{"id":80,"date":"2023-09-19T17:17:27","date_gmt":"2023-09-19T08:17:27","guid":{"rendered":"http:\/\/www.lifescience.shokubai.co.jp\/home\/service01\/"},"modified":"2025-11-13T13:07:57","modified_gmt":"2025-11-13T04:07:57","slug":"cdmo","status":"publish","type":"page","link":"https:\/\/www.lifescience.shokubai.co.jp\/en\/cdmo\/","title":{"rendered":"Contract Manufacturing of Oligonucleotide &amp; Peptide APIs"},"content":{"rendered":"\n<section class=\"service01_contents_01 service_page_contents inner-container\">\n  <h2 class=\"lower_contents_title\">From Exploratory Research to Commercial Manufacturing<\/h2>\n  <p class=\"lower_contents_summary\">\n    In the oligonucleotide and peptide API manufacturing business, we respond to customer needs in each stage, from small-scale synthesis for drug efficacy and toxicity evaluation to contract research on processing and method development for pilot manufacturing and GMP-compliant API manufacturing.\n  <\/p>\n\n  <div class=\"imgContent js-scrollable\">\n    <picture class=\"imgBox\">\n      <source srcset=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service_en\/service01_img01.webp\" type=\"image\/webp\">\n      <img decoding=\"async\" src=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service_en\/service01_img01.png\" alt=\"\">\n    <\/picture>\n  <\/div><!-- \/.imgContent -->\n\n  <p class=\"lower_contents_summary\">\n   Services from the exploratory stage to the non-clinical stage are provided in the Pharmaceuticals Synthesis Laboratory, and services from the clinical stage to the commercial stage are provided in the GMP facility.<br>\n\nWe have two manufacturing lines for the synthesis and purification of oligonucleotides, and one manufacturing line for peptides, which makes us one of the largest manufacturer of oligonucleotide and peptide APIs in Japan.\n  <\/p>\n<\/section><!-- \/.service01_contents_01 -->\n\n\n\n<section class=\"service01_contents_02 service_page_contents inner-container\">\n  <dl>\n    <dt>Laboratory (non-GMP)<\/dt>\n     <dd>Cytiva<span>\u00c4KTA&trade; oligopilot plus 100<\/span><\/dd>\n     <dd>Cytiva<span>\u00c4KTA pure&trade; 150<\/span><\/dd>\n     <dd>Cytiva<span>\u00c4KTA&trade; avant 150<\/span><\/dd>\n     <dd>Small-scale Oligonucleotide synthesizer<\/dd>\n     <dd>Small-scale Peptide synthesizer<\/dd>\n     <dd>Ultrafiltration equipment<\/dd>\n     <dd>Lyophilizer<\/dd>\n  <\/dl>\n\n  <dl>\n    <dt>GMP Facility<\/dt>\n    <dd>Cytiva OligoPilot&trade; 400<\/dd>\n    <dd>Peptide synthesizer (30L\uff09<\/dd>\n    <dd>Low pressure purification system <span>Column diameter: 100\u339c, 200mm<\/span><\/dd>\n    <dd>High pressure purification system <span>Column diameter: 200\u339c, 450mm<\/span><\/dd>\n    <dd>Ultrafiltration equipment<\/dd>\n    <dd>Lyophilizer<\/dd>\n  <\/dl>\n\n  <dl>\n    <dt>Quality control laboratory<\/dt>\n   UHPLC\n    <dd>Waters ACQUITY UPLC H-Class Bio<\/dd><BR>\n    Off-line 2D-LC\n    <dd>Thermo Fisher Scientific UltiMate 3000<\/dd><BR>\n    High Resolution Mass Spectrometer (HRMS)\n    <dd>Thermo Fisher Scientific Q Exactive<\/dd>\n    <dd>Thermo Fisher Orbitrap Exploris MX<\/dd><BR><BR>\n    <font size=\"0.8em\">This Table includes trademarks of Cytiva, Waters, and Thermo Fisher.<\/font>\n  <\/dl>\n<\/section><!-- \/.service01_contents_02 -->\n\n\n\n<section class=\"service01_contents_03 service_page_contents inner-container\">\n  <ul>\n    <li>\n      <picture class=\"imgBox\">\n        <source srcset=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service\/service01_img2.webp\" type=\"image\/webp\">\n        <img decoding=\"async\" src=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/tservice\/service01_img2.png\" alt=\"Oligonucleotide API synthesis\">\n      <\/picture>\n     <h3 class=\"lower_contents_title\">Oligonucleotide API manufacturing<\/h3>\n     <div class=\"btnBox\">\n      <a href=\"https:\/\/www.lifescience.shokubai.co.jp\/en\/cdmo\/oligonucleotide\/\" class=\"btn_01 btn_01_b\">VIEW MORE<\/a>\n    <\/div>\n    <\/li>\n    <li>\n      <picture class=\"imgBox\">\n        <source srcset=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service\/service01_img3.webp\" type=\"image\/webp\">\n        <img decoding=\"async\" src=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service\/service01_img3.png\" alt=\"Oligonucleotide API synthesis\">\n      <\/picture>\n     <h3 class=\"lower_contents_title\">Peptide API manufacturing<\/h3>\n     <div class=\"btnBox\">\n      <a href=\"https:\/\/www.lifescience.shokubai.co.jp\/en\/cdmo\/peptide\/\" class=\"btn_01 btn_01_b\">VIEW MORE<\/a>\n    <\/div>\n    <\/li>\n  <\/ul>\n\n<\/section><!-- \/.service01_contents_03 -->\n\n\n\n<section class=\"service01_contents_04 service_page_contents inner-container\" id='qa'>\n  <h2 class=\"lower_contents_head\">Quality Assurance<\/h2>\n  <h3 class=\"lower_contents_title\">We provide high quality GMP-compliant APIs. <\/h3>\n  <p class=\"lower_contents_summary mb_0\">\n  GMP (Good Manufacturing Practice) is the standard for quality control and manufacturing control of pharmaceutical products.\n  <\/p>\n   \n    <p class=\"lower_contents_summary mb_0\">\n     We have established GMP-compliant SOPs (standard operation procedures) and provide education and training to all employees involved in our pharmaceutical manufacturing to ensure GMP standards.\n    <\/p>\n\n    <h3 class=\"lower_contents_title\">Quality Management System<\/h3>\n    <p class=\"lower_contents_summary mb_50\">\n      We have implemented a quality management system required for pharmaceutical products and established our quality policy and quality goals. \u2028Based on the quality policy, we set quality goals for each fiscal year, and our GMP activities are reviewed by senior management in the GMP Committee twice a year (a management review) to ensure the continuous delivery of quality products.\n    <\/p>\n\n    <div class=\"detail_list\">\n      <dl>\n        <dt class=\"lower_contents_title\">Quality Policy*<\/dt>\n\n        <dd>\u30fbWe provide quality APIs for clinical trials to obtain the trust and satisfaction of our customers.<\/dd>\n        <dd>\u30fbWe make continuous improvements to ensure the steady supply and higher quality of APIs for clinical trials.<\/dd>\n        <dd>*We plan to obtain a pharmaceutical manufacturing license in the future.<\/dd>\n         \n      <\/dl>\n      <dl>\n        <dt class=\"lower_contents_title\">Our declaration on Data Integrity<\/dt>\n        <dd>As a CDMO involved in drug development, one way we are committed to patients is by ensuring data integrity (completeness, consistency, and accuracy of data).<\/dd>\n      <\/dl>\n      \n    <\/div><!-- \/.detail_list -->\n\n    <div class=\"imgContent js-scrollable\">\n      <picture class=\"imgBox\">\n        <source srcset=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service_en\/service01_img02.webp\" type=\"image\/webp\">\n        <img decoding=\"async\" src=\"https:\/\/www.lifescience.shokubai.co.jp\/home\/wp-content\/themes\/nipponshokubai\/img\/service_en\/service01_img02.png\" alt=\"\">\n      <\/picture>\n     \n    <\/div><!-- \/.imgContent -->\n\n    <h3 class=\"lower_contents_title \">TOPICS<\/h3>\n    <p class=\"lower_contents_summary\">\n    (1) Preventing cross-contamination<br>\nOne of the requirements for a GMP facility is the prevention of contamination.\nWe have set three cleanliness levels for the manufacturing areas of our GMP facility, with ISO class 7 (during non-working time) being the highest.  <br><br>\n\nTo prevent unwanted mixing of products and contamination by foreign contaminants, the transfer routes of personnel, materials and equipment have been cafefully designed. For example, changing rooms and airlocks are properly installed for personnel, and pass-rooms are properly installed for materials and equipment. In addition, appropriately designed multiple air conditioning systems were installed according to manufacturing lines and cleanliness classes, so that the pressure difference between different cleanliness classes are properly maintained.\n    <\/p>\n    <p class=\"lower_contents_summary\">\n      (2)Ensuring safety<br>\nBased on our company motto of &#8220;safety precedes production,&#8221; we conduct decomposition calorimetry, reaction heat measurements, and chemical engineering simulations to ensure safe manufacturing. We have also strictly implemented explosion-proof measures.\n    <\/p>\n<\/section><!-- \/.service01_contents_04 -->\n","protected":false},"excerpt":{"rendered":"<p>From Exploratory Research to Commercial Manufacturing In the oligonucleotide and peptide API manufacturing business, we respond to customer needs in each stage, from small-scale synthesis for drug efficacy and toxicity evaluation to contract research on processing and method development for pilot manufacturing and GMP-compliant API manufacturing. Services from the exploratory stage to the non-clinical stage [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":7,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-80","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/pages\/80","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/comments?post=80"}],"version-history":[{"count":0,"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/pages\/80\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.lifescience.shokubai.co.jp\/en\/wp-json\/wp\/v2\/media?parent=80"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}