{"id":1380,"date":"2023-01-12T09:29:05","date_gmt":"2023-01-12T00:29:05","guid":{"rendered":"https:\/\/pblogics.com\/about-cdo\/"},"modified":"2026-06-18T09:45:07","modified_gmt":"2026-06-18T00:45:07","slug":"cdo","status":"publish","type":"page","link":"https:\/\/prestigebiologics.com\/en\/cdo\/","title":{"rendered":"CDO"},"content":{"rendered":"<div class=\"et_pb_section_0 et_pb_section et_pb_fullwidth_section et_section_regular et_block_section\">\n<section class=\"et_pb_fullwidth_header_0 et_pb_fullwidth_header et_pb_bg_layout_dark et_pb_text_align_left et_pb_module et_flex_module\"><div class=\"et_pb_fullwidth_header_container left\"><div class=\"header-content-container center\"><div class=\"header-content et_flex_module\"><h3 class=\"et_pb_module_header\">CDO<\/h3><div class=\"et_pb_header_content_wrapper\"><p>Contract Development <span data-teams=\"true\">Organization<\/span><\/p>\n<\/div><div class=\"et_pb_header_button_wrapper\"><\/div><\/div><\/div><\/div><div class=\"et_pb_fullwidth_header_overlay\"><\/div><div class=\"et_pb_fullwidth_header_scroll\"><\/div><\/section>\n\n<div class=\"et_pb_fullwidth_menu_0 et_pb_fullwidth_menu et_pb_fullwidth_menu--without-logo et_pb_fullwidth_menu--style-left_aligned et_dropdown_animation_fade et_pb_bg_layout_dark et_pb_text_align_right-tablet et_pb_text_align_right-phone et_pb_module\"><div class=\"et_pb_row\"><div class=\"et_pb_menu__wrap\"><div class=\"et_pb_menu__menu\"><nav class=\"et-menu-nav fullwidth-menu-nav\"><ul id=\"menu-page_submenu_cdemo01\" class=\"et-menu fullwidth-menu nav et_disable_top_tier upwards\"><li id=\"menu-item-12616\" class=\"et_pb_menu_page_id-12236 menu-item menu-item-type-post_type menu-item-object-page menu-item-12616\"><a href=\"https:\/\/prestigebiologics.com\/overview\/\">Overview<\/a><\/li>\n<li id=\"menu-item-4192\" class=\"et_pb_menu_page_id-938 menu-item menu-item-type-post_type menu-item-object-page menu-item-4192\"><a href=\"https:\/\/prestigebiologics.com\/cdo\/\">CDO<\/a><\/li>\n<li id=\"menu-item-4194\" class=\"et_pb_menu_page_id-966 menu-item menu-item-type-post_type menu-item-object-page menu-item-4194\"><a href=\"https:\/\/prestigebiologics.com\/cmo\/\">CMO<\/a><\/li>\n<li id=\"menu-item-4195\" class=\"et_pb_menu_page_id-957 menu-item menu-item-type-post_type menu-item-object-page menu-item-4195\"><a href=\"https:\/\/prestigebiologics.com\/cpo\/\">CPO<\/a><\/li>\n<li id=\"menu-item-4191\" class=\"et_pb_menu_page_id-141 menu-item menu-item-type-post_type menu-item-object-page menu-item-4191\"><a href=\"https:\/\/prestigebiologics.com\/analytical_testing\/\">Analytical Testing<\/a><\/li>\n<\/ul><\/nav><\/div><div class=\"et_mobile_nav_menu\"><div class=\"mobile_nav et_pb_mobile_menu_upwards closed\"><span class=\"mobile_menu_bar\"><\/span><\/div><\/div><\/div><\/div><\/div>\n<\/div>\n\n<div class=\"et_pb_section_1 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_0 et_pb_row et_block_row\">\n<div class=\"et_pb_column_0 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_0 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\" id=\"service\"><div class=\"et_pb_text_inner\"><p>Contract Development Organization<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_divider_0 et_pb_divider et_pb_space et_pb_divider_position_top et_animated et_pb_module\"><div class=\"et_pb_divider_internal\"><\/div><\/div>\n\n<div class=\"et_pb_text_1 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p data-start=\"0\" data-end=\"196\">Prestige Biologics provides <strong>Contract Development Organization (CDO)<\/strong> services, supporting the full lifecycle of drug development from early nonclinical development through commercial manufacturing.<\/p>\n<p data-start=\"198\" data-end=\"425\" data-is-last-node=\"\" data-is-only-node=\"\">CDO services include Master Cell Bank manufacturing, as well as process technology development for upstream and downstream processes. The company also develops a range of analytical methods tailored to each product and process.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_2 et_pb_section et_section_regular et_block_section\" id=\"uspdsp\">\n<div class=\"et_pb_row_1 et_pb_row et_block_row\">\n<div class=\"et_pb_column_1 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_2 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h2>1. USP and DSP development<\/h2>\n<\/div><\/div>\n\n<div class=\"et_pb_text_3 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Prestige Biologics supports the seamless transition of partners\u2019 biopharmaceutical candidates from the research stage to commercial manufacturing through upstream process (USP) and downstream process (DSP) development.<\/p>\n<p>Based on its proprietary technologies and extensive experience, the company also provides optimized processes designed to ensure productivity, cost-effectiveness, and quality.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_2 et_pb_row et_block_row\">\n<div class=\"et_pb_column_2 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_4 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">1-1. Upstream process development<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_text_5 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">Prestige Biologics develops upstream processes designed to achieve cost-effective and highly productive cell culture operations.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_3 et_pb_row et_block_row\">\n<div class=\"et_pb_column_3 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_6 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">Method for Manufacturing Antibodies Through Glycan Content Control<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_text_7 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">This technology is based on the first identification that glycerol can increase the afucosylated content of antibodies, and enables the regulation of antibody glycan content using manganese and uridine. Through this approach, a high-quality target antibody population can be manufactured consistently. In addition, the cell culture process is simplified, offering improved efficiency in terms of both time and cost.<\/p>\n<\/div><\/div>\n\n<ul class=\"et_pb_icon_list_0 et_pb_icon_list et_pb_module et_flex_module\">\n<li class=\"et_pb_icon_list_item_0 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">Design of Experiment (DoE) Studies<\/div><\/li>\n\n<li class=\"et_pb_icon_list_item_1 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">Media\/Feed Development<\/div><\/li>\n\n<li class=\"et_pb_icon_list_item_2 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">Strategy Development<\/div><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_3 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_4 et_pb_row et_block_row\">\n<div class=\"et_pb_column_4 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_8 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">1-2. Downstream process development<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_text_9 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">Prestige Biologics develops optimized downstream purification processes.<\/p>\n<p style=\"text-align: left;\"><strong>Non-Protein A purification process for antibodies.<\/strong><\/p>\n<p style=\"text-align: left;\"><strong><\/strong><\/p>\n<\/div>\n<ul class=\"et_pb_icon_list_1 et_pb_icon_list et_pb_module et_flex_module\">\n<li class=\"et_pb_icon_list_item_3 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">Design of Experiment (DoE) Studies<\/div><\/li>\n\n<li class=\"et_pb_icon_list_item_4 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">Resin Screening\r\n<\/div><\/li>\n\n<li class=\"et_pb_icon_list_item_5 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">UF\/DF Development\r\n<\/div><\/li>\n\n<li class=\"et_pb_icon_list_item_6 et_pb_icon_list_item et_pb_module et_flex_module\"><span class=\"et-pb-icon\">5<\/span><div class=\"et_pb_icon_list_text\">Determination of In-Process Control and In-Process Testing (IPC & IPT) Conditions<\/div><\/li>\n<\/ul>\n<\/div>\n\n<div class=\"et_pb_image_0 et_pb_image et_pb_module et_block_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_DSP_Study.jpg\" width=\"1400\" height=\"600\" srcset=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_DSP_Study.jpg 1400w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_DSP_Study-1280x549.jpg 1280w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_DSP_Study-980x420.jpg 980w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_DSP_Study-480x206.jpg 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1400px, 100vw\" class=\"wp-image-4559\" title=\"cdmo_DSP_Study\" \/><\/span><\/div>\n\n<div class=\"et_pb_text_10 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: center;\">Protein A purification process vs Non-Protein A purification process<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_image_1 et_pb_image et_pb_module et_block_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Protein-A-Purification-Process_EN.png\" width=\"1808\" height=\"396\" srcset=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Protein-A-Purification-Process_EN.png 1808w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Protein-A-Purification-Process_EN-1280x280.png 1280w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Protein-A-Purification-Process_EN-980x215.png 980w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Protein-A-Purification-Process_EN-480x105.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1808px, 100vw\" class=\"wp-image-5141\" title=\"Protein A Purification Process_EN\" alt=\"Protein A Purification Process\" \/><\/span><\/div>\n\n<div class=\"et_pb_image_2 et_pb_image et_pb_module et_block_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Non-Protein-A-Purification-Process_EN.png\" width=\"1818\" height=\"412\" srcset=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Non-Protein-A-Purification-Process_EN.png 1818w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Non-Protein-A-Purification-Process_EN-1280x290.png 1280w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Non-Protein-A-Purification-Process_EN-980x222.png 980w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/05\/Non-Protein-A-Purification-Process_EN-480x109.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1818px, 100vw\" class=\"wp-image-5143\" title=\"Non-Protein A Purification Process_EN\" alt=\"Non-Protein A Purification Process\" \/><\/span><\/div>\n\n<div class=\"et_pb_text_11 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: center;\">Detailed purification steps may vary depending on the product.<br \/>Chon and Zarbis-Papastoitsis, 2011; Pinto et al., 2015; Xenopulos, 2015)<\/p>\n<p style=\"text-align: center;\">\n<\/div><\/div>\n\n<div class=\"et_pb_image_3 et_pb_image et_pb_module et_block_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/CDMO-NonProtein-A-DSP-02.png\" width=\"1378\" height=\"577\" srcset=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/CDMO-NonProtein-A-DSP-02.png 1378w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/CDMO-NonProtein-A-DSP-02-1280x536.png 1280w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/CDMO-NonProtein-A-DSP-02-980x410.png 980w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/CDMO-NonProtein-A-DSP-02-480x201.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1378px, 100vw\" class=\"wp-image-4565\" title=\"CDMO NonProtein A DSP 02\" \/><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_4 et_pb_section et_section_regular et_block_section\" id=\"form\">\n<div class=\"et_pb_row_5 et_pb_row et_block_row\">\n<div class=\"et_pb_column_5 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_12 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h2>2. Analytical Method Development<\/h2>\n<\/div><\/div>\n\n<div class=\"et_pb_text_13 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Analytical methods tailored to process and product characteristics are established to evaluate the various quality attributes required throughout drug development. Purity and impurity analyses are also performed to ensure product quality consistency and reliability.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_5 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_6 et_pb_row et_block_row\">\n<div class=\"et_pb_column_6 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_14 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h2>3. Non-GMP DS & DP Manufacturing and IND Filing Support<\/h2>\n<\/div><\/div>\n\n<div class=\"et_pb_text_15 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Continuous control is maintained over R&D and manufacturing processes related to DS and DP product quality, supporting systematic management across the drug development process. Development data required for IND filing are also provided, enabling stable drug development through support for regulatory submission documentation.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_6 et_pb_section et_section_regular et_block_section\"><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"iawp_total_views":249,"footnotes":""},"class_list":["post-1380","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CDO - PRESTIGE BIOLOGICS<\/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:\/\/prestigebiologics.com\/en\/cdo\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDO - 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