<?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>S1025-028X2020000100005</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Aplicación del Análisis de Componentes Principales en el proceso de purificación de un biofármaco]]></article-title>
<article-title xml:lang="en"><![CDATA[Application of Principal Component Analysis in the purification process of a biopharmaceutical]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gozá-León]]></surname>
<given-names><![CDATA[Osvaldo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández-Águila]]></surname>
<given-names><![CDATA[Marí]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-Garcel]]></surname>
<given-names><![CDATA[Rosa Haydee]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ojito-Magaz]]></surname>
<given-names><![CDATA[Eduardo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Tecnológica de La Habana &#8220;José Antonio Echeverría&#8221; Facultad de Ingeniería Química ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,UEB Destilería de la Ronera Santa Cruz del Norte  ]]></institution>
<addr-line><![CDATA[Mayabeque ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Centro de Inmunología Molecular  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2020</year>
</pub-date>
<volume>29</volume>
<numero>1</numero>
<fpage>5</fpage>
<lpage>13</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2020000100005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2020000100005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2020000100005&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN En este trabajo se presenta la aplicación del Análisis de Componentes Principales, mediante el programa THE UNSCRAMBLER versión 8.0, a los datos registrados en un período de 2 años en la etapa de purificación de una planta de producción de Eritropoyetina Humana Recombinante que está basada en varios pasos cromatográficos, de forma similar a los procesos de purificación de proteínas recombinantes que se utilizan como vacunas preventivas o terapéuticas. Se logró reducir dimensionalidad al obtenerse dos componentes principales que explican el 81% de la varianza de 18 variables originales relacionadas con cuatro pasos cromatográficos. Como resultado se llegó a definir cuáles son las variables que mayor aporte tienen a la variabilidad del proceso en la etapa de purificación, permitiendo extraer información útil para lograr un mayor entendimiento del proceso y enriquecer las estrategias de control en la planta. Dichos resultados corroboraron experiencias prácticas de especialistas de la planta y permitieron dar recomendaciones a considerar en el plan de verificación continuada del proceso como proponer cinco variables como controles de proceso y tener en cuenta que el rendimiento del segundo paso cromatográfico es el más influyente de los rendimientos considerados en la variabilidad.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT This paper presents the application of the Principal Component Analysis, using the program THE UNSCRAMBLER version 8.0, to the data recorded during two years in the purification stage of a Recombinant Human Erythropoietin plant that is based on several chromatographic steps, similar to the purification process of recombinant proteins that are used as preventive or therapeutic vaccines. Dimensionality was reduced by obtaining two main components that explain 81% of the variance of 18 original variables related to four chromatographic steps. As a result, it was possible to define which variables have the greatest contribution to the variability of the process in the purification stage, allowing to extract useful information to achieve a greater understanding of the process and enrich the control strategies in the plant. These results corroborated practical experiences of plant specialists and allowed for recommendations to be considered in the continuous verification plan of the process, such as proposing three variables as process controls and taking into account that the performance of the second step is the most influential of the performances considered in the variability.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[productos biológicos]]></kwd>
<kwd lng="es"><![CDATA[cromatografía]]></kwd>
<kwd lng="es"><![CDATA[Análisis de Componentes Principales]]></kwd>
<kwd lng="en"><![CDATA[biological products]]></kwd>
<kwd lng="en"><![CDATA[chromatography]]></kwd>
<kwd lng="en"><![CDATA[Principal Component Analysis]]></kwd>
</kwd-group>
</article-meta>
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<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Gálvez-Torriente]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Aplicación del Análisis de Componentes Principales en el proceso de fermentación de un anticuerpo monoclonal]]></article-title>
<source><![CDATA[VacciMonitor]]></source>
<year>2018</year>
<volume>27</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>8-15</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
