{"id":6533,"date":"2022-08-25T11:30:00","date_gmt":"2022-08-25T11:30:00","guid":{"rendered":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/"},"modified":"2022-08-25T11:30:00","modified_gmt":"2022-08-25T11:30:00","slug":"nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen","status":"publish","type":"mfn_news","link":"https:\/\/nanexa.com\/sv\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/","title":{"rendered":"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen"},"content":{"rendered":"
\n

Nanexa AB (publ) meddelar idag att bolagets nybyggda pilotanl\u00e4ggning i Uppsala erh\u00e5llit certifiering fr\u00e5n L\u00e4kemedelsverket f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial.<\/strong><\/p>\n<\/div>\n

\n

Nanexa har sedan tidigare GMP-certifikat f\u00f6r tillverkning och frisl\u00e4ppning av kliniskt pr\u00f6vningsl\u00e4kemedel i liten skala. Den nya, st\u00f6rre anl\u00e4ggningen \u00e4r utformad f\u00f6r mer storskalig och effektivare tillverkning och \u00e4ven f\u00f6r att s\u00e5v\u00e4l toxiska som biologiska l\u00e4kemedel ska kunna tillverkas med Atomic Layer Deposition-teknologin.<\/p>\n

L\u00e4kemedelsverket genomf\u00f6rde i juni en inspektion av Nanexas nya pilotanl\u00e4ggning i Uppsala och uppdaterade kvalitetssystem f\u00f6r att utf\u00e4rda certifikat f\u00f6r tillverkning och frisl\u00e4ppning av kliniskt pr\u00f6vningsmaterial. Inspektionen gjordes utan st\u00f6rre anm\u00e4rkningar och efter att bolaget besvarat och hanterat ett antal utest\u00e5ende fr\u00e5gor erh\u00f6lls idag slutligt godk\u00e4nnande och certifikat.<\/p>\n

\u201dDet \u00e4r mycket gl\u00e4djande att v\u00e5rt h\u00e5rda arbete med f\u00e4rdigst\u00e4llandet och kvalitetss\u00e4kring av pilotanl\u00e4ggningen och fortsatt GMP-regelefterlevnad g\u00e5tt s\u00e5 bra och i linje med den tidsplan vi satt upp. Certifieringen inneb\u00e4r att vi nu har \u00e4nnu b\u00e4ttre m\u00f6jligheter att producera pr\u00f6vningsmaterial f\u00f6r kliniska studier och n\u00e4rmast ligger v\u00e5rt eget projekt NEX-20, d\u00e4r vi planerar att starta en fas I-studie under fj\u00e4rde kvartalet i \u00e5r\u201d, s\u00e4ger David Westberg, vd f\u00f6r Nanexa. \u201dAtt vi nu har GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen och ett komplett kvalitetssystem \u00e4r ytterligare ett steg fram\u00e5t f\u00f6r att ta flera projekt in i klinisk utveckling och mycket viktigt i v\u00e5ra diskussioner med potentiella partners om kommande projekt\u201d. <\/p>\n<\/div>\n

\n

F\u00f6r mer information kontakta:<\/strong><\/p>\n

\n

David Westberg \u2013 VD, Nanexa AB (publ)\u00a0
Telefon: 0709-42 83 03
E-post:\u00a0david.westberg@nanexa.se<\/a>
www.nanexa.com<\/a><\/p>\n

Erik Penser Bank \u00e4r bolagets Certified Adviser och n\u00e5s p\u00e5 08-463 83 00, e-post: certifiedadviser@penser.se<\/p>\n<\/div>\n

\n

Om Nanexa AB (publ)<\/strong><\/p>\n

\n

Nanexa \u00e4r ett l\u00e4kemedelsbolag som utvecklar parenterala l\u00e4kemedel baserade p\u00e5 det patenterade och innovativa drug delivery-systemet PharmaShell\u00ae \u2013 ett system som m\u00f6jligg\u00f6r n\u00e4sta generations l\u00e5ngverkande injicerbara l\u00e4kemedel med h\u00f6g drug load, tillverkade med atomlagerprecision. Nanexa utvecklar egna produkter och har dessutom samarbetsavtal med flera l\u00e4kemedelsbolag, d\u00e4ribland AstraZeneca.<\/p>\n

Nanexas aktie \u00e4r noterad p\u00e5 Nasdaq First North Growth Market i Stockholm (NANEXA).<\/p>\n<\/div>\n

\n

Bifogade filer<\/strong><\/p>\n

\n

Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Nanexa AB (publ) meddelar idag att bolagets nybyggda pilotanl\u00e4ggning i Uppsala erh\u00e5llit certifiering fr\u00e5n L\u00e4kemedelsverket f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial.<\/p>\n","protected":false},"template":"","class_list":["post-6533","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci_sv","mfn-news-tag-mfn-type-ir_sv","mfn-news-tag-mfn_sv","mfn-news-tag-mfn-ci-other_sv","mfn-news-tag-mfn-lang-sv_sv"],"acf":[],"yoast_head":"\nNanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen - Nanexa AB<\/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:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen - Nanexa AB\" \/>\n<meta property=\"og:description\" content=\"Nanexa AB (publ) meddelar idag att bolagets nybyggda pilotanl\u00e4ggning i Uppsala erh\u00e5llit certifiering fr\u00e5n L\u00e4kemedelsverket f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/\" \/>\n<meta property=\"og:site_name\" content=\"Nanexa AB\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minuter\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nanexa.com\\\/mfn_news\\\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\\\/\",\"url\":\"https:\\\/\\\/nanexa.com\\\/mfn_news\\\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\\\/\",\"name\":\"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen - Nanexa AB\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nanexa.com\\\/#website\"},\"datePublished\":\"2022-08-25T11:30:00+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/nanexa.com\\\/mfn_news\\\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\\\/#breadcrumb\"},\"inLanguage\":\"sv-SE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/nanexa.com\\\/mfn_news\\\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/nanexa.com\\\/mfn_news\\\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Hem\",\"item\":\"https:\\\/\\\/nanexa.com\\\/sv\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MFN News Items\",\"item\":\"https:\\\/\\\/nanexa.com\\\/mfn_news\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/nanexa.com\\\/#website\",\"url\":\"https:\\\/\\\/nanexa.com\\\/\",\"name\":\"Nanexa AB\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/nanexa.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/nanexa.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"sv-SE\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/nanexa.com\\\/#organization\",\"name\":\"Nanexa AB\",\"url\":\"https:\\\/\\\/nanexa.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"sv-SE\",\"@id\":\"https:\\\/\\\/nanexa.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/nanexa.com\\\/wp-content\\\/uploads\\\/2015\\\/04\\\/nanexa-logo.png\",\"contentUrl\":\"https:\\\/\\\/nanexa.com\\\/wp-content\\\/uploads\\\/2015\\\/04\\\/nanexa-logo.png\",\"width\":165,\"height\":50,\"caption\":\"Nanexa AB\"},\"image\":{\"@id\":\"https:\\\/\\\/nanexa.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen - Nanexa AB","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:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/","og_locale":"sv_SE","og_type":"article","og_title":"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen - Nanexa AB","og_description":"Nanexa AB (publ) meddelar idag att bolagets nybyggda pilotanl\u00e4ggning i Uppsala erh\u00e5llit certifiering fr\u00e5n L\u00e4kemedelsverket f\u00f6r tillverkning av kliniskt pr\u00f6vningsmaterial.","og_url":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/","og_site_name":"Nanexa AB","twitter_card":"summary_large_image","twitter_misc":{"Ber\u00e4knad l\u00e4stid":"2 minuter"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/","url":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/","name":"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen - Nanexa AB","isPartOf":{"@id":"https:\/\/nanexa.com\/#website"},"datePublished":"2022-08-25T11:30:00+00:00","breadcrumb":{"@id":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/#breadcrumb"},"inLanguage":"sv-SE","potentialAction":[{"@type":"ReadAction","target":["https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-utokat-gmp-certifikat-for-den-nya-pilotanlaggningen\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Hem","item":"https:\/\/nanexa.com\/sv\/"},{"@type":"ListItem","position":2,"name":"MFN News Items","item":"https:\/\/nanexa.com\/mfn_news\/"},{"@type":"ListItem","position":3,"name":"Nanexa erh\u00e5ller ut\u00f6kat GMP certifikat f\u00f6r den nya pilotanl\u00e4ggningen"}]},{"@type":"WebSite","@id":"https:\/\/nanexa.com\/#website","url":"https:\/\/nanexa.com\/","name":"Nanexa AB","description":"","publisher":{"@id":"https:\/\/nanexa.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/nanexa.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"sv-SE"},{"@type":"Organization","@id":"https:\/\/nanexa.com\/#organization","name":"Nanexa AB","url":"https:\/\/nanexa.com\/","logo":{"@type":"ImageObject","inLanguage":"sv-SE","@id":"https:\/\/nanexa.com\/#\/schema\/logo\/image\/","url":"https:\/\/nanexa.com\/wp-content\/uploads\/2015\/04\/nanexa-logo.png","contentUrl":"https:\/\/nanexa.com\/wp-content\/uploads\/2015\/04\/nanexa-logo.png","width":165,"height":50,"caption":"Nanexa AB"},"image":{"@id":"https:\/\/nanexa.com\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/nanexa.com\/sv\/wp-json\/wp\/v2\/mfn_news\/6533","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nanexa.com\/sv\/wp-json\/wp\/v2\/mfn_news"}],"about":[{"href":"https:\/\/nanexa.com\/sv\/wp-json\/wp\/v2\/types\/mfn_news"}],"wp:attachment":[{"href":"https:\/\/nanexa.com\/sv\/wp-json\/wp\/v2\/media?parent=6533"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}