{"id":22688,"date":"2022-10-28T07:17:15","date_gmt":"2022-10-28T05:17:15","guid":{"rendered":"https:\/\/kymos.com\/news\/nova-guia-preliminar-de-la-fda-per-a-terapeutiques-amb-oligonucleotids\/"},"modified":"2022-10-28T07:17:15","modified_gmt":"2022-10-28T05:17:15","slug":"nova-guia-preliminar-de-la-fda-per-a-terapeutiques-amb-oligonucleotids","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/nova-guia-preliminar-de-la-fda-per-a-terapeutiques-amb-oligonucleotids\/","title":{"rendered":"Nova guia preliminar de la FDA per a terap\u00e8utiques amb oligonucle\u00f2tids"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">El juny de 2022, la FDA va publicar un esborrany d&#8217;una nova guia sobre <strong>&#8220;<\/strong> <strong>Consideracions de farmacologia cl\u00ednica per al desenvolupament de ter\u00e0pies amb oligonucle\u00f2tids&#8221;.<\/strong> La guia proporciona recomanacions per ajudar la ind\u00fastria en el desenvolupament de ter\u00e0pies amb oligonucle\u00f2tids. Aix\u00f2 planteja nous reptes per als desenvolupadors i fabricants de ter\u00e0pies amb oligonucle\u00f2tids. <strong>Maria Fauth, directora del departament d&#8217;oligonucle\u00f2tids de Kymos<\/strong> , explica de qu\u00e8 tracta la nova guia i com Kymos us pot ajudar a implementar-la. <\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u00abEl nou esborrany de directrius de la FDA se centra en <strong>recomanacions per a<\/strong> <strong>avaluacions farmacocin\u00e8tiques, farmacodin\u00e0miques i de seguretat durant el desenvolupament terap\u00e8utic d&#8217;oligonucle\u00f2tids<\/strong> . A Kymos podem donar suport als nostres clients en totes aquestes activitats\u00bb, comen\u00e7a Maria Fauth amb una primera visi\u00f3 general. <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">El desenvolupament d&#8217;una terap\u00e8utica amb oligonucle\u00f2tids segueix en molts aspectes el desenvolupament de f\u00e0rmacs de mol\u00e8cules petites o productes biol\u00f2gics. No obstant aix\u00f2, les terap\u00e8utiques amb oligonucle\u00f2tids tenen certes caracter\u00edstiques \u00faniques en comparaci\u00f3 amb les mol\u00e8cules petites o els productes biol\u00f2gics que cal tenir en compte. Per exemple, la farmacocin\u00e8tica plasm\u00e0tica de les oligoterap\u00e8utiques pot no reflectir la distribuci\u00f3, la farmacodin\u00e0mica, la seguretat o l&#8217;efic\u00e0cia del teixit diana.  <\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">Maria Fauth descriu com <strong>Kymos us pot facilitar la vida<\/strong> en aquesta etapa de desenvolupament: &#8220;Primer podem <strong>determinar les concentracions plasm\u00e0tiques<\/strong> de l&#8217;agent oligoterap\u00e8utic mitjan\u00e7ant hibridaci\u00f3 ELISA o LC-MS\/MS amb m\u00e8todes bioanal\u00edtics segons GLP. A continuaci\u00f3, realitzem l&#8217; <strong>avaluaci\u00f3 farmacocin\u00e8tica<\/strong> amb el nostre programari validat WinNonLin. En cas que la farmacocin\u00e8tica plasm\u00e0tica no sigui suficient, a Kymos tamb\u00e9 podem <strong>quantificar els biomarcadors farmacodin\u00e0mics necessaris<\/strong> de manera r\u00e0pida i senzilla mitjan\u00e7ant el nostre sistema ECLA d&#8217;\u00faltima generaci\u00f3&#8221;.  <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">De fet, tot el viatge va comen\u00e7ar exactament amb aquesta determinaci\u00f3 de biomarcadors.<\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u00abVam recon\u00e8ixer la necessitat de m\u00e8todes bioanal\u00edtics reprodu\u00efbles fa anys. I vam actuar en conseq\u00fc\u00e8ncia\u00bb, explica Maria Fauth. \u00abJa el 2017 vam comen\u00e7ar a desenvolupar i validar m\u00e8todes bioanal\u00edtics compatibles amb GLP per a miRNAs de biomarcadors mitjan\u00e7ant qPCR en diferents teixits i biofluids. En els anys posteriors, hem ampliat el nostre espectre per incloure altres \u00e0cids nucleics i \u00e0rees d&#8217;aplicaci\u00f3. Ara ens sentim confirmats, ja que la <strong>FDA assenyala expl\u00edcitament la necessitat de m\u00e8todes bioanal\u00edtics validats<\/strong> en aquesta nova guia\u00bb.   <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">No obstant aix\u00f2, la FDA va un pas m\u00e9s enll\u00e0. En el nou esborrany de directrius, emfatitzen que les noves modificacions qu\u00edmiques i altres <strong>ter\u00e0pies d&#8217;oligonucle\u00f2tids poden provocar respostes immunit\u00e0ries adverses<\/strong> . Per tant, els immunoassajos dels oligonucle\u00f2tids, per\u00f2 especialment dels components transportadors i els conjugats d&#8217;oligonucle\u00f2tids amb lligands dirigits a prote\u00efnes, s\u00f3n essencials.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En resposta a la recomanaci\u00f3 de la FDA, Maria Fauth ofereix una breu descripci\u00f3 de l&#8217;\u00e0mplia experi\u00e8ncia de Kymos amb la immunogenicitat.<\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u00ab <strong>Tenim dues seus, una a Barcelona i una altra a Frankfurt, dedicades a la determinaci\u00f3 de la immunogenicitat.<\/strong> Els meus col\u00b7legues, amb molta experi\u00e8ncia, estan preparats per ajudar-vos amb qualsevol problema d&#8217;immunogenicitat que pugui sorgir durant el vostre desenvolupament.\u00bb<\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">En conclusi\u00f3, tot l&#8217;equip de Kymos estar\u00e0 encantat d&#8217;assessorar-vos sobre la implementaci\u00f3 de la guia i donar-vos suport en el desenvolupament de les vostres ter\u00e0pies amb oligonucle\u00f2tids. Per a m\u00e9s informaci\u00f3, poseu-vos en contacte amb nosaltres a <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a> . <strong>Tamb\u00e9 podeu con\u00e8ixer Maria Fauth en persona al TIDES, del 16 al 18 de novembre a Viena, \u00c0ustria.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Per a la vostra comoditat, podeu trobar la guia completa <a href=\"https:\/\/www.fda.gov\/media\/159414\/download\" data-wpel-link=\"external\">aqu\u00ed<\/a> .<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El juny de 2022, la FDA va publicar un esborrany  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":15286,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95,97],"tags":[],"class_list":["post-22688","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","category-cmc-ca"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Terap\u00e8utica d&#039;oligonucle\u00f2tids | Nova guia de la FDA<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre el nou esborrany de la guia de la FDA per a terap\u00e8utiques amb oligonucle\u00f2tids publicada el juny de 2022. 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