<?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>2221-2450</journal-id>
<journal-title><![CDATA[Revista CENIC Ciencias Biológicas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. CENIC Cienc. Biol]]></abbrev-journal-title>
<issn>2221-2450</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Investigaciones Científicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2221-24502023000100140</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[ALTERNATIVAS CROMATOGRÁFICAS PARA LA REMOCIÓN DE ENDOTOXINAS RESIDUALES EN EL PROCESO DE PURIFICACIÓN DE INMUNOGLOBULINAS HUMANAS]]></article-title>
<article-title xml:lang="en"><![CDATA[CHROMATOGRAPHIC ALTERNATIVES FOR THE REMOVAL OF RESIDUAL ENDOTOXINS IN THE PURIFICATION PROCESS OF HUMAN IMMUNOGLOBULINS]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Borrero Larger]]></surname>
<given-names><![CDATA[Héctor]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sánchez Gallardo]]></surname>
<given-names><![CDATA[Lorenzo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Biocubafarma Empresa Laboratorios AICA ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<volume>54</volume>
<fpage>140</fpage>
<lpage>157</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2221-24502023000100140&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2221-24502023000100140&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2221-24502023000100140&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN Se evaluaron, dos alternativas cromatográficas de intercambio iónico en modo negativo, a escala de laboratorio, para la remoción de endotoxinas en soluciones de inmunoglobulina. Se analizó la influencia de tres parámetros tecnológicos (concentración de proteínas, fuerza iónica y pH) en el comportamiento de los dos principales criterios técnicos de eficiencia del procedimiento: 1. Capacidad de remoción en endotoxinas expresada como EU (unidades de endotoxinas) totales, 2. Recobrado de proteínas expresado como mg/proteína total. El objetivo principal del trabajo fue seleccionar variantes que cumplan el requisito regulatorio para las inmunoglobulinas intravenosas, que tiene que ser &lt; 1 UE/mL. Se evaluó en la resina cromatográfica Fractogel-TMAE la incidencia de la concentración de proteínas y la fuerza iónica frente a una carga de endotoxinas conocida en el comportamiento de ambos criterios técnicos de eficiencia. La variante con una concentración de proteína cercana al 8%, sin refuerzo de fuerza iónica resultó la mejor opción. Como segunda alternativa para una carga de endotoxinas más baja, se evaluó para una membrana cromatográfica del tipo Sartobind-Q la incidencia del pH en el comportamiento de ambos criterios técnicos de eficiencia, manteniendo la concentración de proteínas alrededor de ~8%. En este caso la variante a pH=6,5 resultó la mejor opción integral. Para soluciones de inmunoglobulinas con concentración de proteína &#8804; 8,0 %, ambas alternativas son eficaces hasta 4 volúmenes de columna, en cuanto a capacidad de remoción de endotoxinas y recobrado superior al 85 %, pues cumplen la exigencia regulatoria para las inmunoglobulinas intravenosas.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Two ion exchange chromatographic alternatives in negative mode were evaluated, on a laboratory scale, for the removal of endotoxins in immunoglobulin solutions. Was analyzed the influence of three technological parameters (protein concentration, ionic strength and pH) on the behavior of the two main technical efficiency criteria of the procedure: 1. Endotoxin removal capacity expressed as total EU (endotoxin units), 2. Protein recovery expressed as mg/total protein. The main goal of the work was to select variants that meet the regulatory requirement for intravenous immunoglobulins, which has to be &lt; 1 EU/mL. The incidence of protein concentration and ionic strength against a known endotoxin load on the behavior of both technical efficiency criteria was evaluated for the chromatographic resin Fractogel-TMAE. The variant with a protein concentration close to 8%, without ionic strength reinforcement, was the best option. As a second alternative for a lower endotoxin load, was evaluated for a chromatographic membrane of the Sartobind-Q type, the incidence of pH on the behavior of both technical efficiency criteria, maintaining the protein concentration around ~8%. In this case the variant at pH=6.5 was the best integral option. For immunoglobulin solutions with protein concentration &#8804; 8.0 %, both alternatives are effective up to 4 column volume, in terms of endotoxin removal capacity and recovery greater than 85 %, since both meet the regulatory requirement for intravenous immunoglobulins.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[inmunoglobulina]]></kwd>
<kwd lng="es"><![CDATA[endotoxinas]]></kwd>
<kwd lng="es"><![CDATA[cromatografía]]></kwd>
<kwd lng="es"><![CDATA[recobrado de proteínas]]></kwd>
<kwd lng="en"><![CDATA[immunoglobulin]]></kwd>
<kwd lng="en"><![CDATA[endotoxins]]></kwd>
<kwd lng="en"><![CDATA[chromatography]]></kwd>
<kwd lng="en"><![CDATA[proteins recovery]]></kwd>
</kwd-group>
</article-meta>
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