{"id":27640,"date":"2021-09-28T12:45:01","date_gmt":"2021-09-28T10:45:01","guid":{"rendered":"https:\/\/kymos.com\/news\/experience-directe-de-pharmaprogress-avec-les-nitrosamines-repousser-les-limites-de-lanalyse\/"},"modified":"2025-12-03T19:01:23","modified_gmt":"2025-12-03T18:01:23","slug":"experience-directe-de-pharmaprogress-avec-les-nitrosamines-repousser-les-limites-de-lanalyse","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/experience-directe-de-pharmaprogress-avec-les-nitrosamines-repousser-les-limites-de-lanalyse\/","title":{"rendered":"Exp\u00e9rience directe de Pharmaprogress avec les nitrosamines&nbsp;: repousser les limites de l\u2019analyse"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container 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-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>Nous avons le plaisir d&rsquo;annoncer que le Dr Luca Gramaccioni, directeur g\u00e9n\u00e9ral du site italien <a href=\"https:\/\/kymos.com\/fr\/pharmaprogress\/\" data-wpel-link=\"internal\">de Pharmaprogress<\/a> \u00e0 Kymos, a \u00e9t\u00e9 invit\u00e9 \u00e0 partager son expertise analytique sur les nitrosamines lors d&rsquo;un nouveau webinaire \u2013 cette fois-ci \u00e0 l&rsquo;occasion du Symposium AFI 2021 organis\u00e9 par l&rsquo;Associazione Farmaceutici Industria le 24 septembre. En amont de cet \u00e9v\u00e9nement, le Dr Gramaccioni et le Dr Massimo Bartolacci, expert en nitrosamines chez Pharmaprogress, partageront leurs analyses sur l&rsquo;\u00e9volution des exigences r\u00e9glementaires depuis le classement des nitrosamines comme canc\u00e9rog\u00e8nes probables pour l&rsquo;homme en 2019. <\/p>\n<p>\u00ab Au d\u00e9part, les autorit\u00e9s ont fix\u00e9 la limite de concentration de 0,03 ppm pour chaque nitrosamine comme seuil permettant de d\u00e9montrer l&rsquo;absence de nitrosamine, et cette limite est donc devenue l&rsquo;objet de toutes les attentions \u00bb, explique le Dr Bartolacci. \u00ab Cependant, avec le temps, l&rsquo;obligation de lier la limite de sp\u00e9cification pour les nitrosamines \u00e0 la DDM (dose journali\u00e8re maximale) du principe actif est devenue imp\u00e9rative, ce qui a entra\u00een\u00e9 une diff\u00e9renciation des limites de sp\u00e9cification et a n\u00e9cessit\u00e9 leur r\u00e9duction globale. \u00bb  <\/p>\n<p>De plus, selon les directives actuelles, si les fabricants peuvent prouver que la teneur en nitrosamines ne d\u00e9passe pas 10 % des limites sp\u00e9cifi\u00e9es, ils sont exempt\u00e9s des analyses de routine des nitrosamines dans le cadre de leur contr\u00f4le qualit\u00e9 en production. \u00c0 ce stade, les travaux sur les principes actifs pharmaceutiques (API) sont termin\u00e9s ou presque, et les entreprises passent \u00e0 la deuxi\u00e8me \u00e9tape du dosage des nitrosamines. Cette \u00e9tape est ax\u00e9e sur le projet finalis\u00e9 et, surtout, requiert des m\u00e9thodes analytiques plus sensibles. Heureusement, l&rsquo;\u00e9quipe du Dr Bartolacci \u00e9tait \u00e0 la hauteur du d\u00e9fi.  <\/p>\n<p>\u00ab Nous avons r\u00e9cemment mis au point une m\u00e9thode avec une limite inf\u00e9rieure de 0,1 ppb, un nouveau record interne qui t\u00e9moigne de notre engagement \u00e0 repousser sans cesse les limites \u00bb, d\u00e9clare le Dr Bartolacci. \u00ab Cette capacit\u00e9 d&rsquo;adaptation aux seuils de d\u00e9tection les plus bas, conjugu\u00e9e \u00e0 notre vaste exp\u00e9rience dans le domaine des nitrosamines et \u00e0 nos installations performantes, dot\u00e9es d&rsquo;instruments LC-MS\/MS et HS-GC-MS d\u00e9di\u00e9s \u00e0 l&rsquo;analyse des nitrosamines, nous a permis de nous adapter \u00e0 l&rsquo;\u00e9volution des exigences r\u00e9glementaires et analytiques et, en d\u00e9finitive, de satisfaire les besoins de nos clients avec la m\u00eame qualit\u00e9 et la m\u00eame r\u00e9activit\u00e9 qu&rsquo;ils attendent de nous \u00bb, conclut le Dr Bartolacci.<\/p>\n<p>Il n&rsquo;est donc pas surprenant que l&rsquo;\u00e9quipe de Pharmaprogress ait \u00e9t\u00e9 invit\u00e9e \u00e0 participer au symposium AFI 2021. La conf\u00e9rence du Dr Luca Gramaccioni, intitul\u00e9e \u00ab&nbsp;Exp\u00e9rience pratique face aux d\u00e9fis analytiques du dosage des nitrosamines&nbsp;\u00bb, s&rsquo;inscrira dans le cadre du webinaire \u00ab&nbsp;Nitrosamines&nbsp;: o\u00f9 en sommes-nous&nbsp;?&nbsp;\u00bb. <\/p>\n<p>Pour <strong><a href=\"https:\/\/newaurameeting.it\/prodotto\/live-webinar-simposio-afi-sessione-affari-regolatori\/\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">plus d&rsquo;informations sur le webinaire, cliquez ici<\/a><\/strong> . Les inscriptions seront possibles jusqu&rsquo;\u00e0 17h la veille du webinaire. L&rsquo;inscription est gratuite pour les membres de l&rsquo;AFI et le personnel de l&rsquo;AIFA, de l&rsquo;Institut sup\u00e9rieur de la sant\u00e9 et du minist\u00e8re de la Sant\u00e9. Les frais d&rsquo;inscription pour les non-membres de l&rsquo;AFI sont de 50 \u20ac HT (TVA \u00e0 22 %).  <\/p>\n<p>Apprenez-en davantage sur nos <a href=\"https:\/\/kymos.com\/fr\/services\/analyse-cmc-et-controle-qualite\/elements-nitrosamines-et-autres-impuretes\/\" data-wpel-link=\"internal\"><b>tests d&rsquo;\u00e9l\u00e9ments, de nitrosamines et d&rsquo;autres impuret\u00e9s<\/b><\/a> , ainsi que sur notre <strong><a href=\"https:\/\/kymos.com\/fr\/services\/analyse-cmc-et-controle-qualite\/controle-de-la-qualite-des-petites-molecules\/\" data-wpel-link=\"internal\">contr\u00f4le de la qualit\u00e9 des petites mol\u00e9cules<\/a><\/strong> et <strong><a href=\"https:\/\/kymos.com\/fr\/services\/analyse-cmc-et-controle-qualite\/controle-de-la-qualite-des-produits-biologiques-et-biosimilaires\/\" data-wpel-link=\"internal\">des produits biologiques et biosimilaires<\/a><\/strong> .<\/p>\n<p><a href=\"https:\/\/kymos.com\/fr\/contact\/\" data-wpel-link=\"internal\">Contactez-nous<\/a> ou envoyez-nous un courriel \u00e0 <strong><a href=\"mailto:commercial@kymos.com?subject=Nouveaux%20instruments%20chez%20Kymos\" data-wpel-link=\"internal\">commercial@kymos.com<\/a><\/strong> .<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27644,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[260],"tags":[62],"class_list":["post-27640","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-groupe-kymos","tag-joan"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tests de nitrosamines chez Pharmaprogress<\/title>\n<meta name=\"description\" content=\"Dr Luca Gramaccioni, responsable du site Pharmaprogress\u00a0: 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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&amp;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? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.\",\"url\":\"https:\\\/\\\/kymos.com\\\/fr\\\/news\\\/author\\\/joan-puig-de-dou\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Tests de nitrosamines chez Pharmaprogress","description":"Dr Luca Gramaccioni, responsable du site Pharmaprogress\u00a0: Exp\u00e9rience pratique avec les nitrosamines\u00a0: repousser les limites de l\u2019analyse","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/kymos.com\/fr\/news\/experience-directe-de-pharmaprogress-avec-les-nitrosamines-repousser-les-limites-de-lanalyse\/","og_locale":"fr_FR","og_type":"article","og_title":"Tests de nitrosamines chez Pharmaprogress","og_description":"Dr Luca Gramaccioni, responsable du site Pharmaprogress\u00a0: 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Dou","image":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","caption":"Joan Puig de Dou"},"description":"Active in the pharmaceutical marketing for over 30 years President of CataloniaBIO&amp;HealthTech CEO and Qualified Person at Kymos Leader of Kymos team, guaranteeing a trustable, ethical and scientific correct editorial publications. 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&amp;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? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.","url":"https:\/\/kymos.com\/fr\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts\/27640","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/comments?post=27640"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts\/27640\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/media\/27644"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/media?parent=27640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/categories?post=27640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/tags?post=27640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}