{"id":40028,"date":"2026-05-25T13:54:17","date_gmt":"2026-05-25T11:54:17","guid":{"rendered":"https:\/\/kymos.com\/news\/etudes-de-biodistribution-et-dexcretion-pour-les-mti-et-les-therapies-geniques-faq-pratique\/"},"modified":"2026-05-25T14:09:11","modified_gmt":"2026-05-25T12:09:11","slug":"etudes-de-biodistribution-et-dexcretion-pour-les-mti-et-les-therapies-geniques-faq-pratique","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/etudes-de-biodistribution-et-dexcretion-pour-les-mti-et-les-therapies-geniques-faq-pratique\/","title":{"rendered":"\u00c9tudes de biodistribution et d\u2019excr\u00e9tion pour les MTI et les th\u00e9rapies g\u00e9niques : FAQ pratique"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background 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-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:20px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\">Les m\u00e9dicaments de th\u00e9rapie innovante (MTI), les vecteurs viraux et d\u2019autres modalit\u00e9s th\u00e9rapeutiques \u00e9mergentes transforment le d\u00e9veloppement des m\u00e9dicaments. \u00c0 mesure que ces th\u00e9rapies deviennent plus complexes,<strong> comprendre comment elles se distribuent dans l\u2019organisme et si elles peuvent \u00eatre lib\u00e9r\u00e9es dans l\u2019environnement devient essentiel<\/strong> tant pour la conformit\u00e9 r\u00e9glementaire que pour la s\u00e9curit\u00e9 des patients. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Les \u00e9tudes de biodistribution et d\u2019excr\u00e9tion jouent un r\u00f4le essentiel tout au long du d\u00e9veloppement pr\u00e9clinique et clinique.<\/strong> Cette vue d\u2019ensemble au format FAQ explique leur objectif, leurs diff\u00e9rences, les attentes r\u00e9glementaires et les approches analytiques couramment utilis\u00e9es pour \u00e9tayer ces \u00e9tudes.<\/span><\/p>\n<h2>Points cl\u00e9s \u00e0 retenir<\/h2>\n<ul>\n<li><span style=\"font-size: 14pt;\">Les \u00e9tudes de biodistribution \u00e9valuent <strong>la mani\u00e8re dont les produits th\u00e9rapeutiques se distribuent dans l\u2019organisme.<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Les \u00e9tudes d\u2019excr\u00e9tion <strong>\u00e9valuent si un produit peut \u00eatre lib\u00e9r\u00e9 par des individus trait\u00e9s<\/strong>.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Ces \u00e9tudes sont<strong> particuli\u00e8rement importantes pour les MTI, les th\u00e9rapies \u00e0 base de virus ou de bact\u00e9ries<\/strong>.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Les agences r\u00e9glementaires, dont la <strong>FDA, l\u2019EMA et l\u2019ICH, fournissent des recommandations pour l\u2019\u00e9valuation de la biodistribution et de l\u2019excr\u00e9tion.<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Des m\u00e9thodes analytiques robustes sont indispensables<\/strong> pour \u00e9tayer les \u00e9valuations de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9.<\/span><\/li>\n<\/ul>\n<h2><strong>Qu\u2019est-ce que la biodistribution ? Qu\u2019est-ce que l\u2019excr\u00e9tion ? <\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Les <strong>\u00e9tudes de biodistribution <\/strong>consistent \u00e0 \u00e9valuer la <strong>dispersion d\u2019un compos\u00e9 ou d\u2019un agent th\u00e9rapeutique<\/strong> (m\u00e9dicament, nanoparticule, vecteur viral ou th\u00e9rapie cellulaire) <strong>dans l\u2019organisme et les organes<\/strong> d\u2019un organisme vivant apr\u00e8s son administration. L\u2019objectif des \u00e9tudes de biodistribution est de <strong>d\u00e9terminer si un m\u00e9dicament atteint l\u2019organe cible et de v\u00e9rifier une \u00e9ventuelle accumulation dans diff\u00e9rents organes ainsi que des effets toxicologiques.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Les <strong>\u00e9tudes d\u2019excr\u00e9tion<\/strong> portent sur l\u2019\u00e9valuation de l\u2019<strong>excr\u00e9tion d\u2019un produit ou d\u2019un m\u00e9dicament par le sujet apr\u00e8s son administration<\/strong>, principalement via les voies d\u2019excr\u00e9tion (selles), les voies de s\u00e9cr\u00e9tion (urine, salive, liquides nasopharyng\u00e9s, etc.) ou encore via la peau (pustules, l\u00e9sions, plaies). L\u2019objectif des \u00e9tudes d\u2019excr\u00e9tion est d\u2019<b>\u00e9<\/b><strong>valuer la possibilit\u00e9 de transmission du produit de sujets trait\u00e9s \u00e0 des sujets non trait\u00e9s (sains).<\/strong> <\/span><\/p>\n<h2><strong>Quelle est la diff\u00e9rence entre la biodistribution et l\u2019excr\u00e9tion ?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">La <strong>biodistribution<\/strong> vise \u00e0 d\u00e9terminer comment un produit se propage depuis le site d\u2019administration dans l\u2019organisme. Alors que l\u2019<strong>excr\u00e9tion<\/strong> d\u00e9crit comment le produit est excr\u00e9t\u00e9 ou lib\u00e9r\u00e9 par l\u2019organisme du patient, impliquant une possible transmission \u00e0 la population saine. <\/span><\/p>\n<table style=\"height: 616px; width: 100%;\">\n<thead>\n<tr style=\"height: 56px;\">\n<th style=\"width: 26.253%; height: 56px;\"><\/th>\n<th style=\"width: 36.2768%; height: 56px; text-align: left;\"><span style=\"font-size: 14pt;\"><strong>\u00c9tudes de biodistribution<\/strong><\/span><\/th>\n<th style=\"width: 35.0835%; height: 56px; text-align: left;\"><span style=\"font-size: 14pt;\"><strong>\u00c9tudes d\u2019excr\u00e9tion<\/strong><\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr style=\"height: 140px;\">\n<td style=\"width: 26.253%; height: 140px;\"><strong><span style=\"font-size: 14pt;\">Objectif principal<\/span><\/strong><\/td>\n<td style=\"width: 36.2768%; height: 140px;\"><span style=\"font-size: 14pt;\">\u00c9valuer la distribution de l\u2019agent th\u00e9rapeutique dans les organes de l\u2019organisme<\/span><\/td>\n<td style=\"width: 35.0835%; height: 140px;\"><span style=\"font-size: 14pt;\">\u00c9valuer la lib\u00e9ration\/l\u2019excr\u00e9tion du produit apr\u00e8s le traitement<\/span><\/td>\n<\/tr>\n<tr style=\"height: 84px;\">\n<td style=\"width: 26.253%; height: 84px;\"><strong><span style=\"font-size: 14pt;\">Pr\u00e9occupation principale<\/span><\/strong><\/td>\n<td style=\"width: 36.2768%; height: 84px;\"><span style=\"font-size: 14pt;\">Ciblage, persistance, s\u00e9curit\u00e9<\/span><\/td>\n<td style=\"width: 35.0835%; height: 84px;\"><span style=\"font-size: 14pt;\">Risque de transmission<\/span><\/td>\n<\/tr>\n<tr style=\"height: 84px;\">\n<td style=\"width: 26.253%; height: 84px;\"><strong><span style=\"font-size: 14pt;\">\u00c9chantillons typiques<\/span><\/strong><\/td>\n<td style=\"width: 36.2768%; height: 84px;\"><span style=\"font-size: 14pt;\">Diff\u00e9rents organes, sang\/plasma<\/span><\/td>\n<td style=\"width: 35.0835%; height: 84px;\"><span style=\"font-size: 14pt;\">\u00c9chantillons d\u2019excr\u00e9tion : urine, selles, salive<\/span><\/td>\n<\/tr>\n<tr style=\"height: 168px;\">\n<td style=\"width: 26.253%; height: 168px;\"><strong><span style=\"font-size: 14pt;\">Produits courants<\/span><\/strong><\/td>\n<td style=\"width: 36.2768%; height: 168px;\"><span style=\"font-size: 14pt;\">MTI, vecteurs viraux, virus ou bact\u00e9ries oncolytiques et nanoparticules<\/span><\/td>\n<td style=\"width: 35.0835%; height: 168px;\"><span style=\"font-size: 14pt;\">Th\u00e9rapies g\u00e9niques \u00e0 base de virus ou de bact\u00e9ries (vecteurs viraux, virus oncolytiques ou bact\u00e9ries)<\/span><\/td>\n<\/tr>\n<tr style=\"height: 84px;\">\n<td style=\"width: 26.253%; height: 84px;\"><strong><span style=\"font-size: 14pt;\">Focus r\u00e9glementaire<\/span><\/strong><\/td>\n<td style=\"width: 36.2768%; height: 84px;\"><span style=\"font-size: 14pt;\">Distribution dans les tissus cibles\/non cibles<\/span><\/td>\n<td style=\"width: 35.0835%; height: 84px;\"><span style=\"font-size: 14pt;\">S\u00e9curit\u00e9 environnementale et s\u00e9curit\u00e9 des patients<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><\/h2>\n<h2><strong>Quand les \u00e9tudes de biodistribution et d\u2019excr\u00e9tion sont-elles n\u00e9cessaires ?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Aujourd\u2019hui, les <strong>\u00e9tudes<\/strong> de <strong>biodistribution<\/strong> sont requises non seulement pour certains produits \u00e0 petites mol\u00e9cules, mais aussi pour le domaine en constante expansion des th\u00e9rapies avanc\u00e9es et des nouvelles modalit\u00e9s. Elles sont devenues une \u00e9tape cruciale des \u00e9tudes <strong><em>pr\u00e9cliniques et de toxicologie<\/em><\/strong> afin d\u2019\u00e9valuer la s\u00e9curit\u00e9, l\u2019efficacit\u00e9 et les voies d\u2019\u00e9limination d\u2019un traitement.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Les v\u00e9sicules extracellulaires, les nanoparticules, les produits de th\u00e9rapie cellulaire, les produits oncolytiques (virus ou bact\u00e9ries oncolytiques) et les produits de th\u00e9rapie g\u00e9nique \u00e0 base de virus ou de bact\u00e9ries (produits VBGT), y compris les vecteurs viraux, sont tous soumis \u00e0 des <strong>\u00e9tudes de biodistribution<\/strong>.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En outre, des \u00e9tudes d\u2019<strong>excr\u00e9tion<\/strong> <strong>(shedding)<\/strong> doivent \u00eatre men\u00e9es sur les produits oncolytiques et VBGT, en raison du risque potentiel de transmission \u00e0 des populations saines. L\u2019\u00e9tude d\u2019excr\u00e9tion doit \u00eatre r\u00e9alis\u00e9e aux <strong><em>stades de d\u00e9veloppement pr\u00e9clinique et clinique<\/em><\/strong>. Dans ce dernier cas, elle peut faire partie de l\u2019essai de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9.  <\/span><\/p>\n<h2><strong>Comment \u00e9valuer la biodistribution d\u2019un produit ?<\/strong><\/h2>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Techniques d\u2019imagerie<\/strong> (in vivo &#038; ex vivo) :<\/span>\n<ul>\n<li><span style=\"font-size: 14pt;\">Imagerie nucl\u00e9aire (<strong>TEP\/TEMP<\/strong>) d\u2019agents marqu\u00e9s<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Imagerie optique (<strong>fluorescence\/bioluminescence<\/strong>)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Imagerie par r\u00e9sonance magn\u00e9tique (<strong>IRM<\/strong>) &#038; tomodensitom\u00e9trie (<strong>TDM<\/strong>) pour les agents marqu\u00e9s<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\"><strong>M\u00e9thodes mol\u00e9culaires et analytiques<\/strong> :<\/span>\n<ul>\n<li><span style=\"font-size: 14pt;\">M\u00e9thodes bas\u00e9es sur la PCR (<strong>qPCR, ddPCR<\/strong>)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Comptage par scintillation liquide (<strong>LSC<\/strong>)<\/span><\/li>\n<li><strong><span style=\"font-size: 14pt;\">Histologie\/microscopie<\/span><\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><strong>Quelle est la diff\u00e9rence entre les \u00e9tudes de biodistribution et<\/strong> <strong>de pharmacocin\u00e9tique (PK) ?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Les <strong>\u00e9tudes de pharmacocin\u00e9tique (PK)<\/strong> \u00e9valuent l\u2019interaction et le m\u00e9tabolisme du m\u00e9dicament dans l\u2019organisme ; elles visent \u00e0 d\u00e9terminer la concentration du m\u00e9dicament dans le sang des individus \u00e0 diff\u00e9rents moments sur une p\u00e9riode donn\u00e9e. Alors que la <strong>biodistribution<\/strong> d\u00e9termine la pr\u00e9sence et la distribution de l\u2019agent th\u00e9rapeutique ou du compos\u00e9 dans l\u2019ensemble de l\u2019organisme ainsi que dans des organes ou tissus sp\u00e9cifiques.  <\/span><\/p>\n<h2><strong>Quelle r\u00e9glementation encadre la d\u00e9termination de la biodistribution et de l\u2019excr\u00e9tion ?<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Plusieurs agences r\u00e9glementaires internationales fournissent des recommandations sur l\u2019\u00e9valuation de la biodistribution et de l\u2019excr\u00e9tion pour les th\u00e9rapies g\u00e9niques, les MTI et d\u2019autres modalit\u00e9s th\u00e9rapeutiques avanc\u00e9es.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><span style=\"font-size: 14pt;\"><span style=\"font-size: 14pt;\"><span style=\"font-size: 14pt;\"><strong>ICH S12 : <em>Consid\u00e9rations non cliniques relatives \u00e0 la biodistribution pour les produits de th\u00e9rapie g\u00e9nique<\/em> (projet publi\u00e9 en juin 2021) : <\/strong>fournit des recommandations harmonis\u00e9es pour la conception d\u2019\u00e9tudes non cliniques de BD afin de d\u00e9tecter le produit et son expression dans les tissus cibles\/non cibles.<\/span><\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Agence europ\u00e9enne des m\u00e9dicaments (EMA)<\/strong><br \/><\/span>\n<\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Ligne directrice sur les exigences de qualit\u00e9, non cliniques et cliniques pour les m\u00e9dicaments de th\u00e9rapie innovante (MTI) en investigation : <\/strong>exige des donn\u00e9es sur la persistance, la dur\u00e9e d\u2019effet et les organes cibles.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><span style=\"font-size: 14pt;\"><strong>Ligne directrice sur les \u00e9tudes non cliniques requises avant la premi\u00e8re utilisation clinique des m\u00e9dicaments de th\u00e9rapie g\u00e9nique : <\/strong>fournit des exigences sp\u00e9cifiques et d\u00e9taill\u00e9es pour les \u00e9tudes d\u2019excr\u00e9tion (p. ex., dans les excreta, secreta).<\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Food and Drug Administration (FDA) des \u00c9tats-Unis. <\/strong><\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products (ao\u00fbt 2015) : <\/strong>il s\u2019agit de la principale ligne directrice pour \u00e9valuer la lib\u00e9ration de produits par les patients<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Preclinical Assessment of Investigational Cellular and Gene Therapy Products (2013) : <\/strong>aborde la biodistribution aux stades pr\u00e9coces.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\"><span style=\"font-size: 14pt;\"><strong>Utilisation de m\u00e9thodes valid\u00e9es ou qualifi\u00e9es :<\/strong><\/span><\/span>\n<ul>\n<li><span style=\"font-size: 14pt;\">Les m\u00e9thodes valid\u00e9es sont principalement utilis\u00e9es lors de la quantification de l\u2019agent th\u00e9rapeutique dans les tissus cibles<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Les m\u00e9thodes qualifi\u00e9es conviennent lorsque l\u2019agent th\u00e9rapeutique est quantifi\u00e9 \u00e0 des fins de s\u00e9curit\u00e9 et d\u2019analyse des tissus non cibles.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><strong>O\u00f9 r\u00e9aliser des \u00e9tudes de biodistribution et d\u2019excr\u00e9tion ? Comment Kymos Group peut-il vous accompagner ? <\/strong><\/h2>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>Kymos Group dispose d\u2019une exp\u00e9rience en \u00e9tudes de biodistribution et d\u2019excr\u00e9tion<\/strong> avec des virus oncolytiques et des vecteurs viraux (AAV, virus de l\u2019herp\u00e8s)<\/span>\n<ul>\n<li><span style=\"font-size: 14pt;\">D\u00e9veloppement, validation ou qualification de m\u00e9thodes analytiques<\/span><\/li>\n<\/ul>\n<\/li>\n<li><strong><span style=\"font-size: 14pt;\">Kymos Group dispose d\u2019une exp\u00e9rience en expression g\u00e9nique dans les tissus cibles<\/span><\/strong>\n<ul>\n<li><span style=\"font-size: 14pt;\">D\u00e9veloppement, validation ou qualification de m\u00e9thodes analytiques<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\"><strong>Solutions One-Stop-Shop<\/strong><br \/>Offrir \u00e0 nos clients un accompagnement complet sur leurs projets. Notre solution combine : <\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span style=\"font-size: 14pt;\">CRO pr\u00e9clinique pour l\u2019h\u00e9bergement et le traitement des animaux<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u00c9tudes histologiques<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">D\u00e9termination de la biodistribution et de l\u2019excr\u00e9tion dans diff\u00e9rentes matrices biologiques<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2>Conclusion<\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>Le d\u00e9veloppement des m\u00e9dicaments de th\u00e9rapie innovante (MTI) et des th\u00e9rapies de nouvelles modalit\u00e9s est un domaine en forte expansion.<\/strong> L\u2019utilisation de vecteurs th\u00e9rapeutiques complexes, de cellules vivantes et d\u2019organismes vivants impose d\u2019\u00e9tudier non seulement leur efficacit\u00e9, mais aussi leur s\u00e9curit\u00e9, tant pour les patients que pour la population au sens large. Dans ce contexte, les <strong>\u00e9tudes de biodistribution et d\u2019excr\u00e9tion<\/strong> <strong>deviennent une \u00e9tape cl\u00e9 du d\u00e9veloppement pr\u00e9clinique et clinique.<\/strong> Disposer de m\u00e9thodes analytiques robustes et mener des essais r\u00e9ussis et fiables sont essentiels pour une transition rapide de l\u2019innovation en laboratoire vers une disponibilit\u00e9 sur le march\u00e9 mondial. <\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":39999,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[257],"tags":[],"class_list":["post-40028","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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