky </p></bio><email xlink:type="simple">m.seisenbayeva@biosafety.kz</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0007-0183-4401</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Жақыпбек</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Zhakypbek</surname><given-names>A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>пгт Гвардейский </p></bio><bio xml:lang="en"><p>Gvardeysky </p></bio><email xlink:type="simple">a.zhakypbek@biosafety.kz</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2718-6506</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кошеметов</surname><given-names>Ж. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Koshemetov</surname><given-names>Zh.</given-names></name></name-alternatives><bio xml:lang="ru"><p>пгт Гвардейский </p></bio><bio xml:lang="en"><p>Gvardeysky </p></bio><email xlink:type="simple">zh.koshemetov@biosafety.kz</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3274-3004</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Умуралиев</surname><given-names>Б. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Umuraliyev</surname><given-names>B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>пгт Гвардейский </p></bio><bio xml:lang="en"><p>Gvardeysky </p></bio><email xlink:type="simple">b.umuraliyev@biosafety.kz</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0008-0523-7708</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Исахан</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Isakhan</surname><given-names>A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>пгт Гвардейский </p></bio><bio xml:lang="en"><p>Gvardeysky </p></bio><email xlink:type="simple">a.isakhan@biosafety.kz</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">ТОО «Научно-исследовательский институт проблем биологической безопасности», Национальный холдинг «QazBioPharm»<country>Казахстан</country></aff><aff xml:lang="en">«Research Institute for Biological Safety Problems» LLP, JSC "National Holding «QazBioPharm»<country>Kazakhstan</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>02</day><month>04</month><year>2025</year></pub-date><volume>0</volume><issue>21</issue><fpage>15</fpage><lpage>23</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Оразымбетова Н.Н., Сейсенбаева М.С., Жақыпбек А.С., Кошеметов Ж.К., Умуралиев Б.К., Исахан А.А., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Оразымбетова Н.Н., Сейсенбаева М.С., Жақыпбек А.С., Кошеметов Ж.К., Умуралиев Б.К., Исахан А.А.</copyright-holder><copyright-holder xml:lang="en">Orazymbetova N., Seisenbaeva M., Zhakypbek A., Koshemetov Z., Umuraliyev B., Isakhan A.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://journal.biosafety.kz/jour/article/view/151">https://journal.biosafety.kz/jour/article/view/151</self-uri><abstract><p>Тестирование биопрепаратов на стерильность, безвредность и определение концентрации водородных ионов обязательно в фармацевтической промышленности и регламентировано фармакопеями. Препараты для парентерального введения и некоторые другие растворы маркируются как «стерильно» и должны проходить контроль при производстве. Контаминация препаратов микроорганизмами может вызвать воспалительные процессы и сепсис у животных, поэтому производитель обязан обеспечивать чистоту и безвредность препаратов посредством производственного контроля. В статье представлены результаты испытаний биопрепарата «Вакцина жидкая живая против сибирской язвы из штамма «55-ВНИИВВИМ» для крупных и мелких животных» на контаминацию посторонней микрофлорой, безвредность и концентрацию водородных ионов. Испытания проводились согласно требованиям ГОСТ. Полученные данные подтвердили отсутствие роста посторонней бактериальной и грибной микрофлоры на питательных средах (мясопептонный бульон, мясо-пептонный агар, Сабуро и Китта-Тароцци), безвредность вакцины при подкожном применении на кроликах и соответствие показателя pH в большинстве серий нормативам. Исключение составила одна серия, где выявлено отклонение показателя pH на 0,2 единицы.</p></abstract><trans-abstract xml:lang="en"><p>Testing of biological products for sterility, harmlessness and determination of the concentration of hydrogen ions is mandatory in the pharmaceutical industry and is regulated by pharmacopoeias. Pharmaceuticals intended for intravenous, subcutaneous and intramuscular administration, as well as some other solutions, are available marked "sterile", therefore they must be checked at production. The ingress of microflora into sterile preparations can cause an inflammatory process or a septic condition, therefore the manufacturer is fully responsible for the sterility and harmlessness of solutions and carries out constant monitoring in production conditions. This article presents the results of tests conducted to verify sterility, harmlessness and determination of the concentration of hydrogen ions of series of the biological product "Liquid live vaccine against anthrax from the strain " 55-VNIIVVIM " for cattle and small ruminant." The vaccine was monitored in strict accordance with the approved regulatory documentation. When checking the vaccine, the following data were obtained: no growth of extraneous bacterial and fungal microflora was observed on nutrient media such as meat-peptone broth, meat-peptone agar, Saburo and KittaTarozzi media. Based on the analysis of the results obtained, it was established that the live anthrax vaccine from strain “55-VNIIVVIM” is sterile. At subcutaneous application of the vaccine, the tested preparation within 10 days after administration had no toxic effect on the body of rabbits, did not cause visible local and general manifestations, which proves the harmlessness of the preparation. The vaccine series showed non-significant pH differences of 0.1-0.3.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>сибирская язва</kwd><kwd>вакцина</kwd><kwd>контаминация посторонней микрофлорой</kwd><kwd>безвредность</kwd><kwd>биопрепарат</kwd><kwd>микробиология</kwd><kwd>испытание</kwd></kwd-group><kwd-group xml:lang="en"><kwd>anthrax</kwd><kwd>vaccine</kwd><kwd>sterility</kwd><kwd>harmlessness</kwd><kwd>biopreparation</kwd><kwd>microbiology</kwd><kwd>testing</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Rajesh K. Gupta, PhD. Role of Environmental Monitoring and Microbiological Testing During Manufacture of Sterile Drugs and Biologics. Biologics Quality &amp; Regulatory Consultants, LLC // American Pharmaceutical Review. - 2014. - Vol. 17, № 6. P. 46-55.</mixed-citation><mixed-citation xml:lang="en">Rajesh K. Gupta, PhD. 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