{"id":3423,"date":"2020-02-12T08:44:14","date_gmt":"2020-02-12T08:44:14","guid":{"rendered":"https:\/\/junglefish.net\/dem\/chime\/?post_type=portfolio&#038;p=3423"},"modified":"2025-06-25T16:09:44","modified_gmt":"2025-06-25T08:09:44","slug":"regulatory-cmc-support","status":"publish","type":"portfolio","link":"https:\/\/chimebiologics.com\/zh\/cdmo-item\/regulatory-cmc-support\/","title":{"rendered":"\u6ce8\u518c\u670d\u52a1"},"content":{"rendered":"<div class='flex_column av-41j8e-fa36f75815485dfccfa68c05fc0bdcad av_two_fifth  avia-builder-el-0  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k6g6sogs-edee198e250a88a2a8a8ae1f165f4b3e\">\n.avia-image-container.av-k6g6sogs-edee198e250a88a2a8a8ae1f165f4b3e img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-k6g6sogs-edee198e250a88a2a8a8ae1f165f4b3e .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-k6g6sogs-edee198e250a88a2a8a8ae1f165f4b3e av-styling-no-styling avia-align-center  avia-builder-el-1  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-3594 avia-img-lazy-loading-not-3594 avia_image ' src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup.jpg\" alt='' title='CDMO-reg-CMC-sup'  height=\"1000\" width=\"800\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup.jpg 800w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup-240x300.jpg 240w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup-768x960.jpg 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup-564x705.jpg 564w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup-450x563.jpg 450w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/div><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-38ep6-5b9abd869c3b83df58f92155e7fd3b9d\">\n.flex_column.av-38ep6-5b9abd869c3b83df58f92155e7fd3b9d{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-38ep6-5b9abd869c3b83df58f92155e7fd3b9d av_three_fifth  avia-builder-el-2  el_after_av_two_fifth  el_before_av_section  avia-builder-el-last  flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-k6g6u1z5-bada71189c63042784d4144d37917bdd'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><\/p>\n<h1>\u6ce8\u518c\u670d\u52a1<\/h1>\n<blockquote>\n<p>\u6211\u4eec\u63d0\u4f9b\u5168\u7403\u8303\u56f4\u7684\u6ce8\u518c\u652f\u6301\uff0c\u5305\u62ec\u56fd\u5185\u5916IND\/BLA\u7533\u62a5\u670d\u52a1<\/p>\n<\/blockquote>\n<p>\u6211\u4eec\u4e3a\u5ba2\u6237\u63d0\u4f9b\u5305\u62ec\u54a8\u8be2\u670d\u52a1\u3001\u7533\u62a5\u7b56\u7565\u5236\u5b9a\u3001\u53ec\u5f00\u79d1\u5b66\u54a8\u8be2\u4f1a\u8bae\u3001\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u64b0\u5199\u3001\u534f\u52a9\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u3001\u534f\u52a9\u7b54\u590d\u5ba1\u8bc4\u610f\u89c1\u53ca\u8865\u5145\u8d44\u6599\u63d0\u4ea4\u7b49\u5de5\u4f5c\u5728\u5185\u7684\u5168\u65b9\u4f4d\u6ce8\u518c\u6cd5\u89c4\u670d\u52a1\u3002<\/p>\n<p>\u6211\u4eec\u5177\u5907\u64b0\u5199\u6ee1\u8db3\u4e2d\u56fd\u3001\u7f8e\u56fd\u548c\u6b27\u6d32\u6ce8\u518c\u7533\u62a5\u8981\u6c42\u7684\u4e2d\u82f1\u6587\u8d44\u6599\u7684\u80fd\u529b\uff0c\u540c\u65f6\u62e5\u6709\u4e2d\u7f8e\u6b27\u7b49\u591a\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08IND\/CTA\uff09\u548c\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\/BLA\/MAA\uff09\u7684\u4e30\u5bcc\u7684\u6210\u529f\u7ecf\u9a8c\u3002<\/p>\n<p>\u6211\u4eec\u7684\u6ce8\u518c\u6cd5\u89c4\u56e2\u961f\u4e0e\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u6b27\u76df\u3001\u6fb3\u5927\u5229\u4e9a\u4ee5\u53ca\u5176\u4ed6\u4e9a\u6d32\u56fd\u5bb6\u7684\u76d1\u7ba1\u673a\u6784\u5efa\u7acb\u4e86\u5bc6\u5207\u4e14\u826f\u597d\u7684\u5de5\u4f5c\u5173\u7cfb\uff0c\u5145\u5206\u4e86\u89e3\u76d1\u7ba1\u673a\u6784\u7684\u6cd5\u5f8b\u6cd5\u89c4\uff0c\u80fd\u591f\u5168\u9762\u5730\u4e3a\u5ba2\u6237\u5728\u4ea7\u54c1\u7814\u53d1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u63d0\u4f9b\u6cd5\u89c4\u7b56\u7565\u6307\u5bfc\u3002<\/p>\n<hr \/>\n<p><strong>Scendea \u516c\u53f8\u4f5c\u4e3a\u9f0e\u5eb7\u7684\u6218\u7565\u5408\u4f5c\u673a\u6784\uff0c\u53ef\u4ee5\u5171\u540c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u66f4\u5168\u9762\u7684\u6ce8\u518c\u76d1\u7ba1\u670d\u52a1\u3002<\/strong><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-4034\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-300x64.png\" sizes=\"auto, (max-width: 267px) 100vw, 267px\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-300x64.png 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-1030x220.png 1030w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-768x164.png 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-1536x328.png 1536w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-2048x438.png 2048w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-1500x321.png 1500w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-705x151.png 705w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/Scendea_Tagline-Blue-450x96.png 450w\" alt=\"\" width=\"267\" height=\"57\" \/><\/p>\n<p>Scendea\u662f\u4e00\u5bb6\u4e00\u6d41\u7684\u751f\u7269\u533b\u836f\u4ea7\u54c1\u7814\u53d1\u548c\u54a8\u8be2\u516c\u53f8\uff0c\u5176\u6838\u5fc3\u56e2\u961f\u5df2\u7ec4\u5efa\u4e8620\u591a\u5e74\uff0c\u53c2\u4e0e\u4e861000\u591a\u4e2a\u9879\u76ee\u7684\u7814\u53d1\uff0c\u56e2\u961f\u6210\u5458\u904d\u5e03\u82f1\u56fd\u3001\u7231\u5c14\u5170\u3001\u8377\u5170\u548c\u7f8e\u56fd\u7b49\u3002Scendea\u7684\u4e13\u5bb6\u56e2\u961f\u53ef\u4ee5\u5728\u8d28\u91cf\/\u836f\u5b66\uff08CMC\uff09\u3001\u975e\u4e34\u5e8a\/\u6bd2\u7406\u5b66\u3001\u4e34\u5e8a\/\u533b\u5b66\u548c\u6cd5\u89c4\u76d1\u7ba1\u7b49\u9886\u57df\u63d0\u4f9b\u6218\u7565\u6307\u5bfc\u548c\u64cd\u4f5c\u652f\u6301\uff0c\u6210\u529f\u5730\u6307\u5bfc\u4ea7\u54c1\u4ece\u65e9\u671f\u5f00\u53d1\u5230\u6279\u51c6\u4e0a\u5e02\u3002\u79d1\u5b66\u80cc\u666f\u3001\u884c\u4e1a\u7ecf\u9a8c\u548c\u5546\u4e1a\u610f\u8bc6\u7684\u5b8c\u7f8e\u7ed3\u5408\uff0c\u81f4\u4f7fScendea\u80fd\u591f\u4e3a\u4e0e\u533b\u836f\u4ea7\u54c1\u5f00\u53d1\u76f8\u5173\u95ee\u9898\u63d0\u4f9b\u89e3\u51b3\u65b9\u6848\uff0c\u540c\u65f6\u7b26\u5408\u5404\u65b9\u6cd5\u89c4\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42\u3002<\/p>\n<p><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_1'  class='avia-section av-2s3qm-b219104a35d6730b9de161db0dcbcff2 main_color avia-section-default avia-no-shadow  avia-builder-el-4  el_after_av_three_fifth  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3423'><div class='entry-content-wrapper clearfix'>\n<section  class='av_textblock_section av-24rdu-e327b1c8784f7269d240ede6f268326b'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h4 style=\"text-align: center;\">\u670d\u52a1\u9879\u76ee<br \/>\n<\/h4>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k7d2ewy1-54b62fc362249b620c16aea745c587c9\">\n#top .hr.hr-invisible.av-k7d2ewy1-54b62fc362249b620c16aea745c587c9{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-k7d2ewy1-54b62fc362249b620c16aea745c587c9 hr-invisible  avia-builder-el-6  el_after_av_textblock  el_before_av_masonry_entries  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div id='av-masonry-1' class='av-masonry av-k6j0j5rr-fb9356f1b1c13bef6b492838ecf1017d noHover av-fixed-size av-large-gap av-hover-overlay-grayscale av-masonry-animation-active av-masonry-col-3 av-caption-always av-caption-style- av-masonry-entries '><div class=\"av-masonry-container isotope av-js-disabled\"><div class='av-masonry-entry isotope-item av-masonry-item-no-image '><\/div><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/cell-line-development\/\"  id='av-masonry-1-item-3405' data-av-masonry-item='3405' class='av-masonry-entry isotope-item post-3405 portfolio type-portfolio status-publish has-post-thumbnail hentry tag-59 portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-cell-line-dev\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-cell-line-dev-1-564x705.jpg);\"  title=\"CDMO-cell-line-dev\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u7ec6\u80de\u682a\u5f00\u53d1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/process-development\/\"  id='av-masonry-1-item-3412' data-av-masonry-item='3412' class='av-masonry-entry isotope-item post-3412 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-proc-dev\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-proc-dev-1-564x705.jpg);\"  title=\"CDMO-proc-dev\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u5de5\u827a\u5f00\u53d1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/protein-science-group\/\"  id='av-masonry-1-item-3408' data-av-masonry-item='3408' class='av-masonry-entry isotope-item post-3408 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-prot-science-grp\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-prot-science-grp-1-564x705.jpg);\"  title=\"CDMO-prot-science-grp\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u5206\u6790\u65b9\u6cd5\u5f00\u53d1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/technology-transfer\/\"  id='av-masonry-1-item-3414' data-av-masonry-item='3414' class='av-masonry-entry isotope-item post-3414 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-tech-transf\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-tech-transf-1-564x705.jpg);\"  title=\"CDMO-tech-transf\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u6280\u672f\u8f6c\u79fb<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/m-ds\/\"  id='av-masonry-1-item-46' data-av-masonry-item='46' class='av-masonry-entry isotope-item post-46 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"manu-DS\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/manu-DS-1-564x705.jpg);\"  title=\"manu-DS\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u539f\u6db2\u751f\u4ea7<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/m-dp\/\"  id='av-masonry-1-item-3386' data-av-masonry-item='3386' class='av-masonry-entry isotope-item post-3386 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services portfolio_entries-manufacturing  av-masonry-item-with-image av-grid-img' title=\"manu-DP\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/manu-DP-1-564x705.jpg);\"  title=\"manu-DP\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u5236\u5242\u751f\u4ea7<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/quality-system\/\"  id='av-masonry-1-item-3421' data-av-masonry-item='3421' class='av-masonry-entry isotope-item post-3421 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-qs\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs-564x705.jpg);\"  title=\"CDMO-qs\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u8d28\u91cf\u4f53\u7cfb<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/regulatory-cmc-support\/\"  id='av-masonry-1-item-3423' data-av-masonry-item='3423' class='av-masonry-entry isotope-item post-3423 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-reg-CMC-sup\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup-564x705.jpg);\"  title=\"CDMO-reg-CMC-sup\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u6ce8\u518c\u670d\u52a1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/project-management\/\"  id='av-masonry-1-item-3425' data-av-masonry-item='3425' class='av-masonry-entry isotope-item post-3425 portfolio type-portfolio status-publish has-post-thumbnail hentry 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