{"id":3262,"date":"2024-03-06T06:06:03","date_gmt":"2024-03-06T06:06:03","guid":{"rendered":"https:\/\/longchangextracts.com\/?p=2970"},"modified":"2024-03-06T06:06:03","modified_gmt":"2024-03-06T06:06:03","slug":"__trashed-2","status":"publish","type":"post","link":"https:\/\/longchangextracts.com\/fr\/__trashed-2\/","title":{"rendered":"Comment un processus de fabrication en flux continu efficace peut-il \u00eatre appliqu\u00e9 aux produits biopharmaceutiques ?"},"content":{"rendered":"

Comment un processus de fabrication en flux continu efficace peut-il \u00eatre appliqu\u00e9 aux produits biopharmaceutiques ?<\/strong><\/h1>\n

Recherche et d\u00e9veloppement sur la formation de cristaux de m\u00e9dicaments<\/p>\n

Actuellement, l'industrie biopharmaceutique conna\u00eet une croissance rapide, notamment en raison de l'augmentation de l'expression en amont et de la mise \u00e0 l'\u00e9chelle. La production conventionnelle par lots est d'une efficacit\u00e9 limit\u00e9e, tandis que la production en flux continu pr\u00e9sente des applications prometteuses en termes d'augmentation de la capacit\u00e9, de r\u00e9duction des co\u00fbts et de r\u00e9duction des d\u00e9lais.<\/p>\n

Contexte<\/p>\n

L'industrie biopharmaceutique chinoise vient de d\u00e9marrer et les soci\u00e9t\u00e9s pharmaceutiques chinoises ont un grand \u00e9cart avec les g\u00e9ants biopharmaceutiques \u00e9trangers en termes de niveau technologique, d'\u00e9chelle de production et d'efficacit\u00e9. Si elles continuent \u00e0 suivre le mode de production par lots des m\u00e9dicaments d'origine \u00e9trang\u00e8re, elles n'auront aucun avantage en termes de co\u00fbts de production et seront dans une position d\u00e9savantageuse lors de l'appel d'offres pour l'achat de bandes. Par cons\u00e9quent, pour gagner dans cette concurrence f\u00e9roce, les entreprises biopharmaceutiques chinoises doivent disposer d'un meilleur processus de production, d'une plus grande efficacit\u00e9 de production et de co\u00fbts de production inf\u00e9rieurs \u00e0 ceux des fabricants de m\u00e9dicaments d'origine. L'application de la technologie de production en continu constituera une perc\u00e9e qui permettra aux entreprises biopharmaceutiques chinoises d'acqu\u00e9rir un avantage concurrentiel. La technologie de production en continu vient de d\u00e9marrer, et les entreprises nationales et \u00e9trang\u00e8res en sont \u00e0 peu pr\u00e8s au m\u00eame point de d\u00e9part. Si les entreprises biosimilaires chinoises peuvent saisir l'occasion de donner la priorit\u00e9 au d\u00e9veloppement et \u00e0 l'utilisation de la technologie de production continue, elles pourront profiter de l'avantage du retardataire en am\u00e9liorant l'efficacit\u00e9 de la production et en r\u00e9duisant les co\u00fbts de production.<\/p>\n

La production traditionnelle de produits biologiques utilise un processus de production par lots, qui n\u00e9cessite une s\u00e9rie d'intervalles entre les \u00e9tapes de production. Chaque intervalle dans l'ensemble du processus entra\u00eene une r\u00e9duction et un retard dans l'efficacit\u00e9 de la production et augmente la probabilit\u00e9 de d\u00e9fauts du produit et d'erreurs op\u00e9rationnelles. La technologie pharmaceutique de production en continu est une technologie \u00e9mergente qui doit encore faire face \u00e0 de nombreux probl\u00e8mes r\u00e9glementaires et d\u00e9fis technologiques, mais la sup\u00e9riorit\u00e9 de la production en continu est \u00e9vidente et constitue une tendance g\u00e9n\u00e9rale dans le d\u00e9veloppement des processus biopharmaceutiques, qui peut am\u00e9liorer la robustesse et la fiabilit\u00e9 du processus de production, r\u00e9duire les d\u00e9penses de production et d'immobilisations, r\u00e9duire le temps de construction de l'usine et r\u00e9duire le temps n\u00e9cessaire pour le changement de produit dans la production.<\/p>\n

Dans le processus de production en aval, la mise en \u0153uvre du flux continu passe principalement par l'utilisation de la chromatographie en flux continu, des tests en ligne et d'autres technologies pour int\u00e9grer plusieurs unit\u00e9s de traitement (figure 1), ce qui peut am\u00e9liorer l'efficacit\u00e9 de la production et l'utilisation de l'usine tout en r\u00e9duisant le stockage interm\u00e9diaire, le temps d'attente entre les \u00e9tapes et l'\u00e9chelle de l'instrumentation et des intrants correspondants, afin d'atteindre l'objectif de raccourcir la dur\u00e9e du cycle et de r\u00e9duire le co\u00fbt de la production. L'objectif est de raccourcir le cycle de production et de r\u00e9duire les co\u00fbts de production.<\/p>\n

\"\"<\/p>\n

\u00c9tude de cas<\/p>\n

En ce qui concerne le processus de purification en aval, il consiste principalement en ce qui suit : la premi\u00e8re \u00e9tape consiste \u00e0 capturer l'anticorps avec un milieu d'affinit\u00e9 pour la prot\u00e9ine A ; la deuxi\u00e8me \u00e9tape utilise la chromatographie cationique comme purification interm\u00e9diaire pour \u00e9liminer les polym\u00e8res de l'anticorps, le HCP, l'ADN, etc. ; et la troisi\u00e8me \u00e9tape utilise un milieu de chromatographie anionique pour s\u00e9parer finement l'ADN r\u00e9siduel, le HCP, la prot\u00e9ine A, l'endotoxine, etc. afin d'atteindre l'objectif de la purification (figure 2). La troisi\u00e8me \u00e9tape consiste \u00e0 s\u00e9parer finement l'ADN r\u00e9siduel, le HCP, la prot\u00e9ine A, l'endotoxine et d'autres impuret\u00e9s \u00e0 l'aide d'un milieu de chromatographie anionique afin de r\u00e9aliser la purification (figure 2).<\/p>\n

\"\"<\/p>\n

L'objectif principal du processus de purification en aval est d'augmenter la puret\u00e9 et le rendement du produit par la s\u00e9paration et la purification, et de garantir la qualit\u00e9 et la stabilit\u00e9 du produit. La production continue n\u00e9cessite de relier toutes les \u00e9tapes afin que le processus de production soit hautement int\u00e9gr\u00e9 et automatis\u00e9, et de garantir la stabilit\u00e9 et la coh\u00e9rence du produit, etc. (figure 3).<\/p>\n

\"\"<\/p>\n

Le processus de flux continu peut am\u00e9liorer l'utilisation des remplisseuses, r\u00e9duire la dur\u00e9e du processus et augmenter la capacit\u00e9 (figure 4). L'application du processus de flux continu sera d\u00e9crite dans plusieurs \u00e9tudes de cas ci-dessous.<\/p>\n

\"\"<\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

Comment un processus de fabrication en flux continu efficace peut-il \u00eatre appliqu\u00e9 aux produits biopharmaceutiques ? Formation de cristaux de m\u00e9dicaments Recherche et d\u00e9veloppement L'industrie biopharmaceutique conna\u00eet actuellement une croissance rapide, notamment en raison de l'augmentation de l'expression en amont et de la mise \u00e0 l'\u00e9chelle. La production conventionnelle par lots est d'une efficacit\u00e9 limit\u00e9e, tandis que la production en flux continu pr\u00e9sente des applications prometteuses en termes d'augmentation de la capacit\u00e9, de r\u00e9duction des co\u00fbts [...]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"yoast_head":"\nHow can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? - China Chemical Manufacturer<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/longchangextracts.com\/fr\/__trashed-2\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? - China Chemical Manufacturer\" \/>\n<meta property=\"og:description\" content=\"How can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? 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