{"id":3864,"date":"2024-10-01T17:16:13","date_gmt":"2024-10-01T15:16:13","guid":{"rendered":"https:\/\/amsbiopharma.com\/analysis-of-nucleic-acid-based-biopharmaceuticals\/"},"modified":"2026-09-23T15:11:16","modified_gmt":"2026-09-23T13:11:16","slug":"analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/","title":{"rendered":"Oligonucle\u00f3tidos\/ No GLP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3864\" class=\"elementor elementor-3864 elementor-521\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c938bb e-flex e-con-boxed e-con e-parent\" data-id=\"7c938bb\" 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-8d8959d e-con-full e-flex e-con e-child\" data-id=\"8d8959d\" 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-d7eb23a e-con-full e-flex e-con e-child\" data-id=\"d7eb23a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d892d2 elementor-widget elementor-widget-heading\" data-id=\"1d892d2\" 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\">Oligonucle\u00f3tidos<\/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-1996a70 e-con-full e-flex e-con e-child\" data-id=\"1996a70\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad4e31f elementor-widget elementor-widget-text-editor\" data-id=\"ad4e31f\" 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 caracterizaci\u00f3n anal\u00edtica y control de calidad para sustancias activas y productos de oligonucle\u00f3tidos terap\u00e9uticos.<\/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-16da3bc e-con-full e-flex e-con e-child\" data-id=\"16da3bc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;,&quot;background_video_end&quot;:7,&quot;background_play_once&quot;:&quot;yes&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-76cd4566 e-con-full e-flex e-con e-child\" data-id=\"76cd4566\" 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\\\/Clip1_Analysis_Nucleic_Aci_Based_Biopharmaceuticals_SM.mp4&quot;,&quot;background_play_on_mobile&quot;:&quot;yes&quot;,&quot;background_video_start&quot;:0,&quot;background_video_end&quot;:7,&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-4e511c3 e-flex e-con-boxed e-con e-parent\" data-id=\"4e511c3\" 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-d496bc6 e-con-full e-flex e-con e-child\" data-id=\"d496bc6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b710c63 elementor-widget elementor-widget-heading\" data-id=\"b710c63\" 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\">Oligonucle\u00f3tidos terap\u00e9uticos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4f9f94 elementor-widget elementor-widget-text-editor\" data-id=\"f4f9f94\" 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>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\"> \u2014<\/span><b>oligonucle\u00f3tidos antisentido<\/b><span style=\"font-weight: 400;\"> (<\/span><b>ASO<\/b><span style=\"font-weight: 400;\">), ARN de interferencia peque\u00f1o (<\/span><b>ARNi<\/b><span style=\"font-weight: 400;\">), mim\u00e9ticos e inhibidores de microARN, apt\u00e1meros, oligonucle\u00f3tidos que modulan el splicing y otras modalidades\u2014 representan uno de los segmentos m\u00e1s innovadores de la cartera farmac\u00e9utica. Estas complejas mol\u00e9culas sint\u00e9ticas presentan retos de <\/span><b>caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> anal\u00edtica que requieren experiencia dedicada, plataformas cromatogr\u00e1ficas especializadas y un conocimiento profundo del marco regulatorio.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La complejidad estructural de los <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\"> modernos \u2014que habitualmente incorporan m\u00faltiples modificaciones en el esqueleto y las bases para mejorar la <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\">, reducir la <\/span><b>inmunogenicidad<\/b><span style=\"font-weight: 400;\"> y mejorar las propiedades farmacocin\u00e9ticas\u2014 exige m\u00e9todos anal\u00edticos espec\u00edficamente dise\u00f1ados para caracterizar estas modificaciones y distinguir la <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> de las <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> estrechamente relacionadas. La resoluci\u00f3n cromatogr\u00e1fica de especies que difieren en tan solo un nucle\u00f3tido requiere plataformas <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\"> de \u00faltima generaci\u00f3n con cromatograf\u00eda de par i\u00f3nico.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona una suite integral de servicios de <\/span><b>caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> anal\u00edtica y <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> para <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\">, cubriendo la identidad, la pureza, la integridad de la secuencia\u2014los pilares anal\u00edticos fundamentales de cualquier presentaci\u00f3n regulatoria.<\/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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1b7238cc e-con-full e-flex e-con e-parent\" data-id=\"1b7238cc\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-247a6548 e-con-full title-container e-flex e-con e-child\" data-id=\"247a6548\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9d1ea12 elementor-widget elementor-widget-heading\" data-id=\"9d1ea12\" 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-1db51c05 elementor-widget elementor-widget-html\" data-id=\"1db51c05\" 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\" 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class=\"elementor-element elementor-element-51050db elementor-widget elementor-widget-image\" data-id=\"51050db\" 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=\"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-a2320e7 elementor-widget elementor-widget-n-accordion\" data-id=\"a2320e7\" 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-1700\" 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-1700\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Medida de Masa Exacta de Oligonucle\u00f3tidos (Non GMP) \/ NON GLP <\/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-1700\" class=\"elementor-element elementor-element-345d936 e-con-full e-flex e-con e-child\" data-id=\"345d936\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1700\" class=\"elementor-element elementor-element-d14721a e-flex e-con-boxed e-con e-child\" data-id=\"d14721a\" 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-6adaaf1 elementor-widget elementor-widget-text-editor\" data-id=\"6adaaf1\" 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 medida de masa exacta por espectrometr\u00eda de masas de alta resoluci\u00f3n proporciona la confirmaci\u00f3n de identidad m\u00e1s definitiva disponible para los <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\">, proporcionando una f\u00f3rmula molecular precisa que confirma el n\u00famero e identidad de los nucle\u00f3tidos constituyentes, las modificaciones del esqueleto y cualquier otra modificaci\u00f3n qu\u00edmica incorporada en la <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma ofrece servicios validados de medida de masa exacta para <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\"> usando <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\"> acoplado a espectrometr\u00eda de masas de alta resoluci\u00f3n con condiciones de cromatograf\u00eda de par i\u00f3nico. El software de deconvoluci\u00f3n del estado de carga proporciona masas medias y monoisot\u00f3picas deconvolucionadas.<\/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;\">Determinaci\u00f3n de masa exacta con precisi\u00f3n sub-ppm para <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cobertura de <\/span><b>ASOs<\/b><span style=\"font-weight: 400;\">, <\/span><b>ARNi<\/b><span style=\"font-weight: 400;\">, apt\u00e1meros y especies muy modificadas<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>UHPLC<\/b><span style=\"font-weight: 400;\">-EM de alta resoluci\u00f3n con cromatograf\u00eda de par i\u00f3nico<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Deconvoluci\u00f3n del estado de carga para la determinaci\u00f3n de masa del <\/span><b>oligonucle\u00f3tido<\/b><span style=\"font-weight: 400;\"> intacto<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en especies con fosforotioato, modificaciones 2&#8242; y otras modificaciones del esqueleto<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Datos de confirmaci\u00f3n de identidad para presentaciones regulatorias <\/span><b>CMC<\/b><\/li>\n<p><\/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-1701\" 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-1701\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Pureza e Identificaci\u00f3n de Impurezas de Oligonucle\u00f3tidos \/ NON GLP <\/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-1701\" class=\"elementor-element elementor-element-f7b8875 e-con-full e-flex e-con e-child\" data-id=\"f7b8875\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1701\" class=\"elementor-element elementor-element-4620c37 e-flex e-con-boxed e-con e-child\" data-id=\"4620c37\" 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-384f0c2 elementor-widget elementor-widget-text-editor\" data-id=\"384f0c2\" 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 evaluaci\u00f3n de la pureza es un ensayo cr\u00edtico de <\/span><b>liberaci\u00f3n de lotes<\/b><span style=\"font-weight: 400;\"> y monitorizaci\u00f3n de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> para los <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\">, garantizando que la <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> cumple su especificaci\u00f3n de pureza y que las <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> relacionadas con el proceso \u2014secuencias truncadas (n-1, n-2), secuencias con deleciones, secuencias extendidas (n+1) y otros subproductos sint\u00e9ticos\u2014 est\u00e1n dentro de los criterios de aceptaci\u00f3n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios anal\u00edticos validados basados en <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\"> para la determinaci\u00f3n de la pureza e identificaci\u00f3n de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\">, aplicando cromatograf\u00eda de fase inversa de par i\u00f3nico con detecci\u00f3n <\/span><b>UV<\/b><span style=\"font-weight: 400;\"> para cuantificaci\u00f3n y detecci\u00f3n espectrom\u00e9trica de masas para la identificaci\u00f3n de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\">.<\/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;\">Determinaci\u00f3n de pureza por <\/span><b>UHPLC-UV<\/b><span style=\"font-weight: 400;\"> validado con cromatograf\u00eda de par i\u00f3nico<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Resoluci\u00f3n cromatogr\u00e1fica de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> de secuencia n-1, n-2, n+1<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identificaci\u00f3n de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> por <\/span><b>LC-MS<\/b><span style=\"font-weight: 400;\"> para <\/span><b>caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> estructural<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en <\/span><b>ASOs<\/b><span style=\"font-weight: 400;\">, <\/span><b>ARNi<\/b><span style=\"font-weight: 400;\">, apt\u00e1meros y <\/span><b>oligonucle\u00f3tidos<\/b><span style=\"font-weight: 400;\"> modificados<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para desarrollo <\/span><b>CMC<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<p><\/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-1702\" 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-1702\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Confirmaci\u00f3n de Secuencia de Oligonucle\u00f3tidos \/ NON GLP <\/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-1702\" class=\"elementor-element elementor-element-8128fc8 e-con-full e-flex e-con e-child\" data-id=\"8128fc8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1702\" class=\"elementor-element elementor-element-f60b0c7 e-flex e-con-boxed e-con e-child\" data-id=\"f60b0c7\" 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-36e02fb elementor-widget elementor-widget-text-editor\" data-id=\"36e02fb\" 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 confirmaci\u00f3n de secuencia proporciona la verificaci\u00f3n de identidad definitiva para los <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\">, garantizando que la <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> tiene la secuencia nucleot\u00eddica prevista y que todas las modificaciones qu\u00edmicas est\u00e1n presentes en las posiciones correctas. Es un componente obligatorio del paquete de <\/span><b>caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> de identidad para presentaciones regulatorias.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios validados de confirmaci\u00f3n de secuencia usando enfoques basados en espectrometr\u00eda de masas en t\u00e1ndem (<\/span><b>MS\/MS<\/b><span style=\"font-weight: 400;\">), generando series de iones fragmento que confirman la secuencia nucleot\u00eddica y localizan las modificaciones qu\u00edmicas a lo largo de toda la longitud del <\/span><b>oligonucle\u00f3tido<\/b><span style=\"font-weight: 400;\">.<\/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;\">Confirmaci\u00f3n de secuencia basada en <\/span><b>MS\/MS<\/b><span style=\"font-weight: 400;\"> con cobertura integral de iones de secuencia<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identificaci\u00f3n y localizaci\u00f3n de modificaciones del esqueleto y de las bases<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Confirmaci\u00f3n de enlaces fosforotioato, modificaciones 2&#8242; y otras caracter\u00edsticas del esqueleto<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Datos de identidad de secuencia de calidad regulatoria para presentaciones <\/span><b>CMC<\/b><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para <\/span><b>oligonucle\u00f3tidos<\/b><span style=\"font-weight: 400;\"> cortos y largos<\/span><\/li>\n<p><\/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-1703\" 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-1703\" >\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 Estabilidad y Degradaci\u00f3n de Oligonucle\u00f3tidos \/ NON GLP <\/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-1703\" class=\"elementor-element elementor-element-2fa6adf e-con-full e-flex e-con e-child\" data-id=\"2fa6adf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1703\" class=\"elementor-element elementor-element-bbe6db8 e-flex e-con-boxed e-con e-child\" data-id=\"bbe6db8\" 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-1930f30 elementor-widget elementor-widget-text-editor\" data-id=\"1930f30\" 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 an\u00e1lisis de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> y degradaci\u00f3n para <\/span><b>oligonucle\u00f3tidos terap\u00e9uticos<\/b><span style=\"font-weight: 400;\"> proporciona informaci\u00f3n esencial para la determinaci\u00f3n de la vida \u00fatil, la especificaci\u00f3n de las condiciones de almacenamiento y la comprensi\u00f3n de las v\u00edas de degradaci\u00f3n. Los programas de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> conformes al <\/span><b>ICH Q1<\/b><span style=\"font-weight: 400;\"> requieren m\u00e9todos anal\u00edticos indicadores de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> validados capaces de detectar toda la gama de <\/span><b>productos de degradaci\u00f3n<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios anal\u00edticos validados para la evaluaci\u00f3n de la <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> y la degradaci\u00f3n, aplicando plataformas <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\"> y <\/span><b>LC-MS\/MS<\/b><span style=\"font-weight: 400;\"> para detectar, cuantificar e identificar <\/span><b>productos de degradaci\u00f3n<\/b><span style=\"font-weight: 400;\">.<\/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;\">M\u00e9todos <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\"> indicadores de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> validados para estudios formales conformes al <\/span><b>ICH Q1<\/b><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detecci\u00f3n y cuantificaci\u00f3n de <\/span><b>productos de degradaci\u00f3n<\/b><span style=\"font-weight: 400;\">.<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identificaci\u00f3n de <\/span><b>productos de degradaci\u00f3n<\/b><span style=\"font-weight: 400;\"> y elucidaci\u00f3n de v\u00edas por <\/span><b>LC-MS\/MS<\/b><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en programas de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> de <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\"> y productos<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cobertura de v\u00edas de degradaci\u00f3n hidrol\u00edtica, oxidativa y de depurinaci\u00f3n<\/span><\/li>\n<p><\/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\">\nOligonucle\u00f3tidos Servicios especializados de caracterizaci\u00f3n anal\u00edtica y control de calidad para sustancias activas y productos de oligonucle\u00f3tidos terap\u00e9uticos. Oligonucle\u00f3tidos terap\u00e9uticos Los oligonucle\u00f3tidos terap\u00e9uticos \u2014oligonucle\u00f3tidos antisentido (ASO), ARN de interferencia peque\u00f1o (ARNi), mim\u00e9ticos e inhibidores de microARN, apt\u00e1meros, oligonucle\u00f3tidos que modulan&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Oligonucle\u00f3tidos\/ No GLP&rdquo;<\/span>&hellip;<\/a><\/div>\n","protected":false},"author":1,"featured_media":4763,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-3864","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3864","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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/comments?post=3864"}],"version-history":[{"count":32,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3864\/revisions"}],"predecessor-version":[{"id":6923,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3864\/revisions\/6923"}],"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=3864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}