{"id":24058,"date":"2025-09-02T12:10:01","date_gmt":"2025-09-02T10:10:01","guid":{"rendered":"https:\/\/kymos.com\/?p=24058"},"modified":"2025-12-03T19:05:13","modified_gmt":"2025-12-03T18:05:13","slug":"analisi-anticossos-neutralitzants","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/analisi-anticossos-neutralitzants\/","title":{"rendered":"Anticossos neutralitzants: an\u00e0lisi, directrius i impacte per als productes biol\u00f2gics"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\"><strong>Els productes biol\u00f2gics i els medicaments de ter\u00e0pies avan\u00e7ades (MTPA)<\/strong> estan revolucionant el futur de la medicina, i la seva seguretat i efic\u00e0cia s\u00f3n dues prioritats principals. Un aspecte clau d&#8217;aquest proc\u00e9s \u00e9s la <strong>resposta immunit\u00e0ria que poden desencadenar<\/strong> , especialment la <strong>generaci\u00f3 d&#8217;anticossos neutralitzants (NAbs)<\/strong> . Aquests anticossos tenen un impacte important en el rendiment dels f\u00e0rmacs; poden alterar i fins i tot inhibir la seva acci\u00f3 terap\u00e8utica; per tant, les proves d&#8217;immunogenicitat s\u00f3n un aspecte crucial del desenvolupament de productes biol\u00f2gics i MTPA. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En aquest article, recapitulem <strong>qu\u00e8 s\u00f3n els anticossos neutralitzants<\/strong> , per qu\u00e8 \u00e9s important fer-ne proves, <strong>com es detecten<\/strong> , les <strong>directrius<\/strong> actuals a seguir per a les seves proves i <strong>com Kymos pot donar suport a les vostres necessitats de proves de NAb<\/strong> .<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Qu\u00e8 s\u00f3n els anticossos neutralitzants?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>Els anticossos neutralitzants s\u00f3n un tipus espec\u00edfic d&#8217;anticossos antif\u00e0rmacs (ADA)<\/strong> . Mentre que els ADA d&#8217;uni\u00f3 s&#8217;uneixen a la mol\u00e8cula terap\u00e8utica sense afectar necess\u00e0riament la seva funci\u00f3, <strong>els NAbs bloquegen l&#8217;activitat biol\u00f2gica del f\u00e0rmac, alterant potencialment la seva efic\u00e0cia<\/strong> . <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">La seva pres\u00e8ncia pot conduir a una resposta terap\u00e8utica redu\u00efda, frac\u00e0s del tractament o fins i tot efectes adversos, especialment en r\u00e8gims de dosificaci\u00f3 a llarg termini o repetits. Per aquestes raons, <strong>la identificaci\u00f3 i caracteritzaci\u00f3 dels NAbs \u00e9s essencial durant el desenvolupament de f\u00e0rmacs<\/strong> . <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Quan \u00e9s necess\u00e0ria la prova de NAb?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">La prova de NAb normalment es <strong>requereix per a qualsevol producte que tingui el potencial d&#8217;induir una resposta immunit\u00e0ria<\/strong> , incloent-hi:<\/span><\/p>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">Anticossos monoclonals (mAb)<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Prote\u00efnes terap\u00e8utiques<\/strong> com ara enzims, hormones o citocines<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Ter\u00e0pies g\u00e8niques<\/strong> i <strong>ter\u00e0pies basades en oligonucle\u00f2tids<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Virus oncol\u00edtics<\/strong> i <strong>ter\u00e0pies basades en vectors virals<\/strong><\/span><\/li>\n<li><strong><span style=\"font-size: 14pt;\">Biosimilars<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Vacunes<\/strong> (centrades en la resposta de protecci\u00f3 immunit\u00e0ria)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">La creixent complexitat d&#8217;aquestes modalitats terap\u00e8utiques ha fet que les proves de NAb siguin m\u00e9s rellevants i continuaran creixent en els propers anys.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Com es detecten els anticossos neutralitzants?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>La detecci\u00f3 de NAb normalment segueix una estrat\u00e8gia de diversos passos dins d&#8217;un marc m\u00e9s ampli de proves d&#8217;immunogenicitat<\/strong> . El proc\u00e9s sol incloure: <\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"> <strong>Cribratge d&#8217;ADA mitjan\u00e7ant un assaig de fixaci\u00f3 de lligands pont (per exemple, ELISA o ECLA<\/strong> ). Es detecten tant anticossos de fixaci\u00f3 com neutralitzants, per\u00f2 no es diferencien en aquesta etapa. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Prova confirmat\u00f2ria de mostres positives<\/strong> per determinar l&#8217;especificitat a la mol\u00e8cula terap\u00e8utica mitjan\u00e7ant un assaig competitiu d&#8217;uni\u00f3 a lligands.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Titraci\u00f3 per avaluar semiquantitativament la concentraci\u00f3 d&#8217;ADA<\/strong> mitjan\u00e7ant assaig d&#8217;uni\u00f3 a lligands.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Proves de NAb nom\u00e9s en mostres confirmades positives per a l&#8217;ADA per determinar el seu impacte funcional sobre el f\u00e0rmac<\/strong> . En aquest cas, <strong>s&#8217;utilitzen dos formats generals d&#8217;assaigs per a les proves de NAb<\/strong> : <\/span><\/li>\n<\/ol>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Assajos basats en c\u00e8l\u00b7lules (CBA): <\/strong><\/span><span style=\"font-size: 14pt;\">Aquests tipus d&#8217;assajos es consideren <strong>el patr\u00f3 d&#8217;or perqu\u00e8 proporcionen una avaluaci\u00f3 quantitativa de la inhibici\u00f3 funcional de l&#8217;activitat biol\u00f2gica del f\u00e0rmac<\/strong> en un sistema cel\u00b7lular (per exemple, creixement cel\u00b7lular, apoptosi o assaigs de gens reporters). La seva rellev\u00e0ncia fisiol\u00f2gica els converteix en l&#8217;opci\u00f3 preferida per la majoria d&#8217;ag\u00e8ncies reguladores. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Assajos d&#8217;uni\u00f3 a lligands (LBA):<\/strong> Aquests no es basen en c\u00e8l\u00b7lules i <strong>s&#8217;utilitzen normalment quan els CBA no s\u00f3n factibles<\/strong> . Els LBA solen ser assaigs d&#8217;uni\u00f3 competitius i, tot i que s\u00f3n m\u00e9s r\u00e0pids de realitzar, <strong>poden ser menys predictius de l&#8217;activitat neutralitzant in vivo<\/strong> . <\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><strong>Quines directrius s&#8217;apliquen a la determinaci\u00f3 de NAb?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Les proves d&#8217;anticossos neutralitzants es regeixen per marcs i directrius reguladores establertes. Les m\u00e9s rellevants s\u00f3n: <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>FDA (2019)<\/strong> \u2013 <em>Proves d&#8217;immunogenicitat de productes proteics terap\u00e8utics<\/em> : <strong>recomana un enfocament basat en el risc i d\u00f3na suport a les proves de beneficis terap\u00e8utics (CBA) com a m\u00e8tode preferit<\/strong> . La guia suggereix <strong>la validaci\u00f3 de les CBA,<\/strong> incloent-hi la sensibilitat, l&#8217;especificitat i la toler\u00e0ncia als f\u00e0rmacs. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>EMA (2017)<\/strong> \u2013 <em>Guia sobre l&#8217;avaluaci\u00f3 de la immunogenicitat de prote\u00efnes terap\u00e8utiques derivades de la biotecnologia<\/em> : destaca la import\u00e0ncia de la determinaci\u00f3 de NAb en el mecanisme d&#8217;acci\u00f3 del f\u00e0rmac. <strong>Aquesta guia requereix proves de NAb si es detecten ADA i es consideren potencialment cl\u00ednicament rellevants.<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>ICH S6(R1) (2011)<\/strong> : se centra en <strong>consideracions d&#8217;immunogenicitat precl\u00ednica<\/strong> i d\u00f3na suport a <strong>l&#8217;avaluaci\u00f3 basada en el risc en les primeres etapes de desenvolupament.<\/strong><\/span><\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><strong>Conclusi\u00f3: una eina cr\u00edtica en el desenvolupament de productes biol\u00f2gics<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>La determinaci\u00f3 de NAb<\/strong> \u00e9s un pas cr\u00edtic en el desenvolupament i el seguiment de ter\u00e0pies biol\u00f2giques, una eina que <strong>garanteix la seguretat, l&#8217;efic\u00e0cia i la consist\u00e8ncia terap\u00e8utica en el desenvolupament de ter\u00e0pies biol\u00f2giques<\/strong> . Amb l&#8217;auge de noves modalitats de ter\u00e0pies com ara els tractaments g\u00e8nics i cel\u00b7lulars, comprendre i mitigar la immunogenicitat \u00e9s i ser\u00e0 <strong>essencial per a l&#8217;efic\u00e0cia dels f\u00e0rmacs i la seguretat dels pacients<\/strong> . <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Integrar una estrat\u00e8gia d&#8217;immunogenicitat robusta en les primeres etapes del desenvolupament<\/strong> (i refinar-la en etapes posteriors) pot <strong>reduir significativament el risc de fracassos en etapes avan\u00e7ades, accelerar el temps de comercialitzaci\u00f3 i donar suport a l&#8217;aprovaci\u00f3 reguladora<\/strong> . Per aquest motiu, tenir un soci de confian\u00e7a \u00e9s vital. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Com pot Kymos donar suport als vostres estudis d&#8217;immunogenicitat?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">A Kymos Group, <strong>oferim un suport integral per a les proves d&#8217;immunogenicitat en totes les etapes de desenvolupament<\/strong> , des de les primeres etapes d&#8217;R+D fins a les fases cl\u00edniques pivotals. Amb l&#8217;obertura del nostre <strong>nou Laboratori d&#8217;Assajos Cel\u00b7lulars GLP a Alemanya<\/strong> , hem ampliat significativament les nostres capacitats en productes biol\u00f2gics, incloent-hi: <\/span><\/p>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">Perfil complet d&#8217;immunogenicitat:<\/span><\/strong>\n<ul>\n<li><span style=\"font-size: 14pt;\">Anticossos antif\u00e0rmacs d&#8217;uni\u00f3 ( <strong>ADA<\/strong> )<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Anticossos neutralitzants ( <strong>NAbs<\/strong> )<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Expertesa en<\/strong> :<\/span>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">Anticossos monoclonals innovadors<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">Biosimilars<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">P\u00e8ptids terap\u00e8utics<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">Oligonucle\u00f2tids<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Vectors virals<\/strong> <strong>i virus oncol\u00edtics<\/strong><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Els nostres <strong>equips, tant a Alemanya com a Espanya,<\/strong> poden donar suport <strong>a la implementaci\u00f3<\/strong> , <strong>validaci\u00f3<\/strong> o <strong>desenvolupament complet d&#8217;assajos de m\u00e8todes des de zero<\/strong> , tot <strong>d&#8217;acord amb les directrius bioanal\u00edtiques de l&#8217;EMA i la FDA<\/strong> . Tant si el vostre estudi requereix una exploraci\u00f3 adequada per al seu prop\u00f2sit com si compleix plenament les normes <strong>en condicions de GLP<\/strong> , Kymos ofereix solucions personalitzades i basades en la ci\u00e8ncia a tot Europa. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">M\u00e9s informaci\u00f3 sobre els nostres serveis d&#8217;immunogenicitat i anticossos neutralitzants:<\/span> <a href=\"https:\/\/kymos.com\/ca\/serveis\/serveis-preclinics-i-clinics\/bioanalisi-i-immunogenicitat-de-productes-biologics-i-biosimilars\/\" data-wpel-link=\"internal\"><span style=\"font-size: 14pt;\">https:\/\/kymos.com\/services\/pre-clinical-clinical-services\/bioanalysis-immunogenicity-of-biologics-biosimilars\/<\/span><\/a><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Bibliografia<\/strong><\/span><\/h2>\n<ol>\n<li><span style=\"font-size: 14pt;\">Departament de Salut i Serveis Humans dels Estats Units. Administraci\u00f3 d&#8217;Aliments i Medicaments. Centre per a l&#8217;Avaluaci\u00f3 i Recerca de Medicaments (CDER). Centre per a l&#8217;Avaluaci\u00f3 i Recerca de Biol\u00f2gics (CBER) <strong>.<\/strong> <strong>Proves d&#8217;immunogenicitat de productes proteics terap\u00e8utics: desenvolupament i validaci\u00f3 d&#8217;assajos per a la detecci\u00f3 d&#8217;anticossos antif\u00e0rmacs. Guia per a la ind\u00fastria (2019) <\/strong><a href=\"https:\/\/www.fda.gov\/media\/119788\/download\" data-wpel-link=\"external\">https:\/\/www.fda.gov\/media\/119788\/download<\/a><\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Comit\u00e8 de Medicaments d&#8217;\u00das Hum\u00e0 (CHMP). <strong>Guia sobre l&#8217;avaluaci\u00f3 de la immunogenicitat de prote\u00efnes terap\u00e8utiques (2017)<\/strong> . <em><u>EMEA\/CHMP\/BMWP\/14327\/2006 Rev 1.<\/u><\/em> <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf\" data-wpel-link=\"external\">https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf<\/a><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"> <strong>Directrius ICH S6 (R1): avaluaci\u00f3 precl\u00ednica de la seguretat dels productes farmac\u00e8utics derivats de la biotecnologia (2011)<\/strong> <em><u>EMA\/CHMP\/ICH\/731268\/1998.<\/u><\/em><\/span><\/li>\n<\/ol>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":24069,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95],"tags":[67],"class_list":["post-24058","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anticossos neutralitzants: proves i directrius per a productes biol\u00f2gics<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre els anticossos neutralitzants (NAbs), com s&#039;estan provant, les seves directrius rellevants i el seu impacte en el mercat dels productes 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