{"id":6489,"date":"2026-09-13T17:36:37","date_gmt":"2026-09-13T15:36:37","guid":{"rendered":"https:\/\/amsbiopharma.com\/inmunogenicidad\/"},"modified":"2026-09-23T14:58:11","modified_gmt":"2026-09-23T12:58:11","slug":"inmunogenicidad","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/inmunogenicidad\/","title":{"rendered":"Inmunogenicidad"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6489\" class=\"elementor elementor-6489 elementor-6484\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1a2acea8 e-flex e-con-boxed e-con e-parent\" data-id=\"1a2acea8\" 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-292da77a e-con-full e-flex e-con e-child\" data-id=\"292da77a\" 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-1c9a1f9d e-con-full e-flex e-con e-child\" data-id=\"1c9a1f9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a6483c1 elementor-widget elementor-widget-heading\" data-id=\"a6483c1\" 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\">Inmunogenicidad<\/h1>\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-61d112e5 e-con-full e-flex e-con e-child\" data-id=\"61d112e5\" 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\\\/Clip10_Bioanalysis_Biomarkers.mp4&quot;,&quot;background_video_end&quot;:30}\">\n\t\t<div class=\"elementor-background-video-container elementor-hidden-mobile\">\n\t\t\t\t\t\t\t<video class=\"elementor-background-video-hosted\" role=\"presentation\" autoplay muted playsinline loop><\/video>\n\t\t\t\t\t<\/div><div class=\"elementor-element elementor-element-e7e54a3 e-con-full e-flex e-con e-child\" data-id=\"e7e54a3\" 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\\\/Clip10_Bioanalysis_Biomarkers2.mp4&quot;,&quot;background_play_on_mobile&quot;:&quot;yes&quot;,&quot;background_play_once&quot;:&quot;yes&quot;,&quot;background_video_end&quot;:13,&quot;background_video_start&quot;:0}\">\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-8e2d49b e-flex e-con-boxed e-con e-parent\" data-id=\"8e2d49b\" 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-2ce3633 e-con-full e-flex e-con e-child\" data-id=\"2ce3633\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1cf95f4 elementor-widget elementor-widget-heading\" data-id=\"1cf95f4\" 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\">Servicios de evaluaci\u00f3n de inmunogenicidad para terap\u00e9uticos biol\u00f3gicos.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6afdf6 elementor-widget elementor-widget-text-editor\" data-id=\"d6afdf6\" 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 <\/span><b>inmunogenicidad<\/b><span style=\"font-weight: 400;\"> es una consideraci\u00f3n cr\u00edtica de seguridad y eficacia para todo terap\u00e9utico biol\u00f3gico. El potencial de un f\u00e1rmaco para desencadenar una respuesta inmune no deseada \u2014desde la formaci\u00f3n transitoria de anticuerpos hasta respuestas de <\/span><b>anticuerpos neutralizantes<\/b><span style=\"font-weight: 400;\"> que anulan la eficacia terap\u00e9utica\u2014 debe evaluarse y monitorizarse rigurosamente a lo largo de todo el ciclo de desarrollo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios validados de evaluaci\u00f3n de <\/span><b>inmunogenicidad<\/b><span style=\"font-weight: 400;\"> para anticuerpos monoclonales, anticuerpos bioespec\u00edficos, prote\u00ednas de fusi\u00f3n Fc, enzimas terap\u00e9uticas, p\u00e9ptidos terap\u00e9uticos, vectores de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\"> y medicamentos de terapia avanzada (<\/span><b>ATMP<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Todos los ensayos se desarrollan y validan conforme a la gu\u00eda de la <\/span><b>EMA<\/b><span style=\"font-weight: 400;\"> sobre evaluaci\u00f3n de <\/span><b>inmunogenicidad<\/b><span style=\"font-weight: 400;\"> de prote\u00ednas terap\u00e9uticas, la gu\u00eda de la <\/span><b>FDA<\/b><span style=\"font-weight: 400;\"> y las directrices <\/span><b>ICH<\/b><span style=\"font-weight: 400;\"> aplicables. <\/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-a2cd724 e-con-full e-flex e-con e-child\" data-id=\"a2cd724\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3604d60 elementor-widget elementor-widget-image\" data-id=\"3604d60\" 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=\"900\" height=\"771\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/img.png\" class=\"attachment-large size-large wp-image-3616\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/img.png 900w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/img-300x257.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/img-768x658.png 768w\" sizes=\"(max-width: 900px) 100vw, 900px\" \/>\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-569a767 e-con-full e-flex e-con e-parent\" data-id=\"569a767\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-60d507a e-con-full title-container e-flex e-con e-child\" data-id=\"60d507a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad48d71 elementor-widget elementor-widget-heading\" data-id=\"ad48d71\" 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\">Discover<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-461c7f6 elementor-widget elementor-widget-html\" data-id=\"461c7f6\" 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-277ed7c elementor-nav-menu--dropdown-none discover-menu elementor-widget elementor-widget-nav-menu\" data-id=\"277ed7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;layout&quot;:&quot;vertical&quot;,&quot;submenu_icon&quot;:{&quot;value&quot;:&quot;&lt;svg aria-hidden=\\&quot;true\\&quot; 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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-1320\" 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-1320\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Determinaci\u00f3n de Anticuerpos Anti-F\u00e1rmaco de Uni\u00f3n (ADA) \/ 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-1320\" class=\"elementor-element elementor-element-056bc1f e-con-full e-flex e-con e-child\" data-id=\"056bc1f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1320\" class=\"elementor-element elementor-element-b52d03b e-flex e-con-boxed e-con e-child\" data-id=\"b52d03b\" 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-af6900e elementor-widget elementor-widget-text-editor\" data-id=\"af6900e\" 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 detecci\u00f3n de <\/span><b>anticuerpos anti-f\u00e1rmaco<\/b><span style=\"font-weight: 400;\"> (<\/span><b>ADA<\/b><span style=\"font-weight: 400;\">) es el pilar fundamental de los programas de evaluaci\u00f3n de <\/span><b>inmunogenicidad<\/b><span style=\"font-weight: 400;\">. Un ensayo <\/span><b>ADA<\/b><span style=\"font-weight: 400;\"> bien dise\u00f1ado y validado debe detectar anticuerpos con suficiente sensibilidad y tolerancia al f\u00e1rmaco para proporcionar datos cl\u00ednicos significativos, mientras mantiene la especificidad para distinguir resultados verdaderos positivos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Desarrollamos y validamos ensayos <\/span><b>ADA<\/b><span style=\"font-weight: 400;\"> aplicando el enfoque por niveles recomendado por la <\/span><b>EMA<\/b><span style=\"font-weight: 400;\"> y la <\/span><b>FDA<\/b><span style=\"font-weight: 400;\">: cribado, confirmaci\u00f3n y determinaci\u00f3n de t\u00edtulo. Los formatos de ensayo se seleccionan seg\u00fan las propiedades de la mol\u00e9cula del f\u00e1rmaco, con puntos de corte determinados mediante el enfoque estad\u00edstico requerido por las directrices regulatorias vigentes.<\/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;\">Estrategia de <\/span><b>ADA<\/b><span style=\"font-weight: 400;\"> por niveles: <\/span><span style=\"font-weight: 400;\">cribado, confirmaci\u00f3n<\/span><span style=\"font-weight: 400;\"> y titulaci\u00f3n<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en <\/span><b>mAbs<\/b><span style=\"font-weight: 400;\">, bioespec\u00edficos, p\u00e9ptidos terap\u00e9uticos y <\/span><b>ATMP<\/b><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validaci\u00f3n completa cubriendo sensibilidad, <\/span><span style=\"font-weight: 400;\">tolerancia al f\u00e1rmaco<\/span><span style=\"font-weight: 400;\"> y especificidad<\/span><\/li>\n<p> \t<\/p>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documentaci\u00f3n alineada con las gu\u00edas de la <\/span><b>EMA<\/b><span style=\"font-weight: 400;\"> y la <\/span><b>FDA<\/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<\/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\">\nInmunogenicidad Servicios de evaluaci\u00f3n de inmunogenicidad para terap\u00e9uticos biol\u00f3gicos. La inmunogenicidad es una consideraci\u00f3n cr\u00edtica de seguridad y eficacia para todo terap\u00e9utico biol\u00f3gico. El potencial de un f\u00e1rmaco para desencadenar una respuesta inmune no deseada \u2014desde la formaci\u00f3n transitoria de&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/inmunogenicidad\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Inmunogenicidad&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-6489","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6489","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=6489"}],"version-history":[{"count":5,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6489\/revisions"}],"predecessor-version":[{"id":6895,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6489\/revisions\/6895"}],"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=6489"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}