{"id":27114,"date":"2018-05-18T12:13:20","date_gmt":"2018-05-18T10:13:20","guid":{"rendered":"https:\/\/kymos.com\/news\/essai-de-puissance-vaccinale\/"},"modified":"2025-12-03T18:58:03","modified_gmt":"2025-12-03T17:58:03","slug":"essai-de-puissance-vaccinale","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/essai-de-puissance-vaccinale\/","title":{"rendered":"Essai de puissance vaccinale"},"content":{"rendered":"

Les vaccins sont des produits biologiques destin\u00e9s \u00e0 administrer des antig\u00e8nes afin d’induire une r\u00e9ponse immunitaire et une m\u00e9moire immunitaire contre une maladie particuli\u00e8re. Ils peuvent \u00eatre prophylactiques ou th\u00e9rapeutiques et g\u00e9n\u00e9rer une immunit\u00e9 par r\u00e9ponse humorale ou cellulaire. <\/span><\/p>\n

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La fabrication des vaccins est une activit\u00e9 complexe, car le r\u00e9sultat de ce processus peut varier en fonction de nombreux facteurs, notamment la mutabilit\u00e9 du micro-organisme ou de l’antig\u00e8ne biologique au fil du temps, les mati\u00e8res premi\u00e8res, l’environnement, le proc\u00e9d\u00e9 de purification ou les adjuvants utilis\u00e9s. N\u00e9anmoins, le profil de tous les lots destin\u00e9s \u00e0 la commercialisation doit rester constant et les entreprises pharmaceutiques doivent mettre en \u0153uvre des contr\u00f4les qualit\u00e9 rigoureux. <\/span><\/p>\n

Historiquement, le contr\u00f4le qualit\u00e9 des vaccins s’effectuait en testant l’efficacit\u00e9 du produit final sur des animaux de diff\u00e9rentes esp\u00e8ces. Aujourd’hui, face au d\u00e9veloppement de nouveaux vaccins et \u00e0 la mise \u00e0 jour des vaccins existants, les entreprises ont recours \u00e0 des essais biologiques in vitro pour \u00e9valuer leur efficacit\u00e9. <\/span><\/p>\n

Validation de la m\u00e9thode<\/span><\/h3>\n

Les vaccins vivants n\u00e9cessitent g\u00e9n\u00e9ralement des tests cellulaires, qui utilisent un syst\u00e8me cellulaire sp\u00e9cifique pour d\u00e9montrer une r\u00e9ponse biologique mesurable. En revanche, les vaccins sous-unitaires, les vaccins anatoxiques, les vaccins conjugu\u00e9s et les vaccins contre les allergies peuvent \u00eatre suivis de mani\u00e8re fiable par des immunoessais. <\/span><\/p>\n

Un obstacle majeur r\u00e9side dans la validation du test d’analyse qui, conform\u00e9ment \u00e0 la norme ICH Q2 (R1), doit permettre de quantifier la fraction active dans les \u00e9chantillons. Les exigences des BPF relatives \u00e0 la validation du test sont l’exactitude, la pr\u00e9cision, la r\u00e9p\u00e9tabilit\u00e9, la pr\u00e9cision interm\u00e9diaire, la sp\u00e9cificit\u00e9, la limite de d\u00e9tection, la lin\u00e9arit\u00e9 et l’\u00e9tendue de la gamme. <\/span><\/p>\n

De nos jours, les entreprises pharmaceutiques, tant humaines que v\u00e9t\u00e9rinaires, d\u00e9veloppent des tests de contr\u00f4le qualit\u00e9 de l’activit\u00e9 des nouveaux vaccins presque exclusivement par des tests in vitro. Pour les produits existants, bien que le remplacement des tests in vivo pour la lib\u00e9ration des lots<\/strong><\/a> de vaccins puisse s’av\u00e9rer complexe, il pr\u00e9sente de nombreux avantages : am\u00e9lioration de la reproductibilit\u00e9 des m\u00e9thodes, simplification du transfert de m\u00e9thodes entre diff\u00e9rents laboratoires, r\u00e9duction du nombre d’animaux utilis\u00e9s pour l’exp\u00e9rimentation, acc\u00e9l\u00e9ration des d\u00e9lais de production et diminution des co\u00fbts. <\/span><\/p>\n

Pour en savoir plus sur nos services de d\u00e9veloppement et de validation de m\u00e9thodes<\/a> , cliquez ici.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":27115,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267],"tags":[],"class_list":["post-27114","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nTest de puissance vaccinale\u00a0: garantir l\u2019efficacit\u00e9 de l\u2019immunisation<\/title>\n<meta name=\"description\" content=\"Apprenez-en davantage sur les tests d'activit\u00e9 vaccinale et les services de Kymos en mati\u00e8re de d\u00e9veloppement et de validation de m\u00e9thodes. 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