{"id":16491,"date":"2025-12-02T09:02:01","date_gmt":"2025-12-02T00:02:01","guid":{"rendered":"https:\/\/www.emukk.com\/WP\/?page_id=16491"},"modified":"2025-12-02T10:42:04","modified_gmt":"2025-12-02T01:42:04","slug":"%e3%83%90%e3%82%a4%e3%82%aa%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e7%b3%96%e9%8e%96%e8%a7%a3%e6%9e%90%ef%bc%9a%e6%8a%97%e4%bd%93%e5%8c%bb%e8%96%ac%e5%93%81%e8%a9%95%e4%be%a1%e7%94%a8%e3%81%a8%e3%81%97","status":"publish","type":"page","link":"https:\/\/www.emukk.com\/WP\/%e3%83%90%e3%82%a4%e3%82%aa%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e7%b3%96%e9%8e%96%e8%a7%a3%e6%9e%90%ef%bc%9a%e6%8a%97%e4%bd%93%e5%8c%bb%e8%96%ac%e5%93%81%e8%a9%95%e4%be%a1%e7%94%a8%e3%81%a8%e3%81%97\/","title":{"rendered":"\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u7cd6\u9396\u89e3\u6790\uff1a\u6297\u4f53\u533b\u85ac\u54c1\u8a55\u4fa1\u7528\u3068\u3057\u3066\u30ab\u30b9\u30bf\u30e0\u8a2d\u8a08\u3055\u308c\u305f\u30ec\u30af\u30c1\u30f3\u30a2\u30ec\u30a4\uff08IgG1-mAb-LecChip\uff09\u306e\u6709\u7528\u6027"},"content":{"rendered":"<p>\u4e16\u754c\u306e\u533b\u85ac\u54c1\u5168\u4f53\u306e\u30de\u30fc\u30b1\u30c3\u30c8\u30b5\u30a4\u30ba\u306f2024\u5e74\u306b\u7d04262\u5146\u5186\u306b\u9054\u3057\u305f\u3068\u306e\u3053\u3068\u3067\u3059\u3002<a href=\"https:\/\/www.mizuho-rt.co.jp\/business\/consulting\/articles\/2023-k0038\/index.html\">\u305d\u306e\u4e2d\u3067\u3082\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u6210\u9577\u306f\u9855\u8457\u3067\u3042\u308a\u3001\u540c\u5e74\u306b\u306f\u305d\u306e\u30de\u30fc\u30b1\u30c3\u30c8\u30b5\u30a4\u30ba\u306f38\u5146\u5186\u306b\u9054\u3057\u3001\u4eca\u5f8c\u308210%\u3092\u8d85\u3048\u308b\u6210\u9577\u7387\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u66f4\u306b\u3001\u4e16\u754c\u58f2\u4e0a\u9ad8\u306e\u4e0a\u4f4d100\u4f4d\u306e\u533b\u85ac\u54c1\u306b\u7d5e\u308b\u3068\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u5360\u3081\u308b\u5272\u5408\u306f2019\u5e74\u306b\u306f5\u5272\u4ee5\u4e0a\u3092\u5360\u3081\u308b\u307e\u3067\u306b\u306a\u3063\u3066\u3044\u307e\u3059<\/a>\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u72b6\u6cc1\u3092\u898b\u8d8a\u3057\u305f\u3088\u3046\u306b\u30012011\u5e74\u306b\u306f\u3001FDA\u306b\u6cbb\u7642\u7528\u30bf\u30f3\u30d1\u30af\u8cea\u306eQC\u306b\u95a2\u3059\u308b\u7279\u5225\u30c1\u30fc\u30e0\u304cDr. 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Ver1.0\u3092\u7528\u3044\u305f\u6297\u4f53\u533b\u85ac\u54c1\u306e\u8a55\u4fa1\u7d50\u679c\u304c\u3001FDA\u3088\u308a\uff12\u672c\u306e\u8ad6\u6587\u3068\u3057\u3066\u516c\u958b\u3055\u308c\u307e\u3057\u305f\u3002<br \/>\n<a href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/19420862.2015.1117719\">Glycan analysis of therapeutic glycoproteins<\/a><br \/>\n<a href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/19420862.2016.1149662\">The use of lectin microarray for assessing glycosylation of therapeutic proteins<\/a><br \/>\n\u3053\u308c\u3089\u306e\u8ad6\u6587\u306b\u304a\u3044\u3066\u3001FDA\u306f\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u3092\u7528\u3044\u305f\u6297\u4f53\u533b\u85ac\u54c1\u306e\u8a55\u4fa1\u306b\u5bfe\u3057\u3066\u3001\u305d\u306e\u512a\u4f4d\u6027\u3092\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u300c\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u306f\u3001\u9175\u7d20\u6d88\u5316\u3092\u7528\u3044\u3066\u306e\u30bf\u30f3\u30d1\u30af\u8cea\u9aa8\u683c\u304b\u3089\u306e\u7cd6\u9396\u306e\u5207\u308a\u53d6\u308a\u3092\u5fc5\u8981\u3068\u305b\u305a\u3001\u30bf\u30f3\u30d1\u30af\u8cea\u304c\u6301\u3064\u7cd6\u9396\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u305d\u306e\u307e\u307e\u76f4\u63a5\u7684\u306b\u6e2c\u5b9a\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u7cd6\u9396\u89e3\u6790\u306b\u5bfe\u3059\u308b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u6280\u8853\u306f\u3001\u7cd6\u30bf\u30f3\u30d1\u30af\u8cea\u304c\u6301\u3064\u7cd6\u9396\u30d0\u30ea\u30a2\u30f3\u30c8\u3092\u5b8c\u5168\u306b\u30ab\u30d0\u30fc\u3059\u308b\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u308b\u3068\u3044\u3046\u70b9\u3067\u72ec\u7279\u3067\u3059\u3002\u5e02\u8ca9\u306e\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\uff08LecChip 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\/>\n\u300c\u672c\u7814\u7a76\u3067\u4f7f\u7528\u3057\u305f\u5e02\u8ca9\u306e\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u306f\u3001\u6cbb\u7642\u7528\u6297\u4f53\u533b\u85ac\u54c1\u306e\u8a55\u4fa1\u5c02\u7528\u306b\u8a2d\u8a08\u3055\u308c\u305f\u3082\u306e\u3067\u306f\u306a\u3044\u3002\u539f\u7406\u7684\u306b\u306f\u3001\u7570\u306a\u308b\u7cd6\u9396\u69cb\u9020\u306b\u5bfe\u3059\u308b\u9078\u629e\u6027\u3068\u7d50\u5408\u89aa\u548c\u6027\u3092\u9ad8\u3081\u305f\u30ec\u30af\u30c1\u30f3\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u8a55\u4fa1\u6027\u80fd\u3092\u3055\u3089\u306b\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u7279\u5b9a\u306e\u7cd6\u30bf\u30f3\u30d1\u30af\u8cea\u3092\u5206\u6790\u3059\u308b\u305f\u3081\u306b\u3001\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u306f\u3001\u8a66\u9a13\u30b5\u30f3\u30d7\u30eb\u4e2d\u306b\u5b58\u5728\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u7cd6\u9396\u69cb\u9020\u306b\u95a2\u9023\u3059\u308b\u30ec\u30af\u30c1\u30f3\u3092\u542b\u3080\u3088\u3046\u306b\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u308b\u3002\u3053\u306e\u3088\u3046\u306b\u3057\u3066\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u3092\u6700\u9069\u5316\u3059\u308c\u3070\u3001\u3053\u306e\u7cd6\u9396\u89e3\u6790\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\uff08GlycoStation\uff09\u306f\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u7cd6\u9396\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u30cf\u30a4\u30b9\u30eb\u30fc\u30d7\u30c3\u30c8\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306e\u305f\u3081\u306e\u6709\u7528\u306a\u30c4\u30fc\u30eb\u3068\u3057\u3066\u63a1\u7528\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u300d<\/p>\n<p>\u3053\u306e\u7d50\u8ad6\u3092\u8e0f\u307e\u3048\u3066\u3001FDA\u306f\u3001\u30b0\u30e9\u30a4\u30b3\u30c6\u30af\u30cb\u30ab\u304c\u5f53\u6642\u4f7f\u7528\u3057\u3066\u3044\u305f\u5929\u7136\u578b\u30ec\u30af\u30c1\u30f3\u304a\u3088\u3073\u30ea\u30b3\u30f3\u30d3\u30ca\u30f3\u30c8\u30ec\u30af\u30c1\u30f3\u3001\u305d\u306e\u7dcf\u657083\u7a2e\u985e\u3001\u3092\u7528\u3044\u3066\u6cbb\u7642\u7528\u6297\u4f53\u533b\u85ac\u54c1\u8a55\u4fa1\u7528\u306e\u30ab\u30b9\u30bf\u30e0\u30ec\u30af\u30c1\u30f3\u30de\u30a4\u30af\u30ed\u30a2\u30ec\u30a4\u306e\u958b\u767a\u3092\u9032\u3081\u307e\u3057\u305f\u3002\u305d\u306e\u7d50\u679c\u306f\u30012024\u5e74\u306b\u4ee5\u4e0b\u306e\uff12\u8ad6\u6587\u3068\u3057\u3066\u516c\u958b\u3055\u308c\u307e\u3057\u305f\u3002<br \/>\n<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s11095-023-03628-4\">Benchmark Glycan Profile of Therapeutic Monoclonal Antibodies Produced by Mammalian Cell Expression Systems<\/a><br \/>\n<a href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/19420862.2024.2304268\">A tailored lectin microarray for rapid glycan profiling of therapeutic monoclonal antibodies<\/a><\/p>\n<p>\u3053\u306e\u7814\u7a76\u958b\u767a\u3067\u4f7f\u7528\u3055\u308c\u305f\u30ec\u30af\u30c1\u30f3\u306f\u3001\u3061\u306a\u307f\u306b\u4e0b\u8a18\u3067\u3042\u308a\u307e\u3059\u3002<br \/>\n<a href=\"https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2022\/10\/Lectin-Microarray-Ver1.0-Specificity.pdf\">LecChip Ver1.0<\/a><br \/>\n<a href=\"https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2022\/11\/Lectin-Microarray-Ver2.0-Specificity.pdf\">LecChip Ver2.0<\/a><\/p>\n<p>FDA\u306f\u3001\u6297\u4f53\u533b\u85ac\u54c1\u3068\u3057\u3066\u8a8d\u53ef\u3057\u305f157\u7a2e\u985e\u306e\u6297\u4f53\u533b\u85ac\u54c1\u306e\u7cd6\u9396\u4fee\u98fe\u69cb\u9020\u3092\u7db2\u7f85\u7684\u306b\u89e3\u6790\u3057\u3001\u4e00\u822c\u7684\u306b\u5b58\u5728\u3059\u308b9\u3064\u306e\u7cd6\u9396\u30a8\u30d4\u30c8\u30fc\u30d7\u3092\u767a\u898b\u30fb\u540c\u5b9a\u3057\u307e\u3057\u305f\u30029\u3064\u306e\u7cd6\u9396\u30a8\u30d4\u30c8\u30fc\u30d7\u3068\u306f\u3001core fucose, terminal N-acetylglucosamine, terminal \u03b2-galactose, high mannose, terminal \u03b12,3-linked N-acetylneuraminic acid, terminal \u03b12,6-linked N-glycolylneuraminic acid, bisecting N-acetylglucosamine, terminal \u03b1-galactose, triantennary 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PHAL\u3067\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u30ec\u30af\u30c1\u30f3\u30a2\u30ec\u30a4\u306f\u3001\u6297\u4f53\u533b\u85ac\u54c1\u30b5\u30f3\u30d7\u30eb\u304b\u3089\u7cd6\u9396\u3092\u5207\u308a\u51fa\u3059\u3053\u3068\u306a\u304f\u305d\u306e\u307e\u307e\u5229\u7528\u3059\u308b\u3053\u3068\u304c\u51fa\u6765\u3001\u8fc5\u901f\u306a\u7cd6\u9396\u30d7\u30ed\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u306e\u305f\u3081\u306e\u30cf\u30a4\u30b9\u30eb\u30fc\u30d7\u30c3\u30c8\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u63d0\u4f9b\u3057\u3001\u9ad8\u7cbe\u5ea6\u306a\u7cd6\u9396\u4fee\u98fe\u30d1\u30bf\u30fc\u30f3\u306e\u6bd4\u8f03\u5206\u6790\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<br \/>\n\u300cFDA\u306f\u3001\u3053\u306e\u30ec\u30af\u30c1\u30f3\u30a2\u30ec\u30a4\u304c\u3001\u69d8\u3005\u306a\u88fd\u9020\u30d0\u30c3\u30c1\u9593\u3001\u3042\u308b\u3044\u306f\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3068\u5148\u767a\u533b\u85ac\u54c1\u9593\u306e\u7cd6\u9396\u4fee\u98fe\u306e\u9055\u3044\u3092\u8a55\u4fa1\u3059\u308b\u4e0a\u3067\u6975\u3081\u3066\u5b9f\u7528\u7684\u3067\u3042\u308b\u3068\u7d50\u8ad6\u3057\u307e\u3057\u305f\u3002\u300d\u306a\u304a\u3001\u3053\u306eIgG1-mAb-LecChip\u306b\u306f\u300114\u500b\u306e\u30a6\u30a8\u30eb\u304c\u5b58\u5728\u3057\u3001\u305d\u308c\u305e\u308c\u306e\u30a6\u30a7\u30eb\u5185\u306b9\u3064\u306e\u30ec\u30af\u30c1\u30f3\u304c3\u91cd\u306b\u30b9\u30dd\u30c3\u30c6\u30a3\u30f3\u30b0\u3055\u308c\u3066\u3044\u307e\u3059\u300214\u7a2e\u985e\u306e\u30b5\u30f3\u30d7\u30eb\u3092\u540c\u6642\u306b\u6bd4\u8f03\u7cd6\u9396\u30d7\u30ed\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u89e3\u6790\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002<\/p>\n<p><a href=\"https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-large wp-image-16494\" src=\"https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip-1024x464.png\" alt=\"\" width=\"696\" height=\"315\" srcset=\"https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip-1024x464.png 1024w, https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip-300x136.png 300w, https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip-768x348.png 768w, https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip-1536x697.png 1536w, https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip-600x272.png 600w, https:\/\/www.emukk.com\/WP\/wp-content\/uploads\/2025\/12\/FDA-LecChip.png 1903w\" sizes=\"auto, (max-width: 696px) 100vw, 696px\" \/><\/a><br \/>\n<a href=\"https:\/\/www.fda.gov\/drugs\/regulatory-science-action\/novel-method-rapid-glycan-profiling-therapeutic-monoclonal-antibodies\">FDA\u306e\u30db\u30fc\u30e0\u30da\u30fc\u30b8\u3088\u308a\u5f15\u7528<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e16\u754c\u306e\u533b\u85ac\u54c1\u5168\u4f53\u306e\u30de\u30fc\u30b1\u30c3\u30c8\u30b5\u30a4\u30ba\u306f2024\u5e74\u306b\u7d04262\u5146\u5186\u306b\u9054\u3057\u305f\u3068\u306e\u3053\u3068\u3067\u3059\u3002\u305d\u306e\u4e2d\u3067\u3082\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u6210\u9577\u306f\u9855\u8457\u3067\u3042\u308a\u3001\u540c\u5e74\u306b\u306f\u305d\u306e\u30de\u30fc\u30b1\u30c3\u30c8\u30b5\u30a4\u30ba\u306f38\u5146\u5186\u306b\u9054\u3057\u3001\u4eca\u5f8c\u308210%\u3092\u8d85\u3048\u308b\u6210\u9577\u7387\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u66f4\u306b<\/p><\/div>\n<div class=\"blog-btn\"><a 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