La demande croissante pour un suivi instantan\u00e9 des proc\u00e9d\u00e9s et une fabrication plus constante des m\u00e9dicaments biologiques devrait stimuler les investissements dans les technologies d\u2019analyse des processus, appel\u00e9es PAT. Selon un rapport publi\u00e9 par MarketsandMarkets le 28 juillet, le march\u00e9 mondial de ces technologies pourrait atteindre 4,32 milliards de dollars d\u2019ici 2031. Cette progression refl\u00e8te l\u2019adoption accrue de syst\u00e8mes analytiques permettant aux fabricants de mesurer et de r\u00e9guler les \u00e9tapes de production en direct. Ces outils aident \u00e0 d\u00e9tecter plus t\u00f4t les \u00e9carts dans les proc\u00e9d\u00e9s et \u00e0 mieux contr\u00f4ler les param\u00e8tres critiques, un avantage essentiel alors que la production de m\u00e9dicaments biologiques s\u2019\u00e9tend.<\/p>\n
Un autre rapport, celui d\u2019IQVIA publi\u00e9 en f\u00e9vrier, pr\u00e9voit que les d\u00e9penses mondiales en traitements contre le cancer, une discipline tr\u00e8s li\u00e9e aux m\u00e9dicaments biologiques, augmenteront d\u2019environ 9 % par an entre 2026 et 2030, pour atteindre environ 250 milliards de dollars \u00e0 la fin de la d\u00e9cennie. Dans ce contexte, ma\u00eetriser les variations des mati\u00e8res premi\u00e8res, des cultures cellulaires et des \u00e9tapes de purification sera crucial pour garantir la qualit\u00e9 et la r\u00e9gularit\u00e9 des lots.<\/p>\n
Les fabricants s\u2019orientent de plus en plus vers des m\u00e9thodes comme la qualit\u00e9 d\u00e8s la conception, l\u2019automatisation et la fabrication continue. Int\u00e9grer des mesures analytiques directement dans la production permet de limiter les tests r\u00e9trospectifs sur les produits finis, mais cela exige des m\u00e9thodes valid\u00e9es, des syst\u00e8mes de gestion des donn\u00e9es robustes et une strat\u00e9gie de contr\u00f4le adapt\u00e9e.<\/p>\n
En Europe, les PAT prennent aussi leur sens avec l\u2019application des lignes directrices de l\u2019ICH sur la fabrication continue. L\u2019Agence europ\u00e9enne du m\u00e9dicament (EMA) a notamment publi\u00e9 la directive ICH Q13, qui encadre le d\u00e9veloppement, le fonctionnement et la gestion du cycle de vie des proc\u00e9d\u00e9s continus. Quand ces technologies s\u2019appuient sur une compr\u00e9hension approfondie des processus et une strat\u00e9gie de contr\u00f4le justifi\u00e9e scientifiquement, elles peuvent aussi faciliter les tests de lib\u00e9ration en temps r\u00e9el.<\/p>\n
Ces syst\u00e8mes fournissent des donn\u00e9es rapides sur la production, permettant de confirmer que le proc\u00e9d\u00e9 reste ma\u00eetris\u00e9. Cependant, pour en tirer pleinement profit, les fabricants devront valider leurs m\u00e9thodes, s\u00e9curiser l\u2019int\u00e9grit\u00e9 des donn\u00e9es et se conformer aux exigences r\u00e9glementaires.<\/p>\n","protected":false},"excerpt":{"rendered":"
La demande croissante pour un suivi instantan\u00e9 des proc\u00e9d\u00e9s et une fabrication plus constante des m\u00e9dicaments biologiques devrait stimuler les […]<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[414],"tags":[],"class_list":["post-423","post","type-post","status-publish","format-standard","hentry","category-nouvelles"],"_links":{"self":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/423","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/comments?post=423"}],"version-history":[{"count":1,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/423\/revisions"}],"predecessor-version":[{"id":434,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/423\/revisions\/434"}],"wp:attachment":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/media?parent=423"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/categories?post=423"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/tags?post=423"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}