{"id":580,"date":"2022-12-15T08:53:43","date_gmt":"2022-12-14T23:53:43","guid":{"rendered":"https:\/\/pblogics.com\/quality-control-and-assurance\/"},"modified":"2026-06-18T09:49:21","modified_gmt":"2026-06-18T00:49:21","slug":"analytical_testing","status":"publish","type":"page","link":"https:\/\/prestigebiologics.com\/en\/analytical_testing\/","title":{"rendered":"Analytical Testing"},"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_section_parallax et_pb_module et_flex_module\"><span class=\"et-pb-parallax-wrapper\"><span class=\"et-pb-parallax-background et-pb-parallax-background-module--divi-fullwidth-header-0\" style=\"background-image:url(https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/CDMO-Analy-02.png)\"><\/span><\/span><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\">Analytical Testing<\/h3><div class=\"et_pb_header_content_wrapper\"><p>&nbsp;<\/p>\n<p>Analytical Testing<\/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_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_0 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>Experienced analytical researchers have a wide range of analytical experience and related knowledge.<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_text_1 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><span>Fast, reliable and accurate method development enables efficient process development and production.<\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_divider_1 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<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_2 et_pb_section et_section_regular et_block_section\" id=\"qa\">\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\"><h4>Quality Assurance<\/h4>\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\"><h2><span>Clean quality control and assurance<\/span><\/h2>\n<p>Prestige Biologics conducts environmental monitoring on a weekly to monthly basis, and manages the cleanliness of production facilities and test facilities at the world's highest level through identification and disinfection tests, and has a record of zero pollution \/ accident.<\/p>\n<p>Prestige Biologics has experience in the development and production of new antibodies as well as biosimilars.<\/p>\n<p>With the goal of providing high quality clinical and commercial product supplies to our customers and patients, we continuously improve our research and development, manufacturing and quality systems and processes to maintain the highest level of regulatory compliance.<\/p>\n<\/div><\/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_Analystic.jpg\" width=\"1400\" height=\"600\" srcset=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_Analystic.jpg 1400w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_Analystic-1280x549.jpg 1280w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_Analystic-980x420.jpg 980w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/04\/cdmo_Analystic-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-4570\" title=\"cdmo_Analystic\" \/><\/span><\/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_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: center;\">Featured Test Methods and Equipment<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_code_0 et_pb_code et_pb_module\"><div class=\"et_pb_code_inner\">  <table>\n               \n                        <colgroup>\n                            <col style=\"width:33.3%\" span=\"3\">\n                        <\/colgroup>\n                        <thead>\n                        <tr style=\"text-align:center\">\n                            <th scope=\"col\">Sample Control<\/th>\n <th scope=\"col\" colspan=\"2\">Best Test Capabilities<\/th>\n                        <\/tr>\n                        <\/thead>\n                        <tbody>\n                        <tr>\n                            <td>Store each sample in an independent chamber<\/td>\n                            <td colspan=\"2\">\n                                <strong>Raw Materials > Manufacturing > DS \/ DP Release > Stability Test<\/strong>\n                                <ul class=\"list2\">\n                                    <li> Quality control of all items from raw material warehousing to stability of DS \/ DP<\/li>\n                                <\/ul>\n                            <\/td>\n                        <\/tr>\n                        <tr>\n                            <td rowspan=\"4\">\n                                <strong>Thorough storage and management of samples<\/strong>\n                                <ul class=\"list2\">\n                                    <li>Raw materials<\/li>\n                                    <li>Retention samples<\/li>\n                                    <li>DS \/ DP samples<\/li>\n                                    <li>DS \/ DP retention samples<\/li>\n                                    <li>Stability DS \/ DP samples<\/li>\n                                    <li>Stability DS \/ DP Retention Samples<\/li>\n                                <\/ul>\n                            <\/td>\n                            <td>Physical Chemistry Test<\/td>\n                            <td>\n                                <ul class=\"list2\">\n                                    <li>pH, Osmolarity, Protein content, Appearance<\/li>\n                                    <li>FT-IR<\/li>\n                                    <li>HPLC<\/li>\n                                    <li>GC, ICP<\/li>\n                                    <li>Peptide Mapping<\/li>\n                                    <li>Specific optical rotation, etc<\/li>\n                                <\/ul>\n                            <\/td>\n                        <\/tr>\n                        <tr>\n                            <td>Biochemistry Test<\/td>\n                            <td>\n                                <ul class=\"list2\">\n                                    <li>ELISA (enzyme-linked immunosorbent assay)<\/li>\n                                    <li>Real Time PCR<\/li>\n                                    <li>Automated Electrophoresis<\/li>\n                                    <li>Anti-proliferation assay, etc.<\/li>\n                                <\/ul>\n                            <\/td>\n                        <\/tr>\n                        <tr>\n                            <td>Microbial Test<\/td>\n                            <td>\n                                <ul class=\"list2\">\n                                    <li>Bioburden<\/li>\n                                    <li>Endotoxin<\/li>\n                                    <li>Microbial limit<\/li>\n                                    <li>Sterility, etc.<\/li>\n                                <\/ul>\n                            <\/td>\n                        <\/tr>\n                        <tr>\n                            <td>Environmental<\/td>\n <td>and water monitoring<\/td>\n                        <\/tr>\n                        <\/tbody>\n                    <\/table><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_3 et_pb_section et_section_regular et_block_section\" id=\"reg\">\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_5 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h4>Regulatory<\/h4>\n<\/div><\/div>\n\n<div class=\"et_pb_text_6 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h2>Regulatory Support<\/h2>\n<\/div><\/div>\n\n<div class=\"et_pb_text_7 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p><b>Fast and safe original drug production through<\/b> <b>Full Single-Use System<\/b><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_text_8 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\">As a common international format for drug approval related to drug quality, it is documented and verified that R&amp;D and manufacturing processes related to the quality of drugs (DS, DP) are consistently controlled and managed during the drug development process.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\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_cta_0 et_pb_promo et_pb_bg_layout_dark et_pb_module et_block_module\" id=\"ctd\"><div class=\"et_pb_promo_description\"><h2 class=\"et_pb_module_header\">CTD Triangle<\/h2><div class=\"et_pb_promo_content\"><div class=\"\" data-turn-id-container=\"30869289-8207-4a0e-8eb9-17948707c760\" data-is-intersecting=\"true\">\n<section class=\"text-token-text-primary w-full focus:outline-none has-data-writing-block:pointer-events-none [&amp;:has([data-writing-block])&gt;*]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-(--header-height)\" dir=\"auto\" data-turn-id=\"30869289-8207-4a0e-8eb9-17948707c760\" data-turn-id-container=\"30869289-8207-4a0e-8eb9-17948707c760\" data-testid=\"conversation-turn-3\" data-scroll-anchor=\"false\" data-turn=\"user\"><\/section>\n<\/div>\n<div class=\"\" data-turn-id-container=\"request-WEB:ef9e7052-9f7d-4e03-b829-01f8a7fba5f8-1\" data-is-intersecting=\"true\">\n<section class=\"text-token-text-primary w-full focus:outline-none has-data-writing-block:pointer-events-none [&amp;:has([data-writing-block])&gt;*]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]\" dir=\"auto\" data-turn-id=\"request-WEB:ef9e7052-9f7d-4e03-b829-01f8a7fba5f8-1\" data-turn-id-container=\"request-WEB:ef9e7052-9f7d-4e03-b829-01f8a7fba5f8-1\" data-testid=\"conversation-turn-4\" data-scroll-anchor=\"false\" data-turn=\"assistant\">\n<div class=\"text-base my-auto mx-auto pb-10 [--thread-content-margin:var(--thread-content-margin-xs,calc(var(--spacing)*4))] @w-sm\/main:[--thread-content-margin:var(--thread-content-margin-sm,calc(var(--spacing)*6))] @w-lg\/main:[--thread-content-margin:var(--thread-content-margin-lg,calc(var(--spacing)*16))] px-(--thread-content-margin)\">\n<div class=\"[--thread-content-max-width:40rem] @w-lg\/main:[--thread-content-max-width:48rem] mx-auto max-w-(--thread-content-max-width) flex-1 group\/turn-messages focus-visible:outline-hidden relative flex w-full min-w-0 flex-col agent-turn\">\n<div class=\"flex max-w-full flex-col gap-4 grow\">\n<div data-message-author-role=\"assistant\" data-message-id=\"63b85dac-8a8b-4ea8-914c-17cd5198dcee\" dir=\"auto\" data-message-model-slug=\"gpt-5-5\" class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal outline-none keyboard-focused:focus-ring [.text-message+&amp;]:mt-1\" data-turn-start-message=\"true\" tabindex=\"0\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden\">\n<div class=\"markdown prose dark:prose-invert wrap-break-word w-full dark markdown-new-styling\">\n<p data-start=\"0\" data-end=\"394\" data-is-last-node=\"\" data-is-only-node=\"\">The five modules of the Common Technical Document (CTD), an internationally harmonized format used to present information on the quality, safety, and efficacy of pharmaceutical products, are often illustrated using the CTD Triangle to describe the document structure. Module 1 contains region-specific information, while Modules 2, 3, 4, and 5 contain content that is common across all regions.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div><\/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\/03\/ctd_triangle.jpg\" width=\"1299\" height=\"637\" srcset=\"https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/03\/ctd_triangle.jpg 1299w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/03\/ctd_triangle-1280x628.jpg 1280w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/03\/ctd_triangle-980x481.jpg 980w, https:\/\/prestigebiologics.com\/wp-content\/uploads\/2023\/03\/ctd_triangle-480x235.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) 1299px, 100vw\" class=\"wp-image-3224\" title=\"ctd_triangle\" \/><\/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\">\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_divider_2 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_9 et_pb_text et_pb_bg_layout_light et_animated et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><p>eCTD<\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_text_10 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><table border=\"1\" style=\"border-collapse: collapse; width: 100%;\">\n<tbody>\n<tr>\n<td style=\"width: 50%; text-align: center;\"><span class=\"num\"><strong>Module 1<\/strong><\/span><\/td>\n<td style=\"width: 50%;\"><span class=\"num\">Administrative information and prescribing information<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 50%; text-align: center;\"><span class=\"num\"><strong>Module 2<\/strong><\/span><\/td>\n<td style=\"width: 50%;\">Common technical document summaries<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 50%; text-align: center;\"><span class=\"num\"><strong>Module 3<\/strong><\/span><\/td>\n<td style=\"width: 50%;\">Quality<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 50%; text-align: center;\"><span class=\"num\"><strong>Module 4<\/strong><\/span><\/td>\n<td style=\"width: 50%;\">Non-clinical study reports<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 50%; text-align: center;\"><span class=\"num\"><strong>Module 5<\/strong><\/span><\/td>\n<td style=\"width: 50%;\">Clinical study reports<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p style=\"text-align: center;\">\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/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":217,"footnotes":""},"class_list":["post-580","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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