{"id":2306,"date":"2018-12-15T10:55:33","date_gmt":"2018-12-15T01:55:33","guid":{"rendered":"http:\/\/spera.rdy.jp\/?page_id=2306"},"modified":"2019-02-22T01:32:10","modified_gmt":"2019-02-21T16:32:10","slug":"development","status":"publish","type":"page","link":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/services\/development\/","title":{"rendered":"Drug substance process development"},"content":{"rendered":"<p>Please contact us using this website <a href=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/inquiry\/\" class=\"no-wrap\">inquiry form<\/a> if you have any requests or questions concerning drug substance process development.<\/p>\n<p>Click on each item below for more details.<\/p>\n<ul class=\"btG4\">\n<li>\n\t\t<span class=\"service_ttl\">Develop API manufacturing process and the quality design from \u201czero-level\u201d, considering customer\u2019s development stage, based on the know-how that leading Japanese pharmaceutical company has fostered.<\/span><\/p>\n<ul class=\"service_text\">\n<li>World-top-level technologies and rich experiences on asymmetric synthesis; particularly, asymmetric metal-catalyzed reaction.<\/li>\n<li>Synthetic technologies and the experiences to apply various\/diversified reactions for API process R&#038;D to the<br \/>\nlarge-scale manufacturing.\n<\/li>\n<li>Scale-up simulation technologies with various R&#038;D experiences for the unit operation (e.g. reaction, concentration, crystallization, filtration, desiccation and grinding).<\/li>\n<li>High-level process control technologies including highly-sensitive analytical methods and structure determination of API related substances.<\/li>\n<li>Process optimizations based on the statistical design of experiment (DoE).<\/li>\n<li>Flow chemistry technologies with various equipment from small-scale to kg-scale for dealing with various reactions.<\/li>\n<li>We perform drug substance coformer (second component) screening to select the solid form to become a development candidate, through formation of an appropriate salt, co-crystal or crystal form, to improve the drug substance properties (solubility, hygroscopicity, stability, formulation properties, etc.).<\/li>\n<\/ul>\n<\/li>\n<li>\n\t\t<span class=\"service_ttl\">Correspond flexibly to the needs of API manufacturing.<\/span><\/p>\n<ul class=\"service_text\">\n<li>Establish and provide a supply chain of API manufacturing which is appropriate to each goal using networks with reliable partner CMO flexibly.<\/li>\n<li>Conduct manufacturing\u2013non-GMP or GMP\u2013aiming to scale-up confirmation study using in-house facilities.<\/li>\n<\/ul>\n<\/li>\n<li>\n\t\t<span class=\"service_ttl\">Support precisely regulatory filing for clinical studies and commercial application.<\/span><\/p>\n<ul class=\"service_text\">\n<li>Conduct API process R&#038;D, and propose the development plan with a balance between speed, economy and quality, by considering regulatory requirements on each development stage from the early-stage, based on our rich experiences on IND\/NDA\/MAA application.<\/li>\n<li>Provide our capability to construct an API process control strategy (e.g. impurity controls including potential mutagenic impurities and designation of regulatory starting material).<\/li>\n<li>Propose an optimal regulatory filing strategy based on the rich experiences.<\/li>\n<li>Support regulatory filing, obtaining data required for the application, preparing the documents and<br \/>\ncorresponding to the inquiries from health authorities.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4>Technologies and Achievements<\/h4>\n<p>Go <a href=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/technology\/\" class=\"no-wrap\">here<\/a> for details on our technologies and achievements.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Please contact us using this website inquiry form if you have any requests or questions concerning drug substa [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2300,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_locale":"en_US","_original_post":"51","footnotes":""},"class_list":["post-2306","page","type-page","status-publish","hentry","en-US"],"acf":[],"_links":{"self":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2306","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/comments?post=2306"}],"version-history":[{"count":5,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2306\/revisions"}],"predecessor-version":[{"id":4745,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2306\/revisions\/4745"}],"up":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2300"}],"wp:attachment":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/media?parent=2306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}