{"id":987503110,"date":"2026-07-24T17:41:08","date_gmt":"2026-07-24T17:41:08","guid":{"rendered":"https:\/\/boracdmo.com\/?p=987503110"},"modified":"2026-07-24T18:58:21","modified_gmt":"2026-07-24T18:58:21","slug":"de-risking-production-of-complex-oral-solid-dosages-considerations-key-capabilities","status":"publish","type":"post","link":"https:\/\/boracdmo.com\/de-risking-production-of-complex-oral-solid-dosages-considerations-key-capabilities\/","title":{"rendered":"De-risking production of complex oral solid dosages: Considerations &#038; key capabilities"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"987503110\" class=\"elementor elementor-987503110\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-32400f0 e-flex e-con-boxed e-con e-parent\" data-id=\"32400f0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-e38e601 e-con-full e-flex e-con e-child\" data-id=\"e38e601\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-294ece2 elementor-widget elementor-widget-heading\" data-id=\"294ece2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">De-risking production of complex oral solid dosages: Considerations &amp; key capabilities<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2bf2d2a elementor-position-right elementor-vertical-align-middle elementor-widget elementor-widget-image-box\" data-id=\"2bf2d2a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img fetchpriority=\"high\" decoding=\"async\" width=\"583\" height=\"747\" src=\"https:\/\/boracdmo.com\/wp-content\/uploads\/sites\/2\/2026\/07\/de-risking-production-complex-OSD-white-paper-1.png\" class=\"attachment-full size-full wp-image-987503112\" alt=\"de-risking-production-complex-OSD-white-paper-thumbnail\" srcset=\"https:\/\/boracdmo.com\/wp-content\/uploads\/sites\/2\/2026\/07\/de-risking-production-complex-OSD-white-paper-1.png 583w, https:\/\/boracdmo.com\/wp-content\/uploads\/sites\/2\/2026\/07\/de-risking-production-complex-OSD-white-paper-1-234x300.png 234w\" sizes=\"(max-width: 583px) 100vw, 583px\" \/><\/figure><div class=\"elementor-image-box-content\"><p class=\"elementor-image-box-description\">As oral solid dose (OSD) products become increasingly complex, drug developers face growing challenges related to formulation, manufacturing, scale-up, and commercialization. Highly potent APIs (HPAPIs), controlled substances, poorly soluble compounds, and advanced formulation technologies require specialized expertise, manufacturing capabilities, and integrated development strategies to establish scalable processes and reduce manufacturing risk.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2ee341f e-con-full e-flex e-con e-child\" data-id=\"2ee341f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aa74863 elementor-widget elementor-widget-text-editor\" data-id=\"aa74863\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Manufacturing risk in complex OSD programs rarely results from a single challenge. Instead, it often emerges through the interaction of formulation complexity, process development, scale-up, technology transfer, and commercialization. As regulatory expectations increase and timelines become more demanding, drug developers must proactively address these risks to support robust, reproducible manufacturing processes throughout the product lifecycle.<\/p><p>\u00a0<\/p><p>This white paper examines the technical and operational considerations associated with manufacturing complex oral solid dose products. It explores challenges related to HPAPIs, controlled substances, solubility enhancement techniques, and advanced formulation technologies, while outlining the specialized capabilities that support scalable development, efficient technology transfer, and commercial manufacturing.<\/p><p>\u00a0<\/p><p>Readers will also learn how Bora Pharmaceuticals supports complex oral solid dose programs through integrated development and manufacturing capabilities at its Maple Grove, Minnesota facility. From advanced formulation technologies and scalable equipment platforms to HPAPI containment, controlled substance expertise, solvent handling capabilities, and cross-functional technical support, the paper highlights the capabilities Bora provides to help support complex OSD development and manufacturing.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65d871d elementor-widget elementor-widget-heading\" data-id=\"65d871d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">What you\u2019ll learn<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7daf71a elementor-widget elementor-widget-text-editor\" data-id=\"7daf71a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li>Challenges associated with manufacturing complex oral solid dose products<\/li><li>Key risks that can emerge during development, scale-up, technology transfer, and commercialization<\/li><li>Specialized capabilities that support complex oral solid dose manufacturing<\/li><li>How integrated development and manufacturing strategies can help reduce manufacturing risk<\/li><li>Bora Pharmaceuticals&#8217; capabilities for supporting complex oral solid dose development and manufacturing<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-52df253 e-con-full e-flex e-con e-child\" data-id=\"52df253\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b02123e elementor-widget elementor-widget-html\" data-id=\"b02123e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/embed\/v2.js\"><\/script>\n<script>\n  hbspt.forms.create({\n    portalId: \"7282915\",\n    formId: \"0d89945a-6c67-47be-8ad1-4662c8b99884\",\n    region: \"na1\",\n    onFormReady: function($form) {\n\t\tconst keysToFill = window.APP_TRACKING_CONFIG.paramKeys;\n\n\t\tkeysToFill.forEach((key) => {\n\t\t\tconst value = localStorage.getItem(key);\n\t\t\t\n\t\t\tif (value) {\n\t\t\t\t$form.find('input[name=\"' + key + '\"]') .val(value).change();\n\t\t\t}\n\t\t});\n\t\t\n\n\t\t$form.find('input[name=\"form_name\"]').val(\"content download\");\n\t\t$form.find('input[name=\"form_usage\"]').val(\"de-risking-production-complex-OSD-white-paper\").change();\n\t\t$form.find('input[name=\"page_url\"]').val(window.location.href).change();\n\t},\n    onFormSubmitted: function($form) {\n        window.open('https:\/\/boracdmo.com\/wp-content\/uploads\/sites\/2\/2026\/07\/de-risking-production-complex-OSD-white-paper.pdf', '_blank', 'noopener,noreferrer');\n    }\n  });\n<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-40990a4 e-flex e-con-boxed e-con e-parent\" data-id=\"40990a4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Download Bora Pharmaceuticals&#8217; white paper exploring key considerations, manufacturing risks, and specialized capabilities for complex oral solid dose development and manufacturing.<\/p>\n","protected":false},"author":43,"featured_media":987502696,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"_acf_changed":false,"content-type":"","_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[75],"tags":[],"class_list":["post-987503110","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pdf-post"],"aioseo_notices":[],"acf":[],"_links":{"self":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/987503110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/comments?post=987503110"}],"version-history":[{"count":7,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/987503110\/revisions"}],"predecessor-version":[{"id":987503119,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/posts\/987503110\/revisions\/987503119"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media\/987502696"}],"wp:attachment":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media?parent=987503110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/categories?post=987503110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/tags?post=987503110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}