{"id":6701,"date":"2026-09-16T06:54:15","date_gmt":"2026-09-16T04:54:15","guid":{"rendered":"https:\/\/amsbiopharma.com\/bioanalisis-de-acidos-nucleicos-y-terapia-genica-no-glp\/"},"modified":"2026-09-16T06:58:48","modified_gmt":"2026-09-16T04:58:48","slug":"bioanalisis-de-acidos-nucleicos-y-terapia-genica-no-glp","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/bioanalisis-de-acidos-nucleicos-y-terapia-genica-no-glp\/","title":{"rendered":"Bioan\u00e1lisis de \u00c1cidos Nucleicos y Terapia G\u00e9nica\/ NO-GLP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6701\" class=\"elementor elementor-6701 elementor-6697\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3bbb1079 e-flex e-con-boxed e-con e-parent\" data-id=\"3bbb1079\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-386401ae e-con-full e-flex e-con e-child\" data-id=\"386401ae\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-36ca91e6 e-con-full e-flex e-con e-child\" data-id=\"36ca91e6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6e1188b5 elementor-widget elementor-widget-heading\" data-id=\"6e1188b5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Bioan\u00e1lisis de \u00c1cidos Nucleicos y Terapia G\u00e9nica\/ NO-GLP<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-601091d2 e-con-full e-flex e-con e-child\" data-id=\"601091d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e1177f9 elementor-widget elementor-widget-text-editor\" data-id=\"7e1177f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Servicios especializados de bioan\u00e1lisis y caracterizaci\u00f3n para terap\u00e9uticos de \u00e1cidos nucleicos y programas de terapia g\u00e9nica.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1d3601d0 e-con-full e-flex e-con e-child\" data-id=\"1d3601d0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-3d35c303 e-con-full e-flex e-con e-child\" data-id=\"3d35c303\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;,&quot;background_video_link&quot;:&quot;https:\\\/\\\/amsbiopharma.com\\\/wp-content\\\/uploads\\\/Clip4_AnalyticalSupport_SM.mp4&quot;,&quot;background_play_on_mobile&quot;:&quot;yes&quot;,&quot;background_video_start&quot;:0,&quot;background_video_end&quot;:9,&quot;background_play_once&quot;:&quot;yes&quot;}\">\n\t\t<div class=\"elementor-background-video-container\">\n\t\t\t\t\t\t\t<video class=\"elementor-background-video-hosted\" role=\"presentation\" autoplay muted playsinline><\/video>\n\t\t\t\t\t<\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3383a05 e-flex e-con-boxed e-con e-parent\" data-id=\"3383a05\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-1b6a2b5 e-con-full e-flex e-con e-child\" data-id=\"1b6a2b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9330bb2 elementor-widget elementor-widget-text-editor\" data-id=\"9330bb2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Los terap\u00e9uticos de <\/span><b>\u00e1cidos nucleicos<\/b><span style=\"font-weight: 400;\"> y los vectores de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\"> representan las clases de f\u00e1rmacos anal\u00edticamente m\u00e1s exigentes del desarrollo farmac\u00e9utico contempor\u00e1neo. Desde los <\/span><b>oligonucle\u00f3tidos antisentido<\/b><span style=\"font-weight: 400;\"> y el <\/span><b>ARNi<\/b><span style=\"font-weight: 400;\"> hasta los terap\u00e9uticos de <\/span><b>ARNm<\/b><span style=\"font-weight: 400;\">, vectores virales y ADN plasm\u00eddico, estas modalidades requieren plataformas bioanal\u00edticas altamente especializadas y un profundo conocimiento de los marcos regulatorios aplicables.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma ha desarrollado una cartera integral de servicios bioanal\u00edticos y de caracterizaci\u00f3n para terap\u00e9uticos de \u00e1cidos nucleicos, cubriendo desde los estudios PK\/TK precl\u00ednicos tempranos hasta la caracterizaci\u00f3n <\/span><b>CMC<\/b><span style=\"font-weight: 400;\"> y el soporte para presentaciones regulatorias.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Todo el trabajo bioanal\u00edtico se realiza bajo sistemas de calidad controlados, con el desarrollo y validaci\u00f3n de m\u00e9todos alineados con el <\/span><b>ICH M10<\/b><span style=\"font-weight: 400;\">,.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e324efa e-con-full e-flex e-con e-child\" data-id=\"e324efa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d627e9 elementor-widget elementor-widget-image\" data-id=\"2d627e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"901\" height=\"365\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/as.png\" class=\"attachment-large size-large wp-image-3645\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/as.png 901w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/as-300x122.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/as-768x311.png 768w\" sizes=\"(max-width: 901px) 100vw, 901px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3bfdc4e6 e-con-full e-flex e-con e-parent\" data-id=\"3bfdc4e6\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-54ffdca6 e-con-full title-container e-flex e-con e-child\" data-id=\"54ffdca6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2531214f elementor-widget elementor-widget-heading\" data-id=\"2531214f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Descubre<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-30a0468 elementor-widget elementor-widget-html\" data-id=\"30a0468\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8zm144 276c0 6.6-5.4 12-12 12h-92v92c0 6.6-5.4 12-12 12h-56c-6.6 0-12-5.4-12-12v-92h-92c-6.6 0-12-5.4-12-12v-56c0-6.6 5.4-12 12-12h92v-92c0-6.6 5.4-12 12-12h56c6.6 0 12 5.4 12 12v92h92c6.6 0 12 5.4 12 12v56z\"><\/path><\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab00d17 elementor-nav-menu--dropdown-none discover-menu elementor-widget elementor-widget-nav-menu\" 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href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\" tabindex=\"-1\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\" tabindex=\"-1\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\" tabindex=\"-1\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a 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class=\"elementor-heading-title elementor-size-default\">Nuestro cat\u00e1logo de servicios incluye<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6b6ddfa e-con-full e-grid e-con e-child\" data-id=\"6b6ddfa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a20dad8 elementor-widget elementor-widget-image\" data-id=\"a20dad8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2156\" height=\"1641\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp\" class=\"attachment-full size-full wp-image-6147\" alt=\"Aplicaciones de Metabol\u00f3mica\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp 2156w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-300x228.webp 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1024x779.webp 1024w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-768x585.webp 768w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1536x1169.webp 1536w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-2048x1559.webp 2048w\" sizes=\"(max-width: 2156px) 100vw, 2156px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89947aa elementor-widget elementor-widget-n-accordion\" data-id=\"89947aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1440\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-1440\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis PK\/PD de Oligonucle\u00f3tidos, Transgenes y ADN\/ARN Viral <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1440\" class=\"elementor-element elementor-element-2001dcf e-con-full e-flex e-con e-child\" data-id=\"2001dcf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1440\" class=\"elementor-element elementor-element-02796f8 e-flex e-con-boxed e-con e-child\" data-id=\"02796f8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-623a24c elementor-widget elementor-widget-text-editor\" data-id=\"623a24c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El <\/span><b>bioan\u00e1lisis<\/b><span style=\"font-weight: 400;\"> de <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\"> y vectores de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\"> en matrices biol\u00f3gicas exige enfoques de complejidad y sensibilidad significativamente superiores a los aplicados a los f\u00e1rmacos convencionales de mol\u00e9cula peque\u00f1a. La similitud estructural entre la <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> y las especies end\u00f3genas de \u00e1cidos nucleicos impone exigencias excepcionales sobre la sensibilidad, especificidad y selectividad del m\u00e9todo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios <\/span><b>bioanal\u00edticos<\/b><span style=\"font-weight: 400;\"> PK\/PD validados para <\/span><b>oligonucle\u00f3tidos.<\/b><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Bioan\u00e1lisis<\/b><span style=\"font-weight: 400;\"> validado de <\/span><b>ASOs<\/b><span style=\"font-weight: 400;\">, <\/span><b>ARNi<\/b><span style=\"font-weight: 400;\">, <\/span><b>ARNm<\/b><span style=\"font-weight: 400;\"> y ADN\/ARN viral en matrices biol\u00f3gicas<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Capacidades en plasma, suero, tejido y <\/span><b>LCR<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desarrollo y validaci\u00f3n de m\u00e9todos conforme al <\/span><b>ICH M10<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte anal\u00edtico para estudios de distribuci\u00f3n tisular y biodistribuci\u00f3n<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1441\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1441\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Bioan\u00e1lisis de \u00c1cidos Nucleicos y Expresi\u00f3n G\u00e9nica <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1441\" class=\"elementor-element elementor-element-abb08fc e-con-full e-flex e-con e-child\" data-id=\"abb08fc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1441\" class=\"elementor-element elementor-element-10281b4 e-flex e-con-boxed e-con e-child\" data-id=\"10281b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9c3261a elementor-widget elementor-widget-text-editor\" data-id=\"9c3261a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">La cuantificaci\u00f3n fiable de especies de <\/span><b>\u00e1cidos nucleicos<\/b><span style=\"font-weight: 400;\"> y la evaluaci\u00f3n de cambios en la <\/span><b>expresi\u00f3n g\u00e9nica<\/b><span style=\"font-weight: 400;\"> en matrices biol\u00f3gicas son requisitos anal\u00edticos cr\u00edticos en el desarrollo de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\"> y terap\u00e9uticos de ARN.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma ofrece servicios <\/span><b>bioanal\u00edticos<\/b><span style=\"font-weight: 400;\"> validados para la cuantificaci\u00f3n de especies de ADN y ARN en matrices biol\u00f3gicas<\/span><span style=\"font-weight: 400;\">, incluyendo la evaluaci\u00f3n de cambios en la <\/span><b>expresi\u00f3n g\u00e9nica<\/b><span style=\"font-weight: 400;\"> relevantes para la monitorizaci\u00f3n farmacodin\u00e1mica y la evaluaci\u00f3n de seguridad. <\/span><span style=\"font-weight: 400;\">El desarrollo y validaci\u00f3n de m\u00e9todos se realizan conforme a las directrices regulatorias aplicables.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cuantificaci\u00f3n de especies de ADN y ARN en plasma, tejido y otras matrices<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An\u00e1lisis de <\/span><b>expresi\u00f3n g\u00e9nica<\/b><span style=\"font-weight: 400;\"> para programas de <\/span><b>biomarcadores<\/b><span style=\"font-weight: 400;\"> farmacodin\u00e1micos<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desarrollo de M\u00e9todos conforme a las directrices regulatorias aplicables<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para programas precl\u00ednicos<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable a terap\u00e9uticos de ARN y programas de vectores de <\/span><b>terapia g\u00e9nica<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documentaci\u00f3n completa para presentaciones regulatorias<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1442\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1442\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis de Biomarcadores Gen\u00e9ticos <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1442\" class=\"elementor-element elementor-element-1d4fd37 e-con-full e-flex e-con e-child\" data-id=\"1d4fd37\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1442\" class=\"elementor-element elementor-element-b99d9b7 e-flex e-con-boxed e-con e-child\" data-id=\"b99d9b7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee3fc23 elementor-widget elementor-widget-text-editor\" data-id=\"ee3fc23\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Los <\/span><b>biomarcadores gen\u00e9ticos<\/b><span style=\"font-weight: 400;\"> proporcionan informaci\u00f3n mecan\u00edstica y predictiva cada vez m\u00e1s central en el desarrollo moderno de f\u00e1rmacos, permitiendo la estratificaci\u00f3n de pacientes, la monitorizaci\u00f3n farmacodin\u00e1mica y los enfoques de medicina de precisi\u00f3n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma ofrece servicios anal\u00edticos validados para la detecci\u00f3n y cuantificaci\u00f3n de <\/span><b>biomarcadores gen\u00e9ticos<\/b><span style=\"font-weight: 400;\"> en muestras biol\u00f3gicas, con m\u00e9todos dise\u00f1ados para uso regulatorio en entornos precl\u00ednicos y cl\u00ednicos, y estrategias de <\/span><b>biomarcadores<\/b><span style=\"font-weight: 400;\"> alineadas con las gu\u00edas de calificaci\u00f3n regulatoria.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detecci\u00f3n y cuantificaci\u00f3n de <\/span><b>biomarcadores gen\u00e9ticos<\/b><span style=\"font-weight: 400;\"> en muestras biol\u00f3gicas<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Estrategias de <\/span><b>biomarcadores<\/b><span style=\"font-weight: 400;\"> alineadas con las expectativas regulatorias<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en oncolog\u00eda, enfermedades raras y programas de <\/span><b>terapia g\u00e9nica<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desarrollo de m\u00e9todos para estudios precl\u00ednicos.<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1443\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1443\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis de Isoformas de Pl\u00e1smido de ADN \/ GMP <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1443\" class=\"elementor-element elementor-element-cd09193 e-con-full e-flex e-con e-child\" data-id=\"cd09193\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1443\" class=\"elementor-element elementor-element-26b4964 e-flex e-con-boxed e-con e-child\" data-id=\"26b4964\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f592ba9 elementor-widget elementor-widget-text-editor\" data-id=\"f592ba9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El <\/span><b>ADN plasm\u00eddico<\/b><span style=\"font-weight: 400;\"> es un componente cr\u00edtico de la <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> en la fabricaci\u00f3n de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\"> y vacunas de ADN. La calidad, integridad y distribuci\u00f3n de isoformas son <\/span><b>atributos de calidad cr\u00edticos<\/b><span style=\"font-weight: 400;\"> que deben caracterizarse y controlarse durante la fabricaci\u00f3n. Las autoridades reguladoras exigen datos completos de caracterizaci\u00f3n del pl\u00e1smido como parte del paquete <\/span><b>CMC<\/b><span style=\"font-weight: 400;\"> para productos de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios anal\u00edticos validados para la caracterizaci\u00f3n de isoformas de <\/span><b>pl\u00e1smido de ADN<\/b><span style=\"font-weight: 400;\">, permitiendo <\/span><span style=\"font-weight: 400;\">la cuantificaci\u00f3n <\/span><span style=\"font-weight: 400;\">y la distribuci\u00f3n relativa de isoformas superenrolladas, circulares abiertas y lineales en muestras de <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> y producto terminado.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cuantificaci\u00f3n y distribuci\u00f3n de isoformas de <\/span><b>pl\u00e1smido de ADN<\/b><span style=\"font-weight: 400;\"> (superenrollada, circular abierta, lineal)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> en proceso y de <\/span><b>sustancia activa<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u00e9todos de soporte para desarrollo <\/span><b>CMC<\/b><span style=\"font-weight: 400;\"> y optimizaci\u00f3n de procesos<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable a vectores de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\"> y programas de vacunas de ADN<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desarrollo de M\u00e9todos con sensibilidad y especificidad adecuadas<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<div class=\"entry-summary\">\nBioan\u00e1lisis de \u00c1cidos Nucleicos y Terapia G\u00e9nica\/ NO-GLP Servicios especializados de bioan\u00e1lisis y caracterizaci\u00f3n para terap\u00e9uticos de \u00e1cidos nucleicos y programas de terapia g\u00e9nica. Los terap\u00e9uticos de \u00e1cidos nucleicos y los vectores de terapia g\u00e9nica representan las clases de f\u00e1rmacos&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/bioanalisis-de-acidos-nucleicos-y-terapia-genica-no-glp\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Bioan\u00e1lisis de \u00c1cidos Nucleicos y Terapia G\u00e9nica\/ NO-GLP&rdquo;<\/span>&hellip;<\/a><\/div>\n","protected":false},"author":6,"featured_media":4763,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-6701","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6701","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/comments?post=6701"}],"version-history":[{"count":1,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6701\/revisions"}],"predecessor-version":[{"id":6702,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6701\/revisions\/6702"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media\/4763"}],"wp:attachment":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media?parent=6701"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}