<?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>S1025-028X2024000100005</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Capacidad de procesamiento de los nanofiltros empleados en la purificación de la proteína recombinante del dominio de unión al receptor del coronavirus tipo 2 del síndrome respiratorio agudo severo]]></article-title>
<article-title xml:lang="en"><![CDATA[Processability of nanofilters used in the purification of the recombinant receptor-binding domain protein of severe acute respiratory syndrome type 2 coronavirus]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Regalado-Fonseca]]></surname>
<given-names><![CDATA[Ivis]]></given-names>
</name>
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<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-de la Rosa]]></surname>
<given-names><![CDATA[Lourdes]]></given-names>
</name>
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</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castro-Figueroa]]></surname>
<given-names><![CDATA[Martha R.]]></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 M.]]></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=S1025-028X2024000100005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2024000100005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2024000100005&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN En el Centro de Inmunología Molecular se producen el ingrediente farmacéutico activo y la materia prima biológica empleados para la formulación de las vacunas SOBERANAS®. El antígeno de estas vacunas es la proteína del dominio de unión al receptor del coronavirus tipo 2 del síndrome respiratorio agudo severo. La producción de esta proteína recombinante se basa en el cultivo de células de ovario de hámster chino en biorreactores tipo tanque agitado. El proceso tecnológico a escala industrial consta de varias etapas: preparación de medios de cultivo y soluciones, fermentación, clarificación de sobrenadante y purificación. En los procesos biotecnológicos derivados de líneas celulares de origen animal, la contaminación viral endógena o adventicia constituye un riesgo potencial. Por tal motivo, en el proceso de purificación se emplea un paso específico para la remoción viral mediante la nanofiltración. Los nanofiltros empleados son materiales desechables que influyen significativamente en el costo del proceso. Actualmente se desconoce la capacidad de procesamiento de los nanofiltros en el proceso de purificación en cuestión, siendo el objetivo de la presente investigación con vistas a reducir los costos de producción. Se determinó la capacidad de procesamiento de los filtros Virosart CPV, siendo de 239,74 g/m2 (71,67% de saturación) y 1.259 g/m2 (67,82% de saturación) para la especie dímero y la mezcla, respectivamente. Se determinó la disminución del costo de producción de la etapa de nanofiltración, que representa una disminución del 54,85% del costo de filtración de la especie dímero y un 25% de la mezcla.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT The active pharmaceutical ingredient and the biological raw material, used for the formulation of the SOBERANA® vaccines, are produced at the Molecular Immunology Center. The antigen of these vaccines is the receptor-binding domain protein of the severe acute respiratory syndrome type 2 coronavirus. The production of this recombinant protein is based on the culture of Chinese hamster ovary cells in stirred tank bioreactors. The technological process on an industrial scale consists of several stages: preparation of culture media and solutions, fermentation, clarification of supernatant and purification. In biotechnological processes derived from cell lines of animal origin, endogenous or adventitious viral contamination is a potential risk. For this reason, a specific step for viral removal by nanofiltration is used in the purification process. The nanofilters used are disposable materials that significantly influence the cost of the process. The processing capacity of the nanofilters in the purification process in question is currently unknown, being the objective of the present investigation with a view to reducing production costs. The processing capacity of the Virosart CPV filters was determined to be 239.74 g/m2 (71.67% saturation) and 1,259 g/m2 (67.82% saturation) for the dimer species and the mixture, respectively. The decrease in the production cost of the nanofiltration stage was determined, representing a 54.85% decrease in the filtration cost for the dimer species and a 25% decrease for the mixture.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[filtros]]></kwd>
<kwd lng="es"><![CDATA[filtración por membranas]]></kwd>
<kwd lng="es"><![CDATA[nanoporos]]></kwd>
<kwd lng="es"><![CDATA[vacunas]]></kwd>
<kwd lng="en"><![CDATA[filters]]></kwd>
<kwd lng="en"><![CDATA[membrane filtration]]></kwd>
<kwd lng="en"><![CDATA[nanopores]]></kwd>
<kwd lng="en"><![CDATA[vaccines]]></kwd>
</kwd-group>
</article-meta>
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