{"id":22760,"date":"2019-12-10T11:07:09","date_gmt":"2019-12-10T10:07:09","guid":{"rendered":"https:\/\/kymos.com\/news\/la-dra-lluisa-garcia-assessora-sobre-com-gestionar-les-impureses-de-n-nitrosamina-en-els-sartans\/"},"modified":"2019-12-10T11:07:09","modified_gmt":"2019-12-10T10:07:09","slug":"la-dra-lluisa-garcia-assessora-sobre-com-gestionar-les-impureses-de-n-nitrosamina-en-els-sartans","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/la-dra-lluisa-garcia-assessora-sobre-com-gestionar-les-impureses-de-n-nitrosamina-en-els-sartans\/","title":{"rendered":"La Dra. Llu\u00efsa Garcia assessora sobre com gestionar les impureses de N-nitrosamina en els sartans"},"content":{"rendered":"

“Afronteu la incertesa de la nitrosamina amb una CRO anal\u00edtica flexible i una avaluaci\u00f3 completa del risc”<\/em><\/span><\/h3>\n
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Dr Llu\u00efsa Garc\u00eda, Kymos Pharma Services<\/strong><\/span><\/p>\n

Hi ha hagut molta atenci\u00f3 al voltant del descobriment d’impureses de N-nitrosamina en medicaments per a la pressi\u00f3 arterial coneguts com a sartans. Expliquem com ha sorgit aquesta situaci\u00f3 i entrevistem la nostra experta, la Dra. Llu\u00efsa Garc\u00eda, doctora en qu\u00edmica org\u00e0nica, cofundadora i directora d’operacions de KYMOS, sobre les preocupacions actuals i com abordar-les. <\/span><\/p>\n

\u00abEns enfrontem a un repte mundial, per\u00f2 KYMOS t\u00e9 un historial de desenvolupament de nous m\u00e8todes anal\u00edtics, unitats de servei i fins i tot departaments sencers per abordar les necessitats sobtades i inesperades del mercat biofarmac\u00e8utic\u00bb,<\/em> comen\u00e7a el Dr. Garc\u00eda. \u00abLa nostra feina com a CRO \u00e9s mantenir-nos al dia i, afortunadament, tenim 20 anys d’experi\u00e8ncia interna amb an\u00e0lisis LC-MS\/MS amb font APCI i HS-GC\/MS, ambdues recomanades per l’EMA i la FDA per a la quantificaci\u00f3 de nitrosamines\u00bb.<\/em> <\/span><\/p>\n

Antecedents de les impureses de N-nitrosamina<\/strong><\/span>
\nEl juny de 2018 es van detectar diverses impureses de N-nitrosamina en medicaments per a la pressi\u00f3 arterial coneguts com a “sartans”. M\u00e9s recentment, tamb\u00e9 s’han trobat impureses de N-nitrosamina en lots de ranitidina, un producte utilitzat per tractar les \u00falceres d’est\u00f3mac, aix\u00ed com en altres subst\u00e0ncies farmacol\u00f2giques. Les N-nitrosamines podrien representar un risc greu per a la nostra salut, ja que estan classificades com a potencialment cancer\u00edgenes per als humans. Amb l’aparici\u00f3 creixent de noves nitrosamines en diferents productes farmacol\u00f2gics, l’EMA va sol\u00b7licitar el setembre passat que totes les companyies farmac\u00e8utiques realitzessin avaluacions de riscos per determinar quines impureses de nitrosamines s\u00f3n m\u00e9s propenses a apar\u00e8ixer en els seus productes farmacol\u00f2gics i subst\u00e0ncies actives (API) fabricats i que despr\u00e9s avaluessin experimentalment la seva abs\u00e8ncia en tots els productes en risc. <\/span><\/p>\n

\u00abAquest \u00e9s un problema molt complex per m\u00faltiples motius\u00bb, afirma el Dr. Garc\u00eda. \u00abPer comen\u00e7ar, els requisits reglamentaris afecten tots els medicaments humans que contenen ingredients actius actius (API) sintetitzats qu\u00edmicament, amb la seva varietat intr\u00ednseca, vies de s\u00edntesi complexes, fonts potencials d’impureses de nitrosamines (inclosos excipients i dissolvents) i din\u00e0miques de contaminaci\u00f3 creuada. Per\u00f2 a m\u00e9s d’aix\u00f2, les autoritats de la UE han demanat que el resultat de les avaluacions de riscos es publiqui abans del mar\u00e7 del 2020. Les empreses tindran llavors fins a 3 anys per adaptar tots els seus r\u00e8gims de fabricaci\u00f3 i proves per garantir, en \u00faltima inst\u00e0ncia, que els seus productes no tinguin nivells quantificables de nitrosamines\u00bb.< 0,03 ppm) abans que es puguin utilitzar a la UE. Com us dir\u00e0 qualsevol qu\u00edmic org\u00e0nic, aix\u00f2 \u00e9s molt per aconseguir en molt poc temps.\u201d <\/em><\/span><\/p>\n

Gesti\u00f3 de les impureses de N-nitrosamina <\/strong><\/span>
\n\u00abEls nostres clients globals s’adrecen a KYMOS amb necessitats variables\u00bb,<\/em> comenta la Dra. Garc\u00eda. \u00abDes de sol\u00b7licituds per a proves d’impureses espec\u00edfiques de N-nitrosamina, en particular API, fins a projectes de cribratge m\u00e9s ambiciosos per a la detecci\u00f3 de desenes de nitrosamines diferents en una \u00e0mplia gamma de medicaments comercialitzats. Alguns dels nostres clients semblen seguir la mateixa estrat\u00e8gia del 2017, quan l’EMA va publicar la guia ICH Q3D per limitar els metalls en productes farmac\u00e8utics\u00bb,<\/em> recorda Llu\u00efsa. \u00abEn aquell moment, KYMOS va estar a l’altura del repte, incorporant nous instruments ICP\/MS al que ara \u00e9s la nostra divisi\u00f3 d’impureses elementals. Fa dos anys nom\u00e9s hav\u00edem de tractar una llista de 24 impureses met\u00e0l\u00b7liques ben caracteritzades. Ara la llista de nitrosamines \u00e9s molt m\u00e9s llarga i t\u00e9 l\u00edmits menys clars, de manera que un m\u00e8tode general potser mai no ser\u00e0 prou inclusiu\u00bb,<\/em> afirma. <\/span><\/p>\n

\u00abLa clau per a una estrat\u00e8gia reeixida de N-nitrosamines \u00e9s identificar les possibles nitrosamines amb una avaluaci\u00f3 de riscos completa, com les que ofereixen socis com AZIERTA<\/a> , i combinar-la amb un enfocament anal\u00edtic flexible: si no esteu segurs del resultat de la vostra reavaluaci\u00f3, recolzeu-vos en una CRO amb prou experi\u00e8ncia per adaptar r\u00e0pidament els m\u00e8todes de detecci\u00f3 a noves subst\u00e0ncies i impureses.\u00bb<\/em><\/span><\/p>\n

Qu\u00e8 t\u00e9 d’especial la detecci\u00f3 d’impureses de N-nitrosamina?<\/strong><\/span>
\nKYMOS t\u00e9 anys d’experi\u00e8ncia en el desenvolupament i validaci\u00f3 de m\u00e8todes altament sensibles i espec\u00edfics per a la detecci\u00f3 d’impureses, complementats amb instruments LC-MS\/MS i HS-GC\/MS d’\u00faltima generaci\u00f3, tant als nostres laboratoris de bioan\u00e0lisi de Barcelona com a la nostra filial italiana Pharmaprogress.<\/span><\/p>\n

\u00abTenir dos centres separats i completament equipats i els coneixements necessaris per caracteritzar tot tipus de subst\u00e0ncies, des de vol\u00e0tils fins a impureses genot\u00f2xiques, ens d\u00f3na la capacitat d’afrontar projectes complexos en un temps r\u00e8cord\u00bb,<\/em> explica el Dr. Garc\u00eda.<\/span><\/p>\n

Com pot ajudar KYMOS?<\/strong><\/span>
\nLes directrius actuals per evitar la contaminaci\u00f3 per N-nitrosamina en medicaments humans combinen l’avaluaci\u00f3 inicial del risc amb proves confirmat\u00f2ries addicionals dels productes farmac\u00e8utics i els API identificats com a en risc de formaci\u00f3 de N-nitrosamina. KYMOS proposa dos enfocaments alternatius per a aquest pas confirmatori: ampli o espec\u00edfic. <\/span><\/p>\n

\u00abAlguns clients demanen el desenvolupament i la validaci\u00f3 de m\u00e8todes espec\u00edfics per a les nitrosamines identificades per l’avaluaci\u00f3 de riscos\u00bb,<\/em> comen\u00e7a el Dr. Garc\u00eda, \u00abmentre que d’altres prefereixen una detecci\u00f3 m\u00e9s general de les nitrosamines m\u00e9s comunes abans d’una quantificaci\u00f3 m\u00e9s detallada. Els nostres m\u00e8todes actuals comprenen de 7 a 12 N-nitrosamines i impliquen dues t\u00e8cniques anal\u00edtiques diferents segons cada cas, per\u00f2 sempre complint amb els l\u00edmits reglamentaris de quantificaci\u00f3, que en dos anys estaran restringits per sota de 0,03 ppm\u00bb.<\/em> <\/span><\/p>\n

El futur de les N-nitrosamines<\/strong><\/span>
\nQuan se li pregunta sobre el futur de la detecci\u00f3 de nitrosamines en medicaments humans, el Dr. Garc\u00eda confia que el pic de c\u00e0rrega de treball encara est\u00e0 per arribar.<\/span><\/p>\n

\u00abHi ha un malestar innegable entre els nostres clients, per\u00f2 molts d’ells tot just comencen a preparar les seves avaluacions de riscos\u00bb,<\/em> sost\u00e9.<\/span><\/p>\n

“Com que totes les avaluacions s’han de concloure i presentar com a molt tard el 26 de mar\u00e7 de 2020, \u00e9s for\u00e7a probable que la primavera vinent marqui el principal augment de la demanda, per\u00f2 at\u00e8s el termini ajustat, un per\u00edode de gr\u00e0cia no est\u00e0 descartat.” <\/em><\/span><\/p>\n

Tornant a l’experi\u00e8ncia pr\u00e8via de KYMOS amb impureses elementals, el Dr. Garc\u00eda preveu una evoluci\u00f3 similar.<\/span><\/p>\n

\u00abUn cop les autoritats sanit\u00e0ries rebin les primeres avaluacions de risc dels titulars de l’autoritzaci\u00f3 de comercialitzaci\u00f3, haur\u00edem d’esperar directrius m\u00e9s clares pel que fa als productes en risc, les possibles fonts de contaminaci\u00f3 per nitrosamines i les mesures de precauci\u00f3 recomanades. La guia ICH Q3D sobre impureses elementals tamb\u00e9 va desencadenar un auge de l’activitat, per\u00f2 dos anys m\u00e9s tard la situaci\u00f3 s’ha estabilitzat clarament. Es podria argumentar que les N-nitrosamines s\u00f3n molt m\u00e9s dif\u00edcils i de gran abast que les impureses met\u00e0l\u00b7liques i, per tant, la situaci\u00f3 pot durar m\u00e9s temps.\u00bb <\/em><\/span><\/p>\n

En aquest punt, el Dr. Garc\u00eda conclou amb una reflexi\u00f3 reconfortant:<\/span><\/p>\n

\u201cUna cosa est\u00e0 clara. A KYMOS tenim una \u00e0mplia experi\u00e8ncia interna amb la metodologia anal\u00edtica pertinent, estem completament equipats amb equips LC-MS\/MS i HS-GC\/MS d’\u00faltima generaci\u00f3 i, el m\u00e9s important, som competents en la validaci\u00f3 i el desenvolupament des de zero de m\u00e8todes de detecci\u00f3 d’impureses. Aix\u00ed doncs, independentment del que ens depari el futur, estem segurs que, juntament amb els nostres clients fidels, superarem la tempesta de nitrosamines.\u201d<\/em><\/span><\/p>\n

Podeu trobar m\u00e9s informaci\u00f3 sobre els serveis de proves de N-nitrosamina<\/a> al nostre lloc web.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

“Afronteu la incertesa de la nitrosamina amb una CRO anal\u00edtica […]<\/p>\n","protected":false},"author":6,"featured_media":15015,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95,97],"tags":[],"class_list":["post-22760","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","category-cmc-ca"],"acf":[],"yoast_head":"\nPerspectivesCom gestionar les impureses de N-nitrosamina en els sartans<\/title>\n<meta name=\"description\" content=\"Descobriment d'impureses de N-nitrosamina en medicaments per a la pressi\u00f3 arterial coneguts com a sartans. La Dra. 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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? 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\/ca\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22760","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/comments?post=22760"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/posts\/22760\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media\/15015"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/media?parent=22760"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/categories?post=22760"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/ca\/wp-json\/wp\/v2\/tags?post=22760"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}