<?xml version="1.0" encoding="ISO-8859-1"?><article 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">
<front>
<journal-meta>
<journal-id>1025-028X</journal-id>
<journal-title><![CDATA[Vaccimonitor]]></journal-title>
<abbrev-journal-title><![CDATA[Vaccimonitor]]></abbrev-journal-title>
<issn>1025-028X</issn>
<publisher>
<publisher-name><![CDATA[Finlay Ediciones]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1025-028X2024000100003</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Establecimiento del esquema de purificación de los antígenos de SOBERANA®02, SOBERANA®Plus y SOBERANA 01]]></article-title>
<article-title xml:lang="en"><![CDATA[Establishment of the purification scheme for SOBERANA®02, SOBERANA®Plus and SOBERANA 01 antigens]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Oca-García]]></surname>
<given-names><![CDATA[Daidée Montes de]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lozada-Chang]]></surname>
<given-names><![CDATA[Sum Lai]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Boggiano-Ayo]]></surname>
<given-names><![CDATA[Tammy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Zumalacárregui-de Cárdenas]]></surname>
<given-names><![CDATA[Lourdes]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández-Saez]]></surname>
<given-names><![CDATA[Olga Lidia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gómez-Peña]]></surname>
<given-names><![CDATA[Tania]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez-Massón]]></surname>
<given-names><![CDATA[Beatriz]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Inmunología Molecular  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad Tecnológica de La Habana ¨José Antonio Echeverría¨  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2024</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2024</year>
</pub-date>
<volume>33</volume>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2024000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2024000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2024000100003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN La urgente necesidad de desarrollar y producir vacunas seguras y efectivas para garantizar la reducción de la propagación del coronavirus de tipo 2 causante del síndrome respiratorio agudo severo, hizo que el Centro de Inmunología Molecular y el Instituto Finlay de Vacunas, desarrollaran dos vacunas y un candidato vacunal contra la COVID-19, que tienen como componente la molécula del dominio de unión al receptor (aa 319-541) del virus. Para establecer el proceso productivo, se realizaron experimentos en los posibles pasos del proceso de purificación de la molécula del dominio de unión al receptor (aa 319-541), con vistas a su posterior transferencia tecnológica a escala industrial. Dicha molécula está fusionada con una etiqueta de hexahistidina en su extremo C-terminal y presenta nueve residuos de cisteína en su secuencia que forman cuatro enlaces disulfuros intramoleculares, quedando una cisteína libre que permite obtener dos moléculas: dimérica y monomérica, antígenos que forman parte de las vacunas SOBERANA®02 y SOBERANA®Plus y el candidato vacunal SOBERANA 01. Se determinaron las mejores condiciones de adsorción de las matrices cromatográficas de afinidad por quelatos metálicos, intercambio catiónico y exclusión molecular. Se evaluó el desempeño del proceso a escala piloto y se caracterizó la molécula de acuerdo a sus propiedades físico-químicas y biológicas. Los resultados obtenidos mostraron un 60,02 ± 5,15% de recuperación total de la proteína de interés, con más del 98% de pureza en ambas moléculas, una eficiente remoción de contaminantes y una antigenicidad mayor del 90% referido al monómero control del dominio de unión al receptor con 99% de pureza, lo que demuestra que el proceso establecido es eficiente en la obtención de un producto con la calidad requerida.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT The urgent need to develop and produce safe and effective vaccines to guarantee the reduction of the spread of the type 2 coronavirus that causes severe acute respiratory syndrome, led the Center for Molecular Immunology and the Finlay Vaccine Institute to develop two vaccines and one candidate vaccine to combat the 2019 coronavirus pandemic. As part of the establishment of the production process, experiments were carried out on the possible steps of the purification process of the receptor binding domain molecule (aa 319-541) with a view to its subsequent technological transfer on an industrial scale. This molecule is fused with a hexahistidine tag at its C-terminal end and has nine cysteine residues in its sequence that form four intramolecular disulfide bonds; leaving a free cysteine that allows two molecules to be obtained: dimeric and monomeric, which constitute the antigens of the SOBERANA®02 and SOBERANA®Plus vaccines and the SOBERANA 01 vaccine candidate. The best adsorption conditions of the chromatographic matrices of affinity for metal chelates, cationic exchange and molecular exclusion were determined. The performance of the process was evaluated on a pilot scale and the molecule was characterized according to its physical-chemical and biological properties. The results obtained showed a 60.02 ± 5.15% total recovery of the protein of interest with more than 98% purity in both molecules, an efficient removal of contaminants and an antigenicity greater than 90% referred to the control monomer of the domain receptor binding with 99% purity; which demonstrates that the established process is efficient in obtaining a product with the required quality.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[COVID-19]]></kwd>
<kwd lng="es"><![CDATA[vacunas]]></kwd>
<kwd lng="es"><![CDATA[adsorción]]></kwd>
<kwd lng="en"><![CDATA[COVID-19]]></kwd>
<kwd lng="en"><![CDATA[vaccines]]></kwd>
<kwd lng="en"><![CDATA[adsorption]]></kwd>
</kwd-group>
</article-meta>
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