{"id":833,"date":"2021-05-18T10:48:51","date_gmt":"2021-05-18T10:48:51","guid":{"rendered":"https:\/\/www.vivebiotech.com\/services\/cdmo\/"},"modified":"2026-02-06T13:33:55","modified_gmt":"2026-02-06T12:33:55","slug":"cdmo","status":"publish","type":"page","link":"https:\/\/www.vivebiotech.com\/en\/services\/cdmo\/","title":{"rendered":"CDMO Services"},"content":{"rendered":"<h1>CDMO Services<\/h1>\n<h2>We are a lentiviral vector GMP CDMO offering personalized solutions for ex-vivo and in-vivo administration based on a complete adaptation to customer requirements.<\/h2>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/Servicios-CDMO-horizontal-en.webp\" alt=\"VIVEbiotech services\"><br \/>\n<img decoding=\"async\" src=\"\/wp-content\/uploads\/2025\/02\/Servicios-CDMO-vertical-en.webp\" alt=\"VIVEbiotech services\"><\/p>\n<h2>VIVEbiotech offers a wide range of manufacturing-related services on the lentiviral vectors produced, such as:<\/h2>\n<hr>\n<div>Early-phase development adapted to the requirements of each vector:\n<\/div>\n<div>\n<ul>\n<li>Cloning activities: from design to cloning aimed at increasing productivity and conforming to regulatory requirements, among others.<\/li>\n<li>Various tailored optimization activities: from adaptations in producer cell lines, to adjustments in transfection, to different pseudotyping strategies, etc.<\/li>\n<li>R&amp;D manufacture in 2D format.<\/li>\n<\/ul>\n<\/div>\n<hr>\n<div>R&amp;D manufacture in bioreactors.<\/div>\n<hr>\n<div>Manufacture of engineering batches for preclinical phases.<\/div>\n<hr>\n<div>GMP batches for clinical and commercial phases.<\/div>\n<hr>\n<div>Batch release by our own Qualified Person.<\/div>\n<hr>\n<div>Stability studies: long-term and in-use.<\/div>\n<hr>\n<div>Regulatory support including:<\/div>\n<div>\n<ul>\n<li>Chemistry, Manufacturing and Control (CMC) section of the Investigational Medicinal Product Dossier (IMPD).<\/li>\n<li>Chemistry, Manufacturing and Control (CMC) section of Investigational New Drug (IND).<\/li>\n<\/ul>\n<\/div>\n<hr>\n<div>Comprehensive management of outsourced partners (analytical testing and plasmid manufacturing, among others).<\/div>\n<h3>Specialization<\/h3>\n<h4>Exclusively working in lentivirus for ex-vivo and in-vivo administration.<\/h4>\n<ul>\n<li>\n<div>GMP CDMO business model.<\/div>\n<div>Covering the different phases.<\/div>\n<\/li>\n<li>\n<div>Meeting regulatory requirements.<\/div>\n<div>Compliance with EMA and FDA regulations.<\/div>\n<\/li>\n<li>\n<div>Expertise in virology. <\/div>\n<div>We make scalable, cost-effective and regulatory compliant lentiviral vectors.<\/div>\n<\/li>\n<li>\n<div>Customized approach to projets. <\/div>\n<div>Technical adaptation and slots availability in a timely manner.<\/div>\n<\/li>\n<li>\n<div>Ability to adapt to different stages of development.<\/div>\n<div>Scales available for every stage, from early development to commercial manufacturing.<\/div>\n<\/li>\n<li>\n<div>No own pipeline.<\/div>\n<div>Total priority to our customers&#8217; projects.<\/div>\n<\/li>\n<li>\n<div>International company.<\/div>\n<div>Projects in the U.S., Europe, Asia and Australia.<\/div>\n<\/li>\n<\/ul>\n<div>Certificates<\/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=\"https:\/\/www.vivebiotech.com\/wp-content\/uploads\/2026\/02\/Manufacturers-Authorisation_logo_03.png\" 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\":\"CDMO 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produced, such as:\",\"maxwidth\":\"2xlarge\",\"maxwidth_breakpoint\":\"m\",\"title_element\":\"h2\",\"title_style\":\"h3\"}},{\"type\":\"divider\",\"props\":{\"divider_element\":\"hr\",\"margin\":\"medium\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Early-phase development adapted to the requirements of each 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>Cloning activities: from design to cloning aimed at increasing productivity and conforming to regulatory requirements, among others.<\\\/li>\\n\n\n<li>Various tailored optimization activities: from adaptations in producer cell lines, to adjustments in transfection, to different pseudotyping strategies, etc.<\\\/li>\\n\n\n<li>R&amp;D manufacture in 2D 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