{"id":27380,"date":"2020-05-30T11:01:22","date_gmt":"2020-05-30T09:01:22","guid":{"rendered":"https:\/\/kymos.com\/news\/analyse-des-impuretes-elementaires-anticiper-les-besoins-de-nos-clients-avant-meme-quils-ne-les-expriment\/"},"modified":"2025-12-03T18:59:52","modified_gmt":"2025-12-03T17:59:52","slug":"analyse-des-impuretes-elementaires-anticiper-les-besoins-de-nos-clients-avant-meme-quils-ne-les-expriment","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/analyse-des-impuretes-elementaires-anticiper-les-besoins-de-nos-clients-avant-meme-quils-ne-les-expriment\/","title":{"rendered":"Analyse des impuret\u00e9s \u00e9l\u00e9mentaires : anticiper les besoins de nos clients avant m\u00eame qu\u2019ils ne les expriment."},"content":{"rendered":"

La Pharmacop\u00e9e europ\u00e9enne a transpos\u00e9 la directive ICH Q3D en juin 2017, imposant la recherche d’impuret\u00e9s \u00e9l\u00e9mentaires potentielles dans tous les m\u00e9dicaments. Cette directive sera d\u00e9sormais \u00e9tendue aux produits \u00e0 usage v\u00e9t\u00e9rinaire. <\/span><\/h3>\n
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Nous nous entretenons avec notre experte en impuret\u00e9s \u00e9l\u00e9mentaires<\/a> , Gemma Solsona, qui nous fait part des derni\u00e8res \u00e9volutions du secteur. Forte de pr\u00e8s de dix ans d’exp\u00e9rience dans l’industrie pharmaceutique, Gemma dirige un d\u00e9partement historiquement li\u00e9 aux changements r\u00e9glementaires. <\/span><\/p>\n

\u00ab Pour faire face aux changements \u00e0 venir, la recommandation g\u00e9n\u00e9rale est de se pr\u00e9parer \u00e0 l\u2019avance \u00bb,<\/em> dit-elle.<\/span><\/p>\n

Comment KYMOS s’est-il pr\u00e9par\u00e9 \u00e0 cette \u00e9valuation ?<\/strong><\/span>
\nEn 2017 et 2018, la demande d’analyses de m\u00e9dicaments par les entreprises a fortement augment\u00e9, co\u00efncidant avec la mise en \u0153uvre des directives ICH Q3D relatives aux impuret\u00e9s \u00e9l\u00e9mentaires dans les produits pharmaceutiques. Gemma et son \u00e9quipe poss\u00e8dent une vaste exp\u00e9rience avec plus de 600 produits diff\u00e9rents. Elles ont r\u00e9alis\u00e9 des analyses approfondies gr\u00e2ce \u00e0 la spectrom\u00e9trie de masse \u00e0 plasma \u00e0 couplage inductif (ICP-MS), une technique de pointe permettant des limites de d\u00e9tection plus basses et des analyses multi-\u00e9l\u00e9mentaires simultan\u00e9es, ainsi qu’\u00e0 la spectrom\u00e9trie d’absorption atomique (AAS). Cette riche exp\u00e9rience a permis \u00e0 KYMOS de d\u00e9velopper un d\u00e9partement sp\u00e9cialis\u00e9 dans les impuret\u00e9s \u00e9l\u00e9mentaires. <\/span><\/p>\n

\u00ab Nous avons mis au point une m\u00e9thode interne de contr\u00f4le des impuret\u00e9s \u00e9l\u00e9mentaires qui nous permet de nous adapter rapidement au produit du client, ce qui se traduit par une analyse rapide et abordable \u00bb,<\/em> explique Gemma.<\/span><\/p>\n

Comment Gemma et son \u00e9quipe peuvent-elles vous aider ?<\/strong><\/span>
\nL’\u00e9quipe de Gemma est parfaitement pr\u00e9par\u00e9e \u00e0 apporter des solutions \u00e0 trois nouveaux d\u00e9fis :<\/span><\/p>\n

    \n
  1. \u00c0 la mi-2019, il a \u00e9t\u00e9 d\u00e9cid\u00e9 d’\u00e9tendre le champ d’application de l’ICH Q3D aux m\u00e9dicaments v\u00e9t\u00e9rinaires. Si l’expertise de KYMOS repose sur l’analyse de m\u00e9dicaments \u00e0 usage humain, elle est parfaitement transposable au secteur v\u00e9t\u00e9rinaire ; le service est donc d\u00e9j\u00e0 propos\u00e9. <\/span><\/li>\n
  2. KYMOS propose \u00e9galement un nouveau service valid\u00e9, bas\u00e9 sur la m\u00e9thode de la pharmacop\u00e9e relative \u00e0 l’eau purifi\u00e9e (04\/2018:0008), r\u00e9cemment mise en \u0153uvre pour le contr\u00f4le des impuret\u00e9s \u00e9l\u00e9mentaires dans l’eau couramment utilis\u00e9e lors de la fabrication de la grande majorit\u00e9 des produits (formulations liquides ou autres). Cette m\u00e9thode enti\u00e8rement valid\u00e9e permet au client de s’affranchir de l’\u00e9tape de validation, co\u00fbteuse et chronophage, et ainsi de b\u00e9n\u00e9ficier d’une offre plus comp\u00e9titive. <\/span><\/li>\n
  3. KYMOS d\u00e9veloppe une m\u00e9thode ICP-MS interne pour remplacer les m\u00e9thodes colorim\u00e9triques de la pharmacop\u00e9e telles que la d\u00e9termination de l’arsenic.<\/span><\/li>\n<\/ol>\n

    \u00ab Nous disposons de techniques de pointe et, en respectant les derni\u00e8res r\u00e9glementations, nous sommes en mesure d’anticiper les besoins de nos clients \u00bb,<\/em> ajoute Gemma.<\/span><\/p>\n

    Alors, quelle est la prochaine \u00e9tape pour Gemma et son ambitieux d\u00e9partement ? <\/strong><\/span>
    \n\u00ab Ce service est dynamique et anim\u00e9 par une forte volont\u00e9 d’am\u00e9lioration continue. \u00bb<\/em> Gemma et son \u00e9quipe s’efforcent de r\u00e9duire leurs d\u00e9lais : \u00ab Nous sommes en mesure de fournir un rapport de pr\u00e9s\u00e9lection sous 2 \u00e0 3 semaines et les r\u00e9sultats pour le contr\u00f4le qualit\u00e9 sous 5 \u00e0 10 jours. \u00bb<\/em><\/span><\/p>\n

    Les prochaines ann\u00e9es seront cruciales, car l’\u00e9quipe de Gemma poursuit la mise en \u0153uvre de m\u00e9thodes de test compl\u00e8tes et l’\u00e9laboration de nouvelles normes conformes aux exigences relatives aux m\u00e9dicaments \u00e0 usage humain. Au vu des r\u00e9sultats obtenus jusqu’\u00e0 pr\u00e9sent, nous sommes convaincus que Gemma et son \u00e9quipe m\u00e8neront \u00e0 bien cette mission avec efficacit\u00e9 et professionnalisme. <\/span><\/p>\n

    <\/span><\/p>\n

    Vous pouvez consulter plus d’informations sur KYMOS, les services g\u00e9n\u00e9raux d’\u00e9limination des impuret\u00e9s \u00e9l\u00e9mentaires<\/a> et l’eau purifi\u00e9e<\/a> ou nous contacter \u00e0 l’ adresse commercial@kymos.com<\/a> .<\/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":6,"featured_media":27382,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267],"tags":[],"class_list":["post-27380","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nAnalyse des impuret\u00e9s \u00e9l\u00e9mentaires - Kymos<\/title>\n<meta name=\"description\" content=\"CRO pour l'analyse des impuret\u00e9s \u00e9l\u00e9mentaires. 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Experience Joan Puig de Dou started his career at Laboratorios Menarini first as scientist later as Qualified Person and finally as Operations General Manager. 2010 he entered Kymos where he became CEO in 2015. 2022 Joan Puig de Dou was elected as president of CataloniaBio&HealthTech to represent the Catalonian biotech industry nationally and internationally. Expertise Joan Puig de Dou has extensive experience in writing scientific content adopting a didactic approach that fits any reader\u2019s level of expertise. He publishes regularely on Kymos\u2019 webpage, social media and in the specialized press. Education He graduated from Universitat de Barcelona as Pharmacist and from IESE Business School\u2019s Programa Diecci\u00f3n General (PDG) Want to know him better? 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