{"id":73795,"date":"2024-02-19T15:42:06","date_gmt":"2024-02-19T06:42:06","guid":{"rendered":"https:\/\/www.hamarichemicals.com\/jpn\/?page_id=73795"},"modified":"2025-04-24T15:30:18","modified_gmt":"2025-04-24T06:30:18","slug":"clinical-manufacturing","status":"publish","type":"page","link":"https:\/\/www.hamarichemicals.com\/jpn\/products\/clinical-manufacturing\/","title":{"rendered":"\u81e8\u5e8a\u8a66\u9a13\u30fb\u88fd\u9020\u7533\u8acb"},"content":{"rendered":"<h1 class=\"Title001\" id=\"clinical\">\n  <span class=\"ja\">\u81e8\u5e8a\u8a66\u9a13\u30fb\u88fd\u9020\u7533\u8acb<\/span>\u3000<span class=\"en\">clinical stage<\/span><br \/>\n<\/h1>\n<div id=\"products\" class=\"clearfix\">\n<p class=\"kyeword\">\u8c4a\u5bcc\u306a\u5b9f\u7e3e\u3067\u8cb4\u793e\u306e\u958b\u767a\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059 (2017\uff5e2021\u5e74\u5b9f\u7e3e\uff1a47\u30c6\u30fc\u30de)<\/p>\n<div class=\"box\">\n<div class=\"toc-001\">\n<div class=\"toctitle\">\n        HAMARI\u304c\u3054\u63d0\u4f9b\u3067\u304d\u308b\u30b5\u30fc\u30d3\u30b9<label><input type=\"checkbox\" checked\/><\/label>\n      <\/div>\n<ol>\n<li><a href=\"#contrandd\">\u53d7\u8a17\u7814\u7a76<\/a><\/li>\n<li><a href=\"#contmanufact\">\u53d7\u8a17\u88fd\u9020<\/a><\/li>\n<li><a href=\"#overseas\">\u6d77\u5916\u30e1\u30fc\u30ab\u30fc\u306e\u63d0\u6848<\/a><\/li>\n<li><a href=\"#qasystem\">\u4fe1\u983c\u6027\u4fdd\u8a3c\u30b7\u30b9\u30c6\u30e0<\/a><\/li>\n<li><a href=\"#dmf\">DMF\/\u7533\u8acb\u66f8\u985e\u4f5c\u6210<\/a><\/li>\n<\/ol><\/div>\n<\/p><\/div>\n<div class=\"box\">\n<h2 id=\"contrandd\">\u53d7\u8a17\u7814\u7a76<\/h2>\n<ul>\n<li>\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u3001\u30d7\u30ed\u30bb\u30b9\u6700\u9069\u5316\u306a\u3069\u3001\u3054\u8981\u671b\u306b\u5408\u308f\u305b\u3066\u304a\u5ba2\u69d8\u306e\u30c6\u30fc\u30de\u306b\u5c02\u5c5e\u3067\u5f93\u4e8b\u3059\u308b\u7814\u7a76\u54e1\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/li>\n<li>\u304a\u6253\u3061\u5408\u308f\u305b\u3092\u3057\u306a\u304c\u3089\u691c\u8a0e\u8ab2\u984c\u3084\u671f\u9593\u3092\u8abf\u6574\u3057\u3001\u30b9\u30d4\u30fc\u30c7\u30a3\u30fc\u306a\u7814\u7a76\u958b\u767a\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/li>\n<li>\u3053\u308c\u307e\u3067\u306e\u8c4a\u5bcc\u306a\u5408\u6210\u5b9f\u7e3e\u306b\u57fa\u3065\u3044\u3066\u3001\u5408\u6210\u6cd5\u3084\u5206\u6790\u6cd5\u306e\u63d0\u6848\u30fb\u691c\u8a0e\u3092\u884c\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>    <a class=\"jeff\" href=\"https:\/\/www.hamarichemicals.com\/jpn\/contact\/dlrandd\/\" target=\"_blank\">\u8cc7\u6599\u8acb\u6c42 \u53d7\u8a17\u7814\u7a76\u306e\u3054\u6848\u5185<\/a><\/p>\n<div class=\"znr01a\">\n<p>\u4f8b\uff09\u533b\u85ac\u54c1\u539f\u85ac\u306e\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u304b\u3089\u5546\u7528\u751f\u7523\u307e\u3067\u306e\u6d41\u308c<\/p>\n<p>      <img decoding=\"async\" src=\"https:\/\/www.hamarichemicals.com\/jpn\/wp-content\/uploads\/sites\/11\/2022\/01\/znr01-02b.png\" alt=\"\u4f8b\uff09\u533b\u85ac\u54c1\u539f\u85ac\u306e\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u304b\u3089\u5546\u7528\u751f\u7523\u307e\u3067\u306e\u6d41\u308c\" width=\"600\"\/>\n    <\/div>\n<\/p><\/div>\n<div class=\"box\">\n<h2 id=\"contmanufact\">\u53d7\u8a17\u88fd\u9020<\/h2>\n<ul>\n<li>\u539f\u6599\u53d7\u5165\u304b\u3089\u88fd\u9020\u8a2d\u5099\u3001\u54c1\u8cea\u7ba1\u7406\u307e\u3067GMP\u306b\u9069\u5408\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u3067\u306e\u88fd\u9020\u3092\u304a\u7d04\u675f\u3057\u307e\u3059\u3002<\/li>\n<li>40\u540d\u3092\u8d85\u3048\u308b\u6280\u8853\u30b9\u30bf\u30c3\u30d5\u300130\u540d\u3092\u8d85\u3048\u308b\u54c1\u8cea\u7ba1\u7406\u30b9\u30bf\u30c3\u30d5\u304c\u4e07\u5168\u306e\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3092\u3057\u307e\u3059\u3002<\/li>\n<li>\u8c4a\u5bcc\u306a\u6570\u91cf\u306e\u53cd\u5fdc\u6a5f\u3067\u3054\u8981\u671b\u306b\u5408\u308f\u305b\u3066\u30d5\u30ec\u30ad\u30b7\u30d6\u30eb\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002<\/li>\n<li>\u8c4a\u5bcc\u306a\u5b9f\u7e3e\u3067\u3001\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u3092\u8fc5\u901f\u306b\u884c\u3044\u307e\u3059\u3002\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u7acb\u3061\u4e0a\u3052\u3082\u304a\u4efb\u305b\u304f\u3060\u3055\u3044<\/li>\n<\/ul>\n<p>    <a class=\"jeff\" href=\"https:\/\/www.hamarichemicals.com\/jpn\/contact\/dlplant\/\" target=\"_blank\">\u8cc7\u6599\u8acb\u6c42 \u53d7\u8a17\u88fd\u9020\u306e\u3054\u6848\u5185<\/a><\/p>\n<div class=\"znr01a\">\n<p>\u4f8b1\uff09IND Project\uff08\u51685\u5de5\u7a0b\uff09<br \/>\n        GLP-API  2 \u30ed\u30c3\u30c8, GMP-API 1 \u30ed\u30c3\u30c8<\/p>\n<p>      <img decoding=\"async\" src=\"https:\/\/www.hamarichemicals.com\/jpn\/wp-content\/themes\/hamari\/products\/img\/znr02-01.gif\" alt=\"\u533b\u85ac\u54c1\u539f\u85ac IND Project (\u51685\u5de5\u7a0b)\" width=\"600\"\/><\/p>\n<p>\u4f8b2\uff09PAI project\uff08\u51687\u5de5\u7a0b\uff09<br \/>\n      Final intermediate (NDA)\u3000Pilot 2 Batch, Validation 3 Batch<\/p>\n<p>      <img decoding=\"async\" src=\"https:\/\/www.hamarichemicals.com\/jpn\/wp-content\/themes\/hamari\/products\/img\/znr02-02.gif\" alt=\"\u533b\u85ac\u54c1\u539f\u85ac PAI project (\u51687\u5de5\u7a0b)\u3000Final intermediate (NDA)\" width=\"600\"\/>\n    <\/div>\n<\/p><\/div>\n<div class=\"box\">\n<h2 id=\"overseas\">\u6d77\u5916\u30e1\u30fc\u30ab\u30fc\u306e\u63d0\u6848<\/h2>\n<p>\u3053\u3093\u306a\u3053\u3068\u3067\u304a\u56f0\u308a\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304b\u3002<\/p>\n<ol>\n<li>\u30b3\u30b9\u30c8\u3092\u4e0b\u3052\u308b\u3053\u3068\u304c\u3067\u304d\u306a\u3044<\/li>\n<li>\u6d77\u5916\u30e1\u30fc\u30ab\u30fc\u306f\u7ba1\u7406\u304c\u96e3\u3057\u305d\u3046\u2026<\/li>\n<\/ol>\n<p>HAMARI\u306a\u3089\u3001\u53d6\u5f15\u5b9f\u7e3e\u306e\u3042\u308b\u4fe1\u983c\u3067\u304d\u308b\u6d77\u5916\u4f01\u696d\u3068\u5354\u696d\u3059\u308b\u3053\u3068\u3067\u3001\u5f93\u6765\u3088\u308a\u5b89\u4fa1\u306a\u539f\u85ac\u30fb\u4e2d\u9593\u4f53\u3092\u4f9b\u7d66\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u304a\u5ba2\u69d8\u306b\u4ee3\u308f\u3063\u3066\u6d77\u5916\u88fd\u9020\u79fb\u8ee2\u3068\u305d\u306e\u5f8c\u306e\u54c1\u8cea\u7ba1\u7406\u3092\u5f15\u304d\u53d7\u3051\u307e\u3059\u3002<\/p>\n<div class=\"znr01a\">\n<table>\n<caption>\u4e3b\u306a\u53d6\u5f15\u5148<\/caption>\n<tbody>\n<tr>\n<th>\u4e2d\u56fd<\/th>\n<td>Apeloa Co., Ltd.<br \/>\n              PepTech Corporation<br \/>\n              Chemik<br \/>\n              Contech<br \/>\n              Astatech, Inc.<br \/>\n              Hubei Xunda Pharmaceutical Co., Ltd.<br \/>\n              Suzhou Tianma Speciality Chemicals Co., Ltd.\n            <\/td>\n<\/tr>\n<tr>\n<th>\u53f0\u6e7e<\/th>\n<td>FORMOSA LABORATORIES, INC.<br \/>\n              Standard Chem. &#038; Pharm. Co., Ltd.\n            <\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<h3><i class=\"cp_arrow2_green\"><\/i>PepTech<\/h3>\n<p>HAMARI\u306fPepTech\u793e\u3068\u5354\u696d\u3057\u3001\u7814\u7a76\u7528\u975e\u5929\u7136\u578b\u30a2\u30df\u30ce\u9178\u8a66\u85ac\u3084\u30da\u30d7\u30c1\u30c9\u8a66\u85ac\u306e\u8f38\u5165\u8ca9\u58f2\u304a\u3088\u3073\u30ab\u30b9\u30bf\u30e0\u5408\u6210\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<div class=\"znr01a\">\n<table>\n<caption>\u4f1a\u793e\u6982\u8981<\/caption>\n<tbody>\n<tr>\n<th>\u793e\u540d<\/th>\n<td>PepTech Corporation<\/td>\n<\/tr>\n<tr>\n<th>\u6240\u5728\u5730<\/th>\n<td>[ Headquarters ]<br \/>\n                                  Bedford, Massachusetts, USA[ R &amp; D Center ]<br \/>\n                                  Xuhui District, Shanghai, China[Metric Ton Manufacturing Plant]<br \/>\n                                  Jinshan District, Shanghai, China<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<\/p><\/div>\n<div class=\"box\">\n<h2 id=\"qasystem\">\u4fe1\u983c\u6027\u4fdd\u8a3c\u30b7\u30b9\u30c6\u30e0<\/h2>\n<p>\u4fe1\u983c\u6027\u4fdd\u8a3c\u4f53\u5236\u4e0b\u3067\u306e\u30c7\u30fc\u30bf\u53d6\u5f97\u3082\u304a\u4efb\u305b\u304f\u3060\u3055\u3044\u3002ICH Q11\u306b\u5bfe\u5fdc\u3057\u305f\u7dfb\u5bc6\u306a\u30c7\u30fc\u30bf\u53d6\u5f97\u3067\u3001\u8cb4\u793e\u306e\u3054\u8ca0\u62c5\u3092\u5927\u304d\u304f\u8efd\u6e1b\u3057\u307e\u3059\u3002<\/p>\n<h3><i class=\"cp_arrow2_green\"><\/i>\u652f\u63f4\u4e8b\u4f8b<\/h3>\n<ol>\n<li>SOP(Standard Operating Procedures\u3001\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8)\u306e\u4f5c\u6210<\/li>\n<li>\u88fd\u9020\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u8a2d\u5b9a<\/li>\n<li>\u65b0\u85ac\u306e\u7533\u8acb\u8cc7\u6599\u306e\u4f5c\u6210<\/li>\n<\/ol>\n<div class=\"znr01a\">\n<table>\n<caption>\u5b9f\u7e3e<\/caption>\n<tbody>\n<tr>\n<th>2013\u5e74<\/th>\n<td>\u539f\u85acA\u30003\u540d\u4f53\u5236\u00d71\u5e74\u9593<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<\/p><\/div>\n<div class=\"box\">\n<h2 id=\"dmf\">DMF\/\u7533\u8acb\u66f8\u985e\u4f5c\u6210<\/h2>\n<p>\u56fd\u5185\u5916\u306eDMF\u767b\u9332\u306b\u95a2\u3057\u3066\u3001\u8c4a\u5bcc\u306a\u5b9f\u7e3e\u304c\u3054\u3056\u3044\u307e\u3059\u3002<br \/>\n      \u8c4a\u5bcc\u306a\u4f5c\u6210\u5b9f\u7e3e\u3084\u6839\u62e0\u30c7\u30fc\u30bf\u53d6\u5f97\u4f53\u5236\u306b\u3088\u308a\u3001\u56fd\u5185\u5916\u306e\u65b0\u85ac\u306e\u7533\u8acb\u66f8\u985e\u4f5c\u6210\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002CTD\u306e\u4f5c\u6210\u3082\u6d5c\u7406\u306b\u304a\u4efb\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n<div class=\"znr01a\">\n<table>\n<caption>\u767b\u9332\u4ef6\u6570(2025\u5e744\u6708\u73fe\u5728)<\/caption>\n<tbody>\n<tr>\n<th>USA<\/th>\n<td>Type II<\/td>\n<td align=\"center\">1<\/td>\n<\/tr>\n<tr>\n<th>EU<\/th>\n<td>ASMF (EDMF)<\/td>\n<td align=\"center\">1<\/td>\n<\/tr>\n<tr>\n<th>Korea<\/th>\n<td>DMF<\/td>\n<td align=\"center\">2<\/td>\n<\/tr>\n<tr>\n<th>\u65e5\u672c<\/th>\n<td>MF<\/td>\n<td align=\"center\">34<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u81e8\u5e8a\u8a66\u9a13\u30fb\u88fd\u9020\u7533\u8acb\u3000clinical stage \u8c4a\u5bcc\u306a\u5b9f\u7e3e\u3067\u8cb4\u793e\u306e\u958b\u767a\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059 (2017\uff5e2021\u5e74\u5b9f\u7e3e\uff1a47\u30c6\u30fc\u30de) HAMARI\u304c\u3054\u63d0\u4f9b\u3067\u304d\u308b\u30b5\u30fc\u30d3\u30b9 \u53d7\u8a17\u7814\u7a76 \u53d7\u8a17\u88fd\u9020 \u6d77\u5916\u30e1\u30fc\u30ab\u30fc\u306e\u63d0\u6848 \u4fe1\u983c\u6027\u4fdd\u8a3c\u30b7\u30b9\u30c6\u30e0 DMF\/\u7533\u8acb\u66f8\u985e\u4f5c\u6210 \u53d7\u8a17\u7814\u7a76 \u30d7\u30ed\u30bb\u30b9\u958b\u767a\u3001\u30d7\u30ed\u30bb\u30b9\u6700\u9069\u5316\u306a\u3069\u3001\u3054\u8981\u671b\u306b\u5408\u308f\u305b\u3066\u304a\u5ba2\u69d8\u306e\u30c6\u30fc\u30de\u306b\u5c02\u5c5e\u3067\u5f93\u4e8b\u3059\u308b\u7814\u7a76\u54e1\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002 \u304a\u6253\u3061\u5408\u308f\u305b\u3092\u3057\u306a\u304c\u3089\u691c\u8a0e\u8ab2\u984c\u3084\u671f\u9593\u3092\u8abf\u6574\u3057\u3001\u30b9\u30d4\u30fc\u30c7\u30a3\u30fc\u306a\u7814\u7a76\u958b\u767a\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002 \u3053\u308c\u307e\u3067\u306e\u8c4a\u5bcc\u306a\u5408\u6210\u5b9f\u7e3e\u306b\u57fa\u3065\u3044\u3066\u3001\u5408\u6210\u6cd5\u3084\u5206\u6790\u6cd5\u306e\u63d0\u6848\u30fb\u691c\u8a0e\u3092\u884c\u3044\u307e\u3059\u3002 \u8cc7\u6599\u8acb\u6c42 \u53d7\u8a17\u7814\u7a76\u306e\u3054\u6848\u5185 \u4f8b\uff09\u533b\u85ac\u54c1\u539f\u85ac\u306e\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u304b\u3089\u5546\u7528\u751f\u7523\u307e\u3067\u306e<a 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