{"id":20275,"date":"2023-07-12T11:30:00","date_gmt":"2023-07-12T11:30:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4155382_CN55382_0"},"modified":"2023-07-12T11:30:00","modified_gmt":"2023-07-12T11:30:00","slug":"race-executes-agreement-with-ardena-for-gmp-manufacturing-of-rc220","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=20275","title":{"rendered":"Race executes agreement with Ardena for GMP manufacturing of RC220"},"content":{"rendered":"<ul type=\"disc\">\n<li><b>Race Oncology executes agreement with leading global contract development and manufacturing organisation, Ardena as additional partner for GMP manufacturing of flagship RC220 bistanrene formulation<\/b><\/li>\n<li><b>Ardena has a long track record of providing sterile injectable products for all stages of clinical development<\/b><\/li>\n<li><b>Partnership strengthens the existing manufacturing programs by serving as a primary source for EU compliant supplies required for EU clinical studies, while also providing a backup source for US and Australian clinical programs.<\/b><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SYDNEY<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">July 12, 2023<\/span><\/span> \/PRNewswire\/ &#8212;&nbsp;Race Oncology Limited (&#8220;Race&#8221;) is pleased to announce that it has signed an agreement with leading global contract development and manufacturing&nbsp;organisation (CDMO), Ardena Holding NV (Ardena) to provide additional Good Manufacturing Practice (cGMP)-standard manufacturing capability for Race&#8217;s flagship intravenous (IV) formulation of bisantrene, RC220.<\/p>\n<p>Ardena is a fully integrated CDMO which assists biopharma companies with services spanning the drug development life cycle. The company has a long track record of providing sterile injectable products for all stages of clinical development.<\/p>\n<p>The partnership strengthens Race&#8217;s existing manufacturing programs by serving as a primary source for EU compliant supplies of RC220 required for EU clinical studies. It also provides a backup source for US and Australian clinical programs.<\/p>\n<p><b>CEO and Managing Director, <span class=\"xn-person\">Damian Clarke-Bruce<\/span> commented: <\/b><i>&#8220;We are pleased to welcome Ardena as a manufacturing partner, adding to our existing contracted manufacturing capability. Ardena&#8217;s position in <span class=\"xn-location\">Europe<\/span> ensures ease of access to RC220 product for our European clinical trials and adds a second source of FDA-compliant pharmaceutical grade product.&#8221;<\/i><\/p>\n<p>The initial development budget contracted is approximately USD <span class=\"xn-money\">$1m<\/span>. Ardena is expected to provide Race&#8217;s first EU and international compliant GMP supplies with goal of completion being by the end of 2023. Technology transfer to formally commence the program will occur in the coming months.<\/p>\n<p>The agreement with Ardena is for an initial period of 5 years and shall then be automatically extended for successive one year periods unless terminated earlier in accordance with the terms of the agreement.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Race Oncology executes agreement with leading global contract development and manufacturing organisation, Ardena as additional partner for GMP manufacturing of flagship RC220 bistanrene formulation Ardena has a long track record of providing sterile injectable products for all stages of clinical development Partnership strengthens the existing manufacturing programs by serving as a primary source for EU [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-20275","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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