{"id":6529,"date":"2026-09-14T14:27:20","date_gmt":"2026-09-14T12:27:20","guid":{"rendered":"https:\/\/amsbiopharma.com\/servicios-de-biosimilares\/"},"modified":"2026-09-15T16:09:37","modified_gmt":"2026-09-15T14:09:37","slug":"servicios-de-biosimilares","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/servicios-de-biosimilares\/","title":{"rendered":"Servicios de Biosimilares"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6529\" class=\"elementor elementor-6529 elementor-6524\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-529808f1 e-flex e-con-boxed e-con e-parent\" data-id=\"529808f1\" 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-14eb4db2 e-con-full e-flex e-con e-child\" data-id=\"14eb4db2\" 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-319d4074 e-con-full e-flex e-con e-child\" data-id=\"319d4074\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-16b20f57 elementor-widget elementor-widget-heading\" data-id=\"16b20f57\" 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\">Servicios de Biosimilares\/ GMP<\/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-680db4f1 e-con-full e-flex e-con e-child\" data-id=\"680db4f1\" 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-7c5d6103 e-con-full e-flex e-con e-child\" data-id=\"7c5d6103\" 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_start&quot;:0,&quot;background_video_end&quot;:40,&quot;background_play_once&quot;:&quot;yes&quot;,&quot;background_play_on_mobile&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-dbaef48 e-flex e-con-boxed e-con e-parent\" data-id=\"dbaef48\" 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-f21da2b e-con-full e-flex e-con e-child\" data-id=\"f21da2b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b8a6d92 elementor-widget elementor-widget-heading\" data-id=\"b8a6d92\" 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 integrales de comparabilidad y caracterizaci\u00f3n anal\u00edtica para el desarrollo y la aprobaci\u00f3n regulatoria de biosimilares.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de319d2 elementor-widget elementor-widget-text-editor\" data-id=\"de319d2\" 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 desarrollo de un <\/span><b>biosimilar<\/b><span style=\"font-weight: 400;\"> requiere un programa anal\u00edtico mucho m\u00e1s extenso que el requerido para un medicamento gen\u00e9rico convencional. Demostrar la <\/span><b>biosimilitud<\/b><span style=\"font-weight: 400;\"> con el medicamento de referencia exige un ejercicio de <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> anal\u00edtica integral que cubre una amplia gama de <\/span><b>atributos de calidad<\/b><span style=\"font-weight: 400;\"> fisicoqu\u00edmicos, estructurales y funcionales usando m\u00faltiples m\u00e9todos ortogonales. El paquete de datos anal\u00edticos es la piedra angular del expediente regulatorio del <\/span><b>biosimilar<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La <\/span><b>EMA<\/b><span style=\"font-weight: 400;\">, la <\/span><b>FDA<\/b><span style=\"font-weight: 400;\"> y la <\/span><b>ICH<\/b><span style=\"font-weight: 400;\"> han publicado directrices detalladas que definen los requisitos anal\u00edticos para el desarrollo de <\/span><b>biosimilares<\/b><span style=\"font-weight: 400;\">, enfatizando un enfoque escalonado de totalidad de la evidencia en el que un paquete s\u00f3lido de <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> anal\u00edtica puede reducir o eliminar la necesidad de estudios cl\u00ednicos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios integrados de <\/span><b>caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> y <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> de <\/span><b>biosimilares<\/b><span style=\"font-weight: 400;\">, ofreciendo la experiencia anal\u00edtica y las metodolog\u00edas validadas necesarias para generar un paquete de datos de <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> s\u00f3lido y de calidad 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<div class=\"elementor-element elementor-element-f1f6812 e-con-full e-flex e-con e-child\" data-id=\"f1f6812\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1f08986 elementor-widget elementor-widget-image\" data-id=\"1f08986\" 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=\"772\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/di.png\" class=\"attachment-large size-large wp-image-3644\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/di.png 901w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/di-300x257.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/di-768x658.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-7645832e e-con-full e-flex e-con e-parent\" data-id=\"7645832e\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-1446ee73 e-con-full title-container e-flex e-con e-child\" data-id=\"1446ee73\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1a2cbe6 elementor-widget elementor-widget-heading\" data-id=\"1a2cbe6\" 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-79645f08 elementor-widget elementor-widget-html\" data-id=\"79645f08\" 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-7c366ba6 elementor-nav-menu--dropdown-none discover-menu elementor-nav-menu__align-start elementor-widget__width-initial elementor-widget elementor-widget-nav-menu\" data-id=\"7c366ba6\" 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; class=\\&quot;e-font-icon-svg e-fas-caret-down\\&quot; viewBox=\\&quot;0 0 320 512\\&quot; xmlns=\\&quot;http:\\\/\\\/www.w3.org\\\/2000\\\/svg\\&quot;&gt;&lt;path d=\\&quot;M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\\&quot;&gt;&lt;\\\/path&gt;&lt;\\\/svg&gt;&quot;,&quot;library&quot;:&quot;fa-solid&quot;}}\" data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Men\u00fa\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-underline e--animation-fade\">\n\t\t\t\t<ul id=\"menu-1-7c366ba6\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\">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\">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\">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\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<nav class=\"elementor-nav-menu--dropdown elementor-nav-menu__container\" aria-hidden=\"true\">\n\t\t\t\t<ul id=\"menu-2-7c366ba6\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\" tabindex=\"-1\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\" tabindex=\"-1\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a 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 href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\" tabindex=\"-1\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\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-0bd97f2 e-con-full e-flex e-con e-parent\" data-id=\"0bd97f2\" 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-85c367d e-con-full e-flex e-con e-child\" data-id=\"85c367d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0e48442 elementor-widget elementor-widget-heading\" data-id=\"0e48442\" 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\">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-b49a327 e-con-full e-grid e-con e-child\" data-id=\"b49a327\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b9e75d8 elementor-widget elementor-widget-image\" data-id=\"b9e75d8\" 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=\"901\" height=\"365\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/people.png\" class=\"attachment-full size-full wp-image-3733\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/people.png 901w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/people-300x122.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/people-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 class=\"elementor-element elementor-element-38befd9 elementor-widget elementor-widget-n-accordion\" data-id=\"38befd9\" 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-5950\" 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-5950\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Caracterizaci\u00f3n y Comparabilidad de Biosimilares (identidad, contenido, prote\u00edna, impurezas) <\/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-5950\" class=\"elementor-element elementor-element-babffe6 e-con-full e-flex e-con e-child\" data-id=\"babffe6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-5950\" class=\"elementor-element elementor-element-bd7f696 e-flex e-con-boxed e-con e-child\" data-id=\"bd7f696\" 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-5099fc7 elementor-widget elementor-widget-text-editor\" data-id=\"5099fc7\" 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;\">Demostrar la <\/span><b>biosimilitud<\/b><span style=\"font-weight: 400;\"> requiere un programa de <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> anal\u00edtica integral que compare sistem\u00e1ticamente el <\/span><b>biosimilar<\/b><span style=\"font-weight: 400;\"> propuesto y el medicamento de referencia en todos los <\/span><b>atributos de calidad<\/b><span style=\"font-weight: 400;\"> relevantes, usando los m\u00e9todos m\u00e1s sensibles y discriminantes disponibles. El ejercicio debe cubrir la estructura primaria, la estructura de orden superior, las modificaciones post-traduccionales, las propiedades fisicoqu\u00edmicas, la pureza, los perfiles de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\">, el estado de <\/span><b>agregaci\u00f3n<\/b><span style=\"font-weight: 400;\">, la heterogeneidad de carga y la actividad funcional.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios integrados de <\/span><b>caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> y <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> cubriendo todos los <\/span><b>atributos de calidad<\/b><span style=\"font-weight: 400;\"> requeridos. La identidad se confirma por an\u00e1lisis de la estructura primaria y <\/span><b>mapeo pept\u00eddico<\/b><span style=\"font-weight: 400;\">. El contenido proteico se determina por m\u00e9todos cuantitativos validados. La pureza y los perfiles de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> se caracterizan por <\/span><b>HPLC<\/b><span style=\"font-weight: 400;\">, <\/span><b>CE<\/b><span style=\"font-weight: 400;\"> y t\u00e9cnicas espectrom\u00e9tricas. La <\/span><b>glicosilaci\u00f3n<\/b><span style=\"font-weight: 400;\"> se perfila mediante an\u00e1lisis de glicanos liberados. La heterogeneidad de carga y tama\u00f1o se eval\u00faa por <\/span><b>IEX<\/b><span style=\"font-weight: 400;\">, <\/span><b>IEF<\/b><span style=\"font-weight: 400;\"> y <\/span><b>SEC<\/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 la estructura primaria e integridad de secuencia por <\/span><b>mapeo pept\u00eddico<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determinaci\u00f3n del contenido proteico por m\u00e9todos cuantitativos validados<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Perfilado de pureza y <\/span><b>agregaci\u00f3n<\/b><span style=\"font-weight: 400;\"> por m\u00faltiples m\u00e9todos ortogonales<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Caracterizaci\u00f3n de la glicosilaci\u00f3n<\/b><span style=\"font-weight: 400;\"> por perfilado de glicanos liberados y mapeo de glucop\u00e9ptidos<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Caracterizaci\u00f3n<\/b><span style=\"font-weight: 400;\"> de actividad funcional y de uni\u00f3n para <\/span><b>comparabilidad<\/b><span style=\"font-weight: 400;\"> biol\u00f3gica<\/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\">\nServicios de Biosimilares\/ GMP Servicios integrales de comparabilidad y caracterizaci\u00f3n anal\u00edtica para el desarrollo y la aprobaci\u00f3n regulatoria de biosimilares. El desarrollo de un biosimilar requiere un programa anal\u00edtico mucho m\u00e1s extenso que el requerido para un medicamento gen\u00e9rico convencional.&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/servicios-de-biosimilares\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Servicios de Biosimilares&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-6529","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6529","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=6529"}],"version-history":[{"count":3,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6529\/revisions"}],"predecessor-version":[{"id":6614,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/6529\/revisions\/6614"}],"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=6529"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}