{"id":19,"date":"2021-05-18T10:48:51","date_gmt":"2021-05-18T10:48:51","guid":{"rendered":"https:\/\/www.vivebiotech.com\/?page_id=19"},"modified":"2026-02-04T10:22:22","modified_gmt":"2026-02-04T09:22:22","slug":"cdmo","status":"publish","type":"page","link":"https:\/\/www.vivebiotech.com\/es\/servicios\/cdmo\/","title":{"rendered":"Servicios CDMO"},"content":{"rendered":"<h1>Servicios CDMO<\/h1>\n<h2>Somos una organizaci\u00f3n de desarrollo y fabricaci\u00f3n (CDMO) GMP de vectores lentivirales para su administraci\u00f3n tanto ex vivo como in vivo que ofrece soluciones personalizadas basadas en la revisi\u00f3n de los requerimientos de los\/as clientes\/as.<\/p>\n<\/h2>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/Servicios-CDMO-horizontal-es.webp\" alt=\"Servicios VIVEbiotech\"><br \/>\n<img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/Servicios-CDMO-vertical-es.webp\" alt=\"Servicios VIVEbiotech\"><\/p>\n<h2>VIVEbiotech ofrece una amplia gama de servicios relacionados con la fabricaci\u00f3n sobre los vectores lentivirales producidos, tales como:<\/h2>\n<hr>\n<div>Desarrollo en fases iniciales, con adaptaci\u00f3n a las necesidades de cada vector:\n<\/div>\n<div>\n<ul>\n<li>Actividades de clonaje: desde dise\u00f1o hasta clonajes con el fin de aumentar productividad, ajustarse a requerimientos regulatorios, entre otros.<\/li>\n<li>Actividades de optimizaci\u00f3n customizadas diversas: desde adaptaciones en la l\u00ednea celular productora, hasta ajustes en la transfecci\u00f3n, diferentes estrategias de pseudotipado\u2026<\/li>\n<li>Fabricaci\u00f3n en calidad I+D en formato 2D.<\/li>\n<\/ul>\n<\/div>\n<hr>\n<div>Fabricaci\u00f3n en calidad I+D en biorreactores.<\/div>\n<hr>\n<div>Fabricaci\u00f3n de lotes de ingenier\u00eda para fases precl\u00ednicas.<\/div>\n<hr>\n<div>Lotes GMP para fases cl\u00ednicas y comerciales.<\/div>\n<hr>\n<div>Liberaci\u00f3n de lotes por Direcci\u00f3n T\u00e9cnica propia.<\/div>\n<hr>\n<div>Estudios de estabilidad: largo plazo e in use.<\/div>\n<hr>\n<div>Soporte regulatorio incluyendo:<\/div>\n<div>\n<ul>\n<li>Secci\u00f3n de Qu\u00edmica, Fabricaci\u00f3n y Control (Chemistry, Manufacturing and Control, CMC) del Dossier de Medicamentos en Investigaci\u00f3n (Investigational Medicinal Product Dossier, IMPD).<\/li>\n<li>Secci\u00f3n de Qu\u00edmica, Fabricaci\u00f3n y Control (Chemistry, Manufacturing and Control, CMC) del Nuevos Medicamentos en Investigaci\u00f3n (Investigational New Drug, IND).<\/li>\n<\/ul>\n<\/div>\n<hr>\n<div>Gesti\u00f3n integral de partners subcontratados (ensayos anal\u00edticos y fabricaci\u00f3n de pl\u00e1smidos, entre otros).<\/div>\n<h3>Especializaci\u00f3n<\/h3>\n<h4>Trabajamos con lentivirus para su administraci\u00f3n tanto ex vivo como in vivo de manera exclusiva.<\/h4>\n<ul>\n<li>\n<div>Modelo de negocio CDMO GMP. <\/div>\n<div>Cobertura de las diferentes fases.<\/div>\n<\/li>\n<li>\n<div>Cumplimiento con los requisitos regulatorios.<\/div>\n<div>En cumplimiento con la normativa de la EMA y la FDA.<\/div>\n<\/li>\n<li>\n<div>Expertise en virolog\u00eda.<\/div>\n<div>Fabricamos vectores lentivirales escalables, coste-efectivos y conformes con la normativa vigente.<\/div>\n<\/li>\n<li>\n<div>Enfoque personalizado para cada proyecto. <\/div>\n<div>Adaptaci\u00f3n t\u00e9cnica y disponibilidad de slots de manera oportuna.<\/div>\n<\/li>\n<li>\n<div>Capacidad de adaptaci\u00f3n a las diferentes fases de desarrollo.<\/div>\n<div>Escalas disponibles adecuadas para cada fase: desde fases iniciales hasta comerciales.<\/div>\n<\/li>\n<li>\n<div>No pipeline propio.<\/div>\n<div> Prioridad total a los proyectos de nuestros\/as clientes\/as.<\/div>\n<\/li>\n<li>\n<div>Compa\u00f1\u00eda internacional.<\/div>\n<div>Proyectos en EEUU, Europa, Asia y Australia.<\/div>\n<\/li>\n<\/ul>\n<div>Certificados<\/div>\n<hr>\n<ul>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/european-commission.webp\" alt=\"European Commission Logo\"><\/p>\n<p><a href=\"https:\/\/www.vivebiotech.com\/wp-content\/uploads\/2021\/06\/Seal-of-Excellence-VIVEBIOTECH.pdf\"><\/a><\/p>\n<\/li>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/certificado-gmp.webp\" alt=\"Certificado GMP Logo\"><\/p>\n<p><a href=\"https:\/\/www.vivebiotech.com\/wp-content\/uploads\/2025\/10\/Certificado-de-Cumplimiento-NCF_ES067I25.pdf\"><\/a><\/p>\n<\/li>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/autorizacion-fabricante.webp\" alt=\"Autorizacion fabricante Logo\"><\/p>\n<p><a href=\"https:\/\/www.vivebiotech.com\/wp-content\/uploads\/2024\/11\/Documento-de-autorizacion-del-laboratorio.pdf\"><\/a><\/p>\n<\/li>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/cir-extend.webp\" alt=\"Cir extend Logo\"><\/p>\n<p><a href=\"\/wp-content\/uploads\/2024\/09\/VIVEBIOTECH-S.L-decision.pdf\"><\/a><\/p>\n<\/li>\n<\/ul>\n<p><!--more--><br \/>\n<!-- {\"type\":\"layout\",\"children\":[{\"type\":\"section\",\"props\":{\"animation\":\"slide-bottom-medium\",\"animation_delay\":\"200\",\"image_position\":\"center-center\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"headline\",\"props\":{\"content\":\"Servicios CDMO\",\"title_element\":\"h1\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Somos una organizaci\\u00f3n de desarrollo y fabricaci\\u00f3n (CDMO) GMP de vectores lentivirales para su administraci\\u00f3n tanto ex vivo como in vivo que ofrece soluciones personalizadas basadas en la revisi\\u00f3n de los 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como:\",\"maxwidth\":\"2xlarge\",\"maxwidth_breakpoint\":\"m\",\"title_element\":\"h2\",\"title_style\":\"h3\"}},{\"type\":\"divider\",\"props\":{\"divider_element\":\"hr\",\"margin\":\"medium\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Desarrollo en fases iniciales, con adaptaci\\u00f3n a las necesidades de cada vector:\\n\",\"maxwidth\":\"2xlarge\",\"maxwidth_breakpoint\":\"m\",\"title_element\":\"div\",\"title_style\":\"h3\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<ul>\\n\n\n<li>Actividades de clonaje: desde dise\\u00f1o hasta clonajes con el fin de aumentar productividad, ajustarse a requerimientos regulatorios, entre otros.<\\\/li>\\n\n\n<li>Actividades de optimizaci\\u00f3n customizadas diversas: desde adaptaciones en la l\\u00ednea celular productora, hasta ajustes en la transfecci\\u00f3n, diferentes estrategias de pseudotipado\\u2026<\\\/li>\\n\n\n<li>Fabricaci\\u00f3n en calidad I+D en formato 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