<?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>S1025-028X2021000200060</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Modelo matemático para predecir la formación de agregados en el proceso de purificación de un anticuerpo monoclonal]]></article-title>
<article-title xml:lang="en"><![CDATA[Mathematical model for predicting the formation of aggregates in the purification process of a monoclonal antibody]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Mora-Montes de Oca]]></surname>
<given-names><![CDATA[Osvaldo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</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[Regalado-Fonseca]]></surname>
<given-names><![CDATA[Ivis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-de la Rosa]]></surname>
<given-names><![CDATA[Lourdes]]></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 &#8220;José Antonio Echeverría&#8221;  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2021</year>
</pub-date>
<volume>30</volume>
<numero>2</numero>
<fpage>60</fpage>
<lpage>68</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2021000200060&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2021000200060&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2021000200060&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El uso de anticuerpos monoclonales en la lucha contra el cáncer se convierte cada día más en la terapia de elección. Para la introducción de anticuerpos monoclonales en mercados internacionales de alta demanda y con elevados requerimientos de calidad se requiere su producción a gran escala. El incremento de la presencia de dímeros en el producto final afecta su calidad y, por tanto, la eficiencia y eficacia del proceso. El objetivo del presente trabajo fue obtener un modelo matemático que permita relacionar el porcentaje de dímeros con las variables de operación de mayor influencia. Se realizó el ajuste de un modelo de regresión lineal múltiple usando el programa Statgraphics Centurion XVII versión 17.2.00. El modelo se validó con lotes de producción, logrando errores relativos inferiores al 20%. Las variables significativas obtenidas fueron: masa de IgG en el sobrenadante; masa de IgG en el producto de salida del paso de captura de proteína A; pH en el producto de salida del paso de captura de proteína A; pH del producto ajustado y conductividad de salida en la membrana de intercambio aniónico. El modelo permitió encontrar un intervalo de trabajo de las variables de mayor influencia en la formación de dímeros para reducirlos hasta valores inferiores al 3%.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT The use of monoclonal antibodies in the fight against cancer is becoming more and more the selected therapy. The introduction of monoclonal antibodies highly demanded in international markets, with high quality requirements needs the production of monoclonal antibodies on a large scale. The increase of dimers in the final product affects its quality, therefore, the efficiency and effectiveness of the process. The objective of this work was to obtain a mathematical model to relate the percentage of dimers with the most influential operating variables. A multiple linear regression model was obtained using Statgraphics Centurion XVII version 17.2.00 software. The model was validated with new production data with a mean error of validation below 20%. The significant variables were: supernatant IgG mass; IgG mass in the effluent from Protein A capture column; pH of the effluent from Protein A capture column; pH of the adjusted product and conductivity of the effluent from anionic exchange membrane. A working interval for each of the influential variables were established, in order to reduce dimers below 3%.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[anticuerpos monoclonales]]></kwd>
<kwd lng="es"><![CDATA[purificación]]></kwd>
<kwd lng="es"><![CDATA[análisis de datos]]></kwd>
<kwd lng="es"><![CDATA[modelo matemático]]></kwd>
<kwd lng="en"><![CDATA[monoclonal antibodies]]></kwd>
<kwd lng="en"><![CDATA[purification]]></kwd>
<kwd lng="en"><![CDATA[data analysis]]></kwd>
<kwd lng="en"><![CDATA[mathematical model]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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<source><![CDATA[J Chromatogr A]]></source>
<year>2015</year>
<volume>1415</volume>
<numero>10</numero>
<issue>10</issue>
<page-range>83-90</page-range></nlm-citation>
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</back>
</article>
