{"id":40008,"date":"2026-05-25T13:54:17","date_gmt":"2026-05-25T11:54:17","guid":{"rendered":"https:\/\/kymos.com\/news\/estudis-de-biodistribucio-i-eliminacio-shedding-per-a-atmp-i-terapies-geniques-preguntes-frequents-practiques\/"},"modified":"2026-05-25T14:06:27","modified_gmt":"2026-05-25T12:06:27","slug":"estudis-de-biodistribucio-i-eliminacio-shedding-per-a-atmp-i-terapies-geniques-preguntes-frequents-practiques","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/estudis-de-biodistribucio-i-eliminacio-shedding-per-a-atmp-i-terapies-geniques-preguntes-frequents-practiques\/","title":{"rendered":"Estudis de biodistribuci\u00f3 i eliminaci\u00f3 (shedding) per a ATMP i ter\u00e0pies g\u00e8niques: preguntes freq\u00fcents pr\u00e0ctiques"},"content":{"rendered":"

Els medicaments de ter\u00e0pia avan\u00e7ada (ATMP), els vectors virals i altres modalitats terap\u00e8utiques emergents estan transformant el desenvolupament de f\u00e0rmacs. A mesura que aquestes ter\u00e0pies es tornen m\u00e9s complexes, comprendre com es distribueixen dins del cos i si es poden alliberar al medi ambient esdev\u00e9 essencial<\/strong> tant per al compliment normatiu com per a la seguretat del pacient. <\/span><\/p>\n

Els estudis de biodistribuci\u00f3 i d’eliminaci\u00f3 (shedding) tenen un paper cr\u00edtic al llarg del desenvolupament precl\u00ednic i cl\u00ednic.<\/strong> Aquesta visi\u00f3 general en format de preguntes freq\u00fcents explica el seu prop\u00f2sit, les difer\u00e8ncies, les expectatives reguladores i els enfocaments anal\u00edtics utilitzats habitualment per donar suport a aquests estudis.<\/span><\/p>\n

Punts clau<\/h2>\n
    \n
  • Els estudis de biodistribuci\u00f3 avaluen com es distribueixen els productes terap\u00e8utics per tot el cos.<\/strong><\/span><\/li>\n
  • Els estudis d’eliminaci\u00f3 (shedding) avaluen si un producte es pot alliberar dels individus tractats<\/strong>.<\/span><\/li>\n
  • Aquests estudis s\u00f3n especialment importants per als ATMP i les ter\u00e0pies basades en virus o bacteris<\/strong>.<\/span><\/li>\n
  • Les ag\u00e8ncies reguladores, incloses l’FDA, l’EMA i l’ICH, proporcionen guies per a l’avaluaci\u00f3 de la biodistribuci\u00f3 i l’eliminaci\u00f3.<\/strong><\/span><\/li>\n
  • Els m\u00e8todes anal\u00edtics robustos s\u00f3n essencials<\/strong> per donar suport a les avaluacions de seguretat i efic\u00e0cia.<\/span><\/li>\n<\/ul>\n

    Qu\u00e8 \u00e9s la biodistribuci\u00f3? Qu\u00e8 \u00e9s l’eliminaci\u00f3 (shedding)? <\/strong><\/h2>\n

    Els estudis de biodistribuci\u00f3 <\/strong>consisteixen en l’avaluaci\u00f3 de la dispersi\u00f3 d’un compost o agent terap\u00e8utic<\/strong> (f\u00e0rmac, nanopart\u00edcula, vector viral o ter\u00e0pia cel\u00b7lular) dins del cos i els \u00f2rgans<\/strong> de l’organisme viu despr\u00e9s de la seva administraci\u00f3. L’objectiu de realitzar estudis de biodistribuci\u00f3 \u00e9s determinar si un f\u00e0rmac arriba a l’\u00f2rgan diana i verificar la possible acumulaci\u00f3 en diferents \u00f2rgans i els efectes toxicol\u00f2gics.<\/strong> <\/span><\/p>\n

    Els estudis d’eliminaci\u00f3 (shedding)<\/strong> consideren l’avaluaci\u00f3 de l’ excreci\u00f3 d’un producte o f\u00e0rmac del subjecte despr\u00e9s de la seva administraci\u00f3<\/strong>, principalment a trav\u00e9s de vies d’excreta (fems), vies de secreta (orina, saliva, fluids nasofaringis, etc.) o fins i tot a trav\u00e9s de la pell (p\u00fastules, llagues, ferides). L’objectiu dels estudis d’eliminaci\u00f3 \u00e9s a<\/b>valuar la possibilitat de transmissi\u00f3 del producte de subjectes tractats a no tractats (sans).<\/strong> <\/span><\/p>\n

    Quina \u00e9s la difer\u00e8ncia entre biodistribuci\u00f3 i eliminaci\u00f3 (shedding)?<\/strong><\/h2>\n

    La biodistribuci\u00f3<\/strong> se centra a determinar com s’est\u00e9n un producte des del lloc d’administraci\u00f3 per tot el cos. Mentre que l’ eliminaci\u00f3 (shedding)<\/strong> descriu com el producte s’excreta o s’allibera del cos del pacient, cosa que implica una possible transmissi\u00f3 a la poblaci\u00f3 sana. <\/span><\/p>\n\n\n\n\n\n\n\n\n\n
    <\/th>\nEstudis de biodistribuci\u00f3<\/strong><\/span><\/th>\nEstudis d’eliminaci\u00f3 (shedding)<\/strong><\/span><\/th>\n<\/tr>\n<\/thead>\n
    Objectiu principal<\/span><\/strong><\/td>\nAvaluar la distribuci\u00f3 de l’agent terap\u00e8utic pels \u00f2rgans del cos<\/span><\/td>\nAvaluar l’alliberament\/excreci\u00f3 del producte despr\u00e9s del tractament<\/span><\/td>\n<\/tr>\n
    Preocupaci\u00f3 principal<\/span><\/strong><\/td>\nDireccionament, persist\u00e8ncia, seguretat<\/span><\/td>\nRisc de transmissi\u00f3<\/span><\/td>\n<\/tr>\n
    Mostres t\u00edpiques<\/span><\/strong><\/td>\nDiferents \u00f2rgans, sang\/plasma<\/span><\/td>\nMostres d’excreci\u00f3: orina, fems, saliva<\/span><\/td>\n<\/tr>\n
    Productes comuns<\/span><\/strong><\/td>\nATMP, vectors virals, virus o bacteris oncol\u00edtics i nanopart\u00edcules<\/span><\/td>\nTer\u00e0pies g\u00e8niques basades en virus o bacteris (vectors virals, virus oncol\u00edtics o bacteris)<\/span><\/td>\n<\/tr>\n
    Enfocament regulador<\/span><\/strong><\/td>\nDistribuci\u00f3 en teixits diana i no diana<\/span><\/td>\nSeguretat ambiental i del pacient<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    <\/h2>\n

    Quan s\u00f3n necessaris els estudis de biodistribuci\u00f3 i d’eliminaci\u00f3 (shedding)?<\/strong><\/h2>\n

    Actualment, els estudis<\/strong> de biodistribuci\u00f3<\/strong> es requereixen no nom\u00e9s per a alguns productes de mol\u00e8cula petita, sin\u00f3 tamb\u00e9 per al camp en constant creixement de les ter\u00e0pies de modalitat avan\u00e7ada i nova, convertint-se en un pas crucial en els estudis precl\u00ednics i de toxicologia<\/em><\/strong> per avaluar la seguretat, l’efic\u00e0cia i les vies d’eliminaci\u00f3 d’un tractament.<\/span><\/p>\n

    Les ves\u00edcules extracel\u00b7lulars, les nanopart\u00edcules, els productes de ter\u00e0pia cel\u00b7lular, els productes oncol\u00edtics (virus o bacteris oncol\u00edtics) i els productes de ter\u00e0pia g\u00e8nica basats en virus o bacteris (productes VBGT), inclosos els vectors virals, estan tots subjectes a estudis de biodistribuci\u00f3<\/strong>.<\/span><\/p>\n

    A m\u00e9s, s’han de realitzar estudis<\/strong> d’ eliminaci\u00f3 (shedding)<\/strong> en productes oncol\u00edtics i VBGT, a causa del possible risc de transmissi\u00f3 a poblacions sanes. L’estudi d’eliminaci\u00f3 s’ha de dur a terme durant les etapes de desenvolupament precl\u00ednic i cl\u00ednic<\/em><\/strong>. En el cas d’aquestes \u00faltimes, poden formar part de l’assaig de seguretat o efic\u00e0cia. <\/span><\/p>\n

    Com avaluar la biodistribuci\u00f3 d’un producte?<\/strong><\/h2>\n
      \n
    • T\u00e8cniques d’imatge<\/strong> (In Vivo i Ex Vivo):<\/span>\n
        \n
      • Imatge nuclear (PET\/SPECT<\/strong>) d’agents marcats<\/span><\/li>\n
      • Imatge \u00f2ptica (fluoresc\u00e8ncia\/bioluminesc\u00e8ncia<\/strong>)<\/span><\/li>\n
      • Imatge per resson\u00e0ncia magn\u00e8tica (MRI<\/strong>) i tomografia computada (CT<\/strong>) per a agents marcats<\/span><\/li>\n<\/ul>\n<\/li>\n
      • M\u00e8todes moleculars i anal\u00edtics<\/strong>:<\/span>\n
          \n
        • M\u00e8todes basats en PCR (qPCR, ddPCR<\/strong>)<\/span><\/li>\n
        • Comptatge de centelleig l\u00edquid (LSC<\/strong>)<\/span><\/li>\n
        • Histologia\/Microsc\u00f2pia<\/span><\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

          Quina \u00e9s la difer\u00e8ncia entre els estudis de biodistribuci\u00f3 i els de<\/strong> farmacocin\u00e8tica (PK)?<\/strong><\/h2>\n

          Els estudis de farmacocin\u00e8tica (PK)<\/strong> avaluen la interacci\u00f3 i el metabolisme del f\u00e0rmac en el cos, se centren a determinar la concentraci\u00f3 del f\u00e0rmac a la sang dels individus en diferents moments durant un per\u00edode de temps. Mentre que la biodistribuci\u00f3<\/strong> determina la pres\u00e8ncia i distribuci\u00f3 de l’agent o compost terap\u00e8utic per tot el cos i en \u00f2rgans o teixits espec\u00edfics. <\/span><\/p>\n

          Quina normativa regula la determinaci\u00f3 de la biodistribuci\u00f3 i l’eliminaci\u00f3 (shedding)?<\/strong><\/h2>\n

          Diverses ag\u00e8ncies reguladores internacionals proporcionen guies sobre l’avaluaci\u00f3 de la biodistribuci\u00f3 i l’eliminaci\u00f3 per a ter\u00e0pies g\u00e8niques, ATMP i altres modalitats terap\u00e8utiques avan\u00e7ades.<\/span><\/p>\n

            \n
          • ICH S12: Consideracions de biodistribuci\u00f3 no cl\u00ednica per a productes de ter\u00e0pia g\u00e8nica<\/em> (esborrany publicat el juny de 2021): <\/strong>proporciona recomanacions harmonitzades per al disseny d’estudis de BD no cl\u00ednics per detectar el producte i la seva expressi\u00f3 en teixits diana i no diana.<\/span><\/span><\/span><\/span><\/li>\n
          • Ag\u00e8ncia Europea de Medicaments (EMA)<\/strong>
            <\/span>\n<\/p>\n
              \n
            • Guia sobre requisits de qualitat, no cl\u00ednics i cl\u00ednics per a medicaments de ter\u00e0pia avan\u00e7ada (ATMP) en investigaci\u00f3: <\/strong>requereix dades sobre la persist\u00e8ncia, la durada de l’efecte i els \u00f2rgans diana.<\/span><\/li>\n
            • Guia sobre els estudis no cl\u00ednics requerits abans del primer \u00fas cl\u00ednic de medicaments de ter\u00e0pia g\u00e8nica: <\/strong>proporciona requisits espec\u00edfics i detallats per als estudis d’eliminaci\u00f3 (p. ex., en excreta, secreta).<\/span><\/span><\/li>\n<\/ul>\n<\/li>\n
            • Administraci\u00f3 d’Aliments i Medicaments dels EUA (FDA). <\/strong><\/span><\/li>\n<\/ul>\n
                \n
              • \n
                  \n
                • Disseny i an\u00e0lisi d’estudis d’eliminaci\u00f3 (shedding) per a ter\u00e0pia g\u00e8nica basada en virus o bacteris i productes oncol\u00edtics (agost de 2015): <\/strong>aquesta \u00e9s la guia principal per avaluar l’alliberament de productes dels pacients.<\/span><\/li>\n
                • Avaluaci\u00f3 precl\u00ednica de productes de ter\u00e0pia cel\u00b7lular i g\u00e8nica en investigaci\u00f3 (2013): <\/strong>aborda la biodistribuci\u00f3 en fase inicial.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
                    \n
                  • L’\u00fas de m\u00e8todes validats o qualificats:<\/strong><\/span><\/span>\n
                      \n
                    • Els m\u00e8todes validats s’utilitzen principalment quan es quantifica l’agent terap\u00e8utic en teixits diana.<\/span><\/li>\n
                    • Els m\u00e8todes qualificats s\u00f3n adequats quan es quantifica l’agent terap\u00e8utic amb finalitats de seguretat i an\u00e0lisi de teixits no diana.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                      On realitzar estudis de biodistribuci\u00f3 i d’eliminaci\u00f3 (shedding)? Com pot ajudar Kymos Group? <\/strong><\/h2>\n
                        \n
                      • Kymos Group t\u00e9 experi\u00e8ncia en estudis de biodistribuci\u00f3 i d’eliminaci\u00f3 (shedding)<\/strong> amb virus oncol\u00edtics i vectors virals (AAV, virus de l’herpes).<\/span>\n
                          \n
                        • Desenvolupament, validaci\u00f3 o qualificaci\u00f3 de m\u00e8todes anal\u00edtics<\/span><\/li>\n<\/ul>\n<\/li>\n
                        • Kymos Group t\u00e9 experi\u00e8ncia en l’expressi\u00f3 g\u00e8nica en teixits diana<\/span><\/strong>\n
                            \n
                          • Desenvolupament, validaci\u00f3 o qualificaci\u00f3 de m\u00e8todes anal\u00edtics<\/span><\/li>\n<\/ul>\n<\/li>\n
                          • Solucions integrals (One-Stop-Shop)<\/strong>
                            Proporcionem als nostres clients assist\u00e8ncia completa en els seus projectes. La nostra soluci\u00f3 fusiona: <\/span><\/li>\n<\/ul>\n
                              \n
                            • \n
                                \n
                              • CRO precl\u00ednica per a l’allotjament i tractament d’animals<\/span><\/li>\n
                              • Estudis histol\u00f2gics<\/span><\/li>\n
                              • Determinaci\u00f3 de la biodistribuci\u00f3 i l’eliminaci\u00f3 (shedding) en diferents matrius biol\u00f2giques<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                Conclusi\u00f3<\/h2>\n

                                El desenvolupament de medicaments de ter\u00e0pia avan\u00e7ada (ATMP) i ter\u00e0pies de nova modalitat \u00e9s un camp que experimenta una expansi\u00f3 considerable.<\/strong> L’\u00fas de vectors terap\u00e8utics complexos, c\u00e8l\u00b7lules vives i organismes planteja la necessitat d’estudiar no nom\u00e9s la seva efic\u00e0cia sin\u00f3 tamb\u00e9 la seguretat tant per als pacients com per a la poblaci\u00f3 en general. En aquest context, els estudis de biodistribuci\u00f3 i d’eliminaci\u00f3 (shedding)<\/strong> s’estan convertint en una fita del desenvolupament precl\u00ednic i cl\u00ednic.<\/strong> Disposar de m\u00e8todes anal\u00edtics robustos i executar assajos reeixits i fiables \u00e9s essencial per a una transici\u00f3 r\u00e0pida de la innovaci\u00f3 de laboratori a la disponibilitat al mercat global. <\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":39998,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95],"tags":[],"class_list":["post-40008","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi"],"acf":[],"yoast_head":"\nEstudis de biodistribuci\u00f3 i eliminaci\u00f3 (shedding): preguntes freq\u00fcents pr\u00e0ctiques<\/title>\n<meta name=\"description\" content=\"Descobriu les difer\u00e8ncies entre els estudis de biodistribuci\u00f3 i d'eliminaci\u00f3 (shedding), quan s\u00f3n necessaris per als ATMP i les ter\u00e0pies g\u00e8niques, i quines consideracions anal\u00edtiques i reguladores s'apliquen.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/ca\/news\/estudis-de-biodistribucio-i-eliminacio-shedding-per-a-atmp-i-terapies-geniques-preguntes-frequents-practiques\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Estudis de biodistribuci\u00f3 i eliminaci\u00f3 (shedding): preguntes freq\u00fcents pr\u00e0ctiques\" \/>\n<meta property=\"og:description\" content=\"Descobriu les difer\u00e8ncies entre els estudis de biodistribuci\u00f3 i d'eliminaci\u00f3 (shedding), quan s\u00f3n 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