{"id":15534,"date":"2021-10-22T00:00:00","date_gmt":"2021-10-22T00:00:00","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/olon-ricerca-bioscience\/"},"modified":"2023-08-28T14:56:30","modified_gmt":"2023-08-28T14:56:30","slug":"olon-ricerca-bioscience","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/manufacturing\/api-excipients\/olon-ricerca-bioscience\/","title":{"rendered":"Olon Group announces the next strategic milestone of Olon Ricerca Bioscience"},"content":{"rendered":"<p style=\"text-align: right;\"><span class=\"td_text_highlight_marker_red td_text_highlight_marker\">COMPANY NEWS<\/span><\/p>\r\n\r\n<h3 class=\"wp-block-heading\"><strong>A new space to produce highly potent APIs<\/strong><\/h3>\r\n\r\n\r\n\r\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>Now, we can take clients from pre-clinical to phase II and then, if the project is successful, transfer the technology to our European sites for phase III\/commercial. We offer our customers a full partnership from preclinical up to commercial<\/p><cite>ORB CEO Luigi Trussardo<\/cite><\/blockquote>\r\n\r\n\r\n\r\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<p><strong><a href=\"https:\/\/makingconnect.it\/en\/company\/olon\/\">Olon Group<\/a> is pleased to announce the next strategic development milestone of Olon Ricerca Bioscience, the campus located in Ohio (US), mostly focused on R&amp;D. The latest investments for Olon Ricerca Bioscience (ORB) are to set up a new line to produce highly potent APIs (HPAPIs).<\/strong><\/p>\r\n\r\n\r\n\r\n<p>So Olon, that has years of expertise in HPAPIs, makes ORB be aligned with that technology, to bring on clients that need HPAPIs in clinical phases, as early as possible. In the near future the company could offer HPAPIs for early clinical phases and then transfer programs to the European sites for later-phase clinical and beyond.<\/p>\r\n\r\n\r\n\r\n<p>ORB campus has officially begun the investment in HPAPI capabilities. Over the long term, the plan is to increase its capacity to meet demand up to a hundred grams and bring U.S. site to mirror the capacity of the Italian facilities, which includes multiple sites that can perform the production of HPAPIs on a larger scale.<\/p>\r\n\r\n\r\n\r\n<p>ORB has also expanded its capacity, closing the gap between preclinical phase and commercial production, where it already played, adding on capabilities for the initial development of new chemical entities (NCEs).<\/p>\r\n\r\n\r\n\r\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>Now, we can take clients from pre-clinical to phase II and then, if the project is successful, transfer the technology to our European sites for phase III\/commercial. We offer our customers a full partnership from preclinical up to commercial. Although we don\u2019t carry out production from start to finish of the API development at the same site, our customers appreciate the fact that their program can be completed through a single provider. Up to know we have already several examples demonstrating the smooth technological transfer of processes and analytics between the two side of the oceans within the same quality and operational system<\/p><cite>Luigi Trussardo, CEO of Olon Ricerca Bioscience<\/cite><\/blockquote>\r\n\r\n\r\n\r\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\r\n\r\n\r\n\r\n<p>Olon Ricerca is in northeast Ohio, 30 miles east of Cleveland. The campus consists of two buildings and is divided into four operation departments.<\/p>\r\n\r\n\r\n\r\n<p>ORB relies on an analytical department that provides a comprehensive range of on-site analytical chemistry services to fully support the drug development process, from preclinical to post-marketing phases. It has decades of experience conducting studies in compliance with the US FDA\u2013 GLP\/cGMP regulatory requirements and the International Conference on Harmonization (ICH), providing this offering as a standalone business. The synthetic chemistry group is comprised of 20 people who are providing services supporting the discovery phase (early-stage scaffold\/analog synthesis, lead optimization, preclinical compound synthesis support to acute\/tox studies), with preparation of mg to 1 kg amounts for active ingredients and advanced intermediates, as well as metabolites\/Impurities and reference standards. ORB then has the two groups that are more dedicated to GMP \u2014 process chemistry and process development &amp; manufacturing. Process chemistry includes the chemists that support the progression of drug candidates and specialty materials through all phases of development and manufacture. In process development and manufacturing, ORB produces API and intermediates.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\">Related posts<\/h2>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/makingconnect.it\/en\/highly-potent-api-expansion-for-olon-rodano-site\/\">Highly potent API expansion for Olon Rodano site<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/makingconnect.it\/en\/production-of-proteins-with-advanced-and-sustainable-approach\/\">Production of proteins with advanced and sustainable approach<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>COMPANY NEWS A new space to produce highly potent APIs Now, we can take clients from pre-clinical to phase II and then, if the project is successful, transfer the technology to our European sites for phase III\/commercial. We offer our customers a full partnership from preclinical up to commercial ORB CEO Luigi Trussardo Olon Group [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":15659,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[812],"tags":[],"class_list":{"0":"post-15534","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-api-excipients"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Olon Group announces the next strategic milestone of Olon Ricerca Bioscience - MakingPharmaIndustry<\/title>\n<meta name=\"description\" content=\"Olon Group announces the next strategic milestone of Olon Ricerca Bioscience, a new space to produce highly potent APIs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/makingpharmaindustry.it\/en\/manufacturing\/api-excipients\/olon-ricerca-bioscience\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Olon Group announces the next strategic milestone of Olon Ricerca Bioscience - 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