{"id":4725,"date":"2021-10-15T10:05:20","date_gmt":"2021-10-15T02:05:20","guid":{"rendered":"https:\/\/chimebiologics.com\/?p=4725"},"modified":"2025-06-16T18:48:57","modified_gmt":"2025-06-16T10:48:57","slug":"chime-biologics-announces-a-cooperation-with-cytiva-on-gmp-2-project","status":"publish","type":"post","link":"https:\/\/chimebiologics.com\/ja\/chime-biologics-announces-a-cooperation-with-cytiva-on-gmp-2-project\/","title":{"rendered":"(English) Chime Biologics Announces a Cooperation with Cytiva on GMP-2 Project"},"content":{"rendered":"<p class=\"qtranxs-available-languages-message qtranxs-available-languages-message-ja\">\u7533\u3057\u8a33\u3042\u308a\u307e\u305b\u3093\u3001\u3053\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u306f\u305f\u3060\u4eca\u3000<a href=\"https:\/\/chimebiologics.com\/en\/wp-json\/wp\/v2\/posts\/4725\" class=\"qtranxs-available-language-link qtranxs-available-language-link-en\" title=\"English\">English<\/a>\u3068 <a href=\"https:\/\/chimebiologics.com\/zh\/wp-json\/wp\/v2\/posts\/4725\" class=\"qtranxs-available-language-link qtranxs-available-language-link-zh\" title=\"\u4e2d\u6587\">\u4e2d\u6587<\/a>\u3000\u306e\u307f\u3067\u3059\u3002 For the sake of viewer convenience, the content is shown below in this site default language. You may click one of the links to switch the site language to another available language.<\/p><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8\">\n.flex_column.av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8{\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-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8 av_two_third  avia-builder-el-0  el_before_av_two_third  avia-builder-el-first  first flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-k6j2pxor-09272cddfdcc1afe6211303b3b3d55e0'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><span style=\"color: #000000;\"><\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_two_third-1e26125d131ba13f1accaa8241be1528\">\n.flex_column.av-av_two_third-1e26125d131ba13f1accaa8241be1528{\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-av_two_third-1e26125d131ba13f1accaa8241be1528 av_two_third  avia-builder-el-2  el_after_av_two_third  el_before_av_one_third  first flex_column_div av-zero-column-padding column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2d3l4o-9301d0cdc14489efa114080353995aa9\">\n.flex_column.av-2d3l4o-9301d0cdc14489efa114080353995aa9{\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-2d3l4o-9301d0cdc14489efa114080353995aa9 av_one_third  avia-builder-el-3  el_after_av_two_third  el_before_av_one_full  flex_column_div av-zero-column-padding column-top-margin'     ><\/div><\/p>\n<div class='flex_column av-av_one_full-7714eba142aeda1f8b5272a3c372b279 av_one_full  avia-builder-el-4  el_after_av_one_third  avia-builder-el-last  first flex_column_div column-top-margin'     ><section  class='av_textblock_section av-mbu5t65g-73d6972d4daa685342dff6fd56a9c730'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><\/p>\n<h1><strong>Chime Biologics Announces a Cooperation with Cytiva on GMP-2 Project<\/strong><\/h1>\n<ul>\n<li><strong>Chime Biologics has agreed with Cytiva,<\/strong> <strong>a globally advanced and modular biopharmaceutical factory that sets international standards, to obtain process equipment, personnel training, as well as manufacturing materials and consumables for the GMP-2 expansion project from Cytiva.<\/strong><\/li>\n<li><strong>At GMP-1 Project with the KUBio Plant of Cytiva, Chime Biologics has completed the GMP manufacturing of 70+ batches of drug substances.<\/strong><\/li>\n<li><strong>Cytiva will help Chime Biologics to complete the commercial manufacturing of COVID-19 therapeutic antibody for Humanigen, Inc. (hereinafter referred to as \"Humanigen\") with the <\/strong><strong>industry-leading modular disposable biopharmaceutical factory (KUBio).<\/strong><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><strong>October 15, 2021<\/strong>, Chime Biologics reached an agreement with Cytiva, a global life science pioneer, to obtain a total solution for the GMP-2 expansion project. Through the second cooperation between the two following the cooperation on KUBio, a modular biopharmaceutical factory, in 2016, Cytiva will provide support for Chime regarding process equipment, personnel training, supply of manufacturing materials and consumables to continually drive the development of the CDMO. As another milestone, the collaboration fully demonstrates the two companies' vision to serve the biopharmaceutical enterprises together through continuous and in-depth cooperation, integrating of each other's advantages.<\/span><\/p>\n<p><span style=\"color: #000000;\">Chime Biologics has completed the GMP manufacturing of more than 70 batches of drug substance with Cytiva's total modular biopharmaceutical solution KUBio, proving the stable manufacturing capacity of the solution that balances flexibility and efficiency, as well as our comprehensive quality management system and safe manufacturing standards. As a global advanced and modular biopharmaceutical plant in line with international standards, the factory complies with ICH, FDA, EMA and NMPA standards, has been granted a Drug Manufacturing Certificate by the Drug Administration of Hubei Province, and has passed the ISO14001:2015 and ISO45001:2018 certifications internationally. With the advanced equipment, internationally renowned expert team, and standardized management system, this will be a lasting driving force for the vigorous development of China\u2019s biopharmaceutical industry.<\/span><\/p>\n<p><span style=\"color: #000000;\">As an innovative \"turnkey project\" biopharmaceutical solution applied with advanced technology and ready-to-use bioprocess facilities in the industry, KUBio greatly reduces the project construction time and cost, facilitates to accelerate the development of biopharmaceutical industry in China through the advanced process and manufacturing flexibility in line with international cGMP standards. Taking the KUBio of Chime Biologics as an example, it consists of 62 modules and took only 18 months from manufacturing to assembly, which is far less than the time required for the construction of a traditional plant, thus helping Chime Biologics accelerate the manufacturing and marketing of biopharmaceuticals.<\/span><\/p>\n<p><span style=\"color: #000000;\">The process and manufacturing capacity of KUBio have also been recognized by Humanigen, a US-based biopharmaceutical company. Humanigen has entrusted us to manufacture the drug substance and finished product of its lenzilumab, a candidate for the treatment of immune overreaction known as \"cytokine storm\". It will be marketed in Europe, UK, India and Brazil after regulatory approval and obtaining the marketing authorization. As the first overseas CDMO partner of Humanigen, we promise to provide at least a capacity of 56,000 liters per year for Humanigen.<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Yu Lihua, General Manager of China, Cytiva<\/strong>, said, \"China's biopharmaceutical industry is growing at a rapid pace, and it has become an increasingly important part of the global supply chain. Cytiva is committed to enabling the sustainable development balancing flexibility and stability for local industrial chain through advanced biopharmaceutical processes. The partnership with Chime Biologics also embodies Cytiva\u2019s philosophy of \u00a0\u2018In China, for China\u2019. In the future, Cytiva will continue to provide Chinese customers, including Chime Biologics, with more diversified technology and equipment to assist in all the links of biopharmaceutical industry.\"<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>About Cytiva<\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\">At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 16 000 associates in more than 40 countries, we're driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers.\u202f Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com.<\/span><\/p>\n<p><strong>About Chime Biologics<\/strong><\/p>\n<p>Chime Biologics is a global leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health.\u00a0 For more information, please visit www.chimebiologics.com.<\/p>\n<p><span style=\"color: #000000;\"><\/span><\/p>\n<\/div><\/section><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":19,"featured_media":6582,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,52],"tags":[],"class_list":["post-4725","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-corporate-news","category-news"],"_links":{"self":[{"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/posts\/4725","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/comments?post=4725"}],"version-history":[{"count":12,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/posts\/4725\/revisions"}],"predecessor-version":[{"id":8752,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/posts\/4725\/revisions\/8752"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/media\/6582"}],"wp:attachment":[{"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/media?parent=4725"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/categories?post=4725"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/chimebiologics.com\/ja\/wp-json\/wp\/v2\/tags?post=4725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}