{"id":28137,"date":"2024-01-23T08:46:04","date_gmt":"2024-01-23T07:46:04","guid":{"rendered":"https:\/\/kymos.com\/news\/%eb%b6%88%ec%88%9c%eb%ac%bc-%ed%94%84%eb%a1%9c%ed%8c%8c%ec%9d%bc%eb%a7%81-%ec%9d%98%ec%95%bd%ed%92%88%ec%9d%98-%ec%95%8c%eb%a0%a4%ec%a7%80%ec%a7%80-%ec%95%8a%ec%9d%80-%eb%b6%88%ec%88%9c%eb%ac%bc\/"},"modified":"2024-01-23T08:46:04","modified_gmt":"2024-01-23T07:46:04","slug":"%eb%b6%88%ec%88%9c%eb%ac%bc-%ed%94%84%eb%a1%9c%ed%8c%8c%ec%9d%bc%eb%a7%81-%ec%9d%98%ec%95%bd%ed%92%88%ec%9d%98-%ec%95%8c%eb%a0%a4%ec%a7%80%ec%a7%80-%ec%95%8a%ec%9d%80-%eb%b6%88%ec%88%9c%eb%ac%bc","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%eb%b6%88%ec%88%9c%eb%ac%bc-%ed%94%84%eb%a1%9c%ed%8c%8c%ec%9d%bc%eb%a7%81-%ec%9d%98%ec%95%bd%ed%92%88%ec%9d%98-%ec%95%8c%eb%a0%a4%ec%a7%80%ec%a7%80-%ec%95%8a%ec%9d%80-%eb%b6%88%ec%88%9c%eb%ac%bc\/","title":{"rendered":"\ubd88\uc21c\ubb3c \ud504\ub85c\ud30c\uc77c\ub9c1: \uc758\uc57d\ud488\uc758 \uc54c\ub824\uc9c0\uc9c0 \uc54a\uc740 \ubd88\uc21c\ubb3c \ud2b9\uc131 \ubd84\uc11d"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">\uc758\uc57d\ud488 \ubc0f \uc758\uc57d\ud488\uc5d0\uc11c \ubc1c\uacac\ub418\ub294 \ubbf8\uc9c0\uc758 \ubd88\uc21c\ubb3c\uc758 \ud2b9\uc131 \ubd84\uc11d\uc740 \uaddc\uc81c \uc2b9\uc778 \uc808\ucc28\uc758 \uc911\uc694\ud55c \ubd80\ubd84\uc785\ub2c8\ub2e4. ICH \uc9c0\uce68\uc5d0 \ub530\ub974\uba74, \ucd94\uc815 \uacb0\uacfc \ubd88\uc21c\ubb3c \ud568\ub7c9\uc774 0.1%\ub97c \ucd08\uacfc\ud558\ub294 \uacbd\uc6b0, \ubaa8\ub4e0 \uaddc\uc81c \uc694\uac74\uc744 \uc900\uc218\ud558\ub3c4\ub85d \ubd88\uc21c\ubb3c\uc744 \uc2dd\ubcc4\ud558\uace0 \ud2b9\uc131 \ubd84\uc11d\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \uacfc\uc815\uc740 <strong>\ubd88\uc21c\ubb3c \ud504\ub85c\ud30c\uc77c\ub9c1<\/strong> \uc774\ub77c\uace0\ub3c4 \ud569\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubcf8 \uae30\uc0ac\uc5d0\uc11c\ub294 \uc774 \uacfc\uc815\uc5d0 \ucd08\uc810\uc744 \ub9de\ucdb0 \ubd88\uc21c\ubb3c\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \ub9e5\ub77d\uc744 \uc81c\uacf5\ud558\uace0, Kymos Group\uc5d0\uc11c \ubd88\uc21c\ubb3c\uc744 \ucc98\ub9ac\ud560 \ub54c \uc0ac\uc6a9\ud558\ub294 \uae30\uc220\uacfc \uc7a5\ube44\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc124\uba85\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><strong>\ubd88\uc21c\ubb3c\uacfc \uadf8 \ubd84\ub958 \uc774\ud574<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">WHO \uc815\uc758\uc5d0 \ub530\ub974\uba74, \ubd88\uc21c\ubb3c\uc740 &#8220;\uc6d0\ud558\ub294 \uc81c\ud488, \uc81c\ud488 \uad00\ub828 \ubb3c\uc9c8, \ub610\ub294 \uc644\ucda9\uc561 \uc131\ubd84\uc744 \ud3ec\ud568\ud55c \ubd80\ud615\uc81c\uac00 \uc544\ub2cc, \uc6d0\ub8cc\uc758\uc57d\ud488 \ub610\ub294 \uc644\uc81c\uc758\uc57d\ud488\uc5d0 \uc874\uc7ac\ud558\ub294 \ubaa8\ub4e0 \uc131\ubd84&#8221;\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc774\ub294 \uacf5\uc815 \uad00\ub828 \ub610\ub294 \uc81c\ud488 \uad00\ub828\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \ubd88\uc21c\ubb3c\uc758 \ucd9c\ucc98\ub294 \uc57d\ubb3c \ubb3c\uc9c8 \ud569\uc131 \uacfc\uc815\uc758 \ub2e4\uc591\ud55c \ub2e8\uacc4\uc5d0\uc11c \uae30\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubd88\uc21c\ubb3c\uc740 \ucd9c\ubc1c \ubb3c\uc9c8, \uc81c\uc870 \uacf5\uc815, \ubcf4\uad00 \ubc0f \uc6b4\uc1a1 \uc911 \ubc1c\uc0dd\ud558\ub294 \ubd84\ud574 \uacfc\uc815\uc5d0\uc11c \uc0dd\uc131\ub420 \uc218 \uc788\uc73c\uba70, \uc2ec\uc9c0\uc5b4 \uc81c\uc870 \uacfc\uc815\uc5d0\uc11c \uc0ac\uc6a9\ub41c \uc6a9\ub9e4\uc5d0\uc11c\ub3c4 \ubc1c\uacac\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\">\uc57d\ubb3c \ubb3c\uc9c8\uc758 \ubd88\uc21c\ubb3c\uc5d0 \ub300\ud55c \ubd84\ub958<\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">ICH\ub294 \uc6d0\ub8cc, \uc131\ubd84, \uc0dd\ubb3c\ud559\uc801 \uc548\uc804\uc131\uc744 \uacb0\ud569\ud558\uc5ec \uc57d\ubb3c \ubb3c\uc9c8\uc758 \ubd88\uc21c\ubb3c\uc5d0 \ub300\ud55c \uc8fc\uc694 \ubd84\ub958\ub97c \ub0b4\ub193\uc558\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<ul>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>\uc720\uae30 \ubd88\uc21c\ubb3c:<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\uc81c\uc870 \uacfc\uc815\uc5d0\uc11c \ubc1c\uacac\ub418\uac70\ub098 \ubcf4\uad00 \uc911\uc5d0 \uc0dd\uc131\ub429\ub2c8\ub2e4. \uc2dd\ubcc4 \uac00\ub2a5\ud558\uac70\ub098 \uc2dd\ubcc4\ub418\uc9c0 \uc54a\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \ucd9c\ubc1c \ubb3c\uc9c8, \ubd80\uc0b0\ubb3c, \uc911\uac04\uccb4, \ubd84\ud574 \uc0b0\ubb3c, \uc2dc\uc57d, \ub9ac\uac04\ub4dc \ubc0f \ucd09\ub9e4\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.  <\/span><\/li>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>\ubb34\uae30 \ubd88\uc21c\ubb3c:  <\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\uc81c\uc870 \uacf5\uc815\uc5d0\uc11c \uc0dd\uc131\ub418\uba70 \uc77c\ubc18\uc801\uc73c\ub85c \uc54c\ub824\uc838 \uc788\uace0 \uc2dd\ubcc4\ub418\ub294 \ubb3c\uc9c8\uc785\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uc2dc\uc57d, \ub9ac\uac04\ub4dc, \ucd09\ub9e4, <a href=\"https:\/\/kymos.com\/ko\/%ec%84%9c%eb%b9%84%ec%8a%a4\/cmc-%eb%b6%84%ec%84%9d-%eb%b0%8f-%ed%92%88%ec%a7%88-%ea%b4%80%eb%a6%ac\/%ec%9b%90%ec%86%8c-%eb%8b%88%ed%8a%b8%eb%a1%9c%ec%82%ac%eb%af%bc-%eb%b0%8f-%ea%b8%b0%ed%83%80-%eb%b6%88%ec%88%9c%eb%ac%bc\/%ec%9b%90%ec%86%8c-%eb%b6%88%ec%88%9c%eb%ac%bc\/\" data-wpel-link=\"internal\">\uc911\uae08\uc18d \ub610\ub294 \uae30\ud0c0 \uc794\ub958 \uae08\uc18d<\/a> , \ubb34\uae30\uc5fc, \uadf8\ub9ac\uace0 \uc5ec\uacfc \ubcf4\uc870\uc81c\ub098 \uc22f\uacfc \uac19\uc740 \uae30\ud0c0 \ubb3c\uc9c8\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. <\/span><\/li>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>\uc794\ub958 \uc6a9\ub9e4:  <\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\uc81c\uc870 \uacf5\uc815\uc5d0\uc11c \uc720\ub798\ub418\uc5c8\uc73c\uba70, \uc778\uac04 \ub610\ub294 \ub3d9\ubb3c \uac74\uac15\uc5d0 \ub300\ud55c \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc744 \uae30\uc900\uc73c\ub85c \ubd84\ub958\ub429\ub2c8\ub2e4. <a href=\"https:\/\/kymos.com\/ko\/news\/vich-gl18-r2-%ec%88%98%ec%9d%98%ed%95%99-%ec%a0%9c%ed%92%88%ec%9d%98-%ec%9e%94%eb%a5%98-%ec%9a%a9%eb%a7%a4-%eb%b3%80%ea%b2%bd\/\" data-wpel-link=\"internal\">VICH GL18(R2) \ubc0f \uc794\ub958 \uc6a9\ub9e4\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uc138\uc694.<\/a> <\/span><\/li>\n<\/ul>\n<h2><strong>\ubd88\uc21c\ubb3c \uad00\ub9ac \ubc0f \ud2b9\uc131\ud654\uc5d0 \ub300\ud55c \uc9c0\uce68<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc55e\uc11c \uc5b8\uae09\ud588\ub4ef\uc774, ICH \uc9c0\uce68\uc5d0 \ub530\ub974\uba74 \uc2e0\uaddc \uc6d0\ub8cc\uc758\uc57d\ud488\uc5d0 0.1% \uc774\uc0c1\uc758 \ubbf8\uc9c0 \ubd88\uc21c\ubb3c\uc774 \uc874\uc7ac\ud558\ub294 \uacbd\uc6b0, \uadf8 \ubd88\uc21c\ubb3c\uc758 \ud2b9\uc131\uc744 \ubd84\uc11d\ud574\uc57c \ud569\ub2c8\ub2e4. \ubd88\uc21c\ubb3c\uc758 \ud568\ub7c9\uc774 \uc774 \uae30\uc900\uc744 \ucd08\uacfc\ud558\ub294 \uacbd\uc6b0, \ud574\ub2f9 \ubd88\uc21c\ubb3c\uc744 \uc2dd\ubcc4\ud558\uc5ec \uaddc\uaca9\uc5d0 \uac1c\ubcc4\uc801\uc73c\ub85c \uba85\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubc18\ub300\ub85c, \ubd88\uc21c\ubb3c\uc774 \uc774 \ud55c\ub3c4 \uc774\ud558\ub85c \ub5a8\uc5b4\uc9c0\uba74 \uc7a0\uc7ac\uc801\uc778 \ud53c\ud574\uac00 \ube44\uc815\uc0c1\uc801\uc73c\ub85c \ub192\uc744 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\ub294 \uc0c1\ud669\uc744 \uc81c\uc678\ud558\uace0\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc2dd\ubcc4\uc774 \ud544\uc694\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">ICH \uc9c0\uce68\uc5d0 \ub530\ub974\uba74, \uc758\uc57d\ud488 \uc548\uc815\uc131 \uc2dc\ud5d8\uc5d0\uc11c \uac80\ucd9c\ub41c \ubd84\ud574\uc0b0\ubb3c\uc774 \ud655\uc778 \uae30\uc900\uce58\ub97c \ucd08\uacfc\ud558\ub294 \uacbd\uc6b0, \ud574\ub2f9 \ubd84\ud574\uc0b0\ubb3c\ub3c4 \ud655\uc778\ud558\ub3c4\ub85d \uaddc\uc815\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uae30\uc900\uc740 <a href=\"https:\/\/www.ema.europa.eu\/en\/ich-q3a-r2-impurities-new-drug-substances-scientific-guideline\" data-wpel-link=\"external\">ICH Q3A(R2)\uc5d0 \uba85\uc2dc\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/a> <\/span><\/p>\n<h2><strong>\ubd88\uc21c\ubb3c \ud504\ub85c\ud30c\uc77c\ub9c1\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uae30\uc220<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\ubd88\uc21c\ubb3c\uacfc \ubd84\ud574\uc0b0\ubb3c\uc744 \uc2dd\ubcc4\ud560 \ub54c \ub2e4\uc591\ud55c \ubc29\ubc95\uc744 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uae30\uc874\uc758 \ubc29\ubc95\uc740 \uac1c\ubc1c\ub41c \ubc29\ubc95, \ud2b9\ud788 \uc2a4\ud30c\uc774\ud0b9(spiking)\uc744 \uc0ac\uc6a9\ud558\uc5ec \ubbf8\uc9c0 \ubd84\uc11d\ubb3c\uc758 \uba38\ubb34\ub984 \uc2dc\uac04\uc744 \ud45c\uc900\ubb3c\uc9c8\uacfc \ube44\uad50\ud558\ub294 \uac83\uc785\ub2c8\ub2e4.   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ud53c\ud06c\uac00 \uc2dd\ubcc4 \uc784\uacc4\uac12\uc744 \ucd08\uacfc\ud558\uba74 \uc2dd\ubcc4 \ubc0f \uad6c\uc870 \uaddc\uba85\uc744 \uc704\ud574 \ud45c\uc2dc\ub429\ub2c8\ub2e4. Kymos Group\uc5d0\uc11c\ub294 \uc774 \uacfc\uc815\uc774 \uc77c\ubc18\uc801\uc73c\ub85c <strong>UPLC \ub610\ub294 HPLC\ub97c \uc0ac\uc6a9\ud558\uc5ec \uc218\ud589\ub429\ub2c8\ub2e4.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \ubc29\ubc95\uc740 \uc218\ub144\uac04 \uc0ac\uc6a9\ub418\uc5b4 \uc654\uc9c0\ub9cc, <strong>\uc5ec\ub7ec \ubd88\uc21c\ubb3c\uc744 \ub2e8\uc77c \uc0d8\ud50c\uc5d0\uc11c \ud2b9\uc131\ud654\ud574\uc57c \ud560 \ub54c \ub354 \ube60\ub974\uace0 \uc27d\uac8c \uc0ac\uc6a9\ud560 \uc218 \uc788\uae30 \ub54c\ubb38\uc5d0 \uc6b0\ub9ac\ub294 \uc8fc\ub85c \ud558\uc774\ud508 \uae30\uc220\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\ubd88\uc548\uc815\ud55c \ubd88\uc21c\ubb3c\uc774 \ud615\uc131\ub418\uac70\ub098 \uac00\uacf5 \uc911\uc5d0 2\ucc28 \ubc18\uc751\uc774 \uc77c\uc5b4\ub0a0 \uac00\ub2a5\uc131\uc774 \uc788\ub294 \uacbd\uc6b0 \uc7a0\uc7ac\uc801\uc778 \ubb38\uc81c\ub97c \ud53c\ud560 \uc218 \uc788\uae30<\/strong> \ub54c\ubb38\uc5d0 \uc774\ub7ec\ud55c \ubc29\ubc95\uc774 \uc120\ud638\ub429\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uad6c\uccb4\uc801\uc778 \uc774\uc720 \ub54c\ubb38\uc5d0 \uc6b0\ub9ac\ub294 \uc54c\ub824\uc9c0\uc9c0 \uc54a\uc740 \ubd84\uc11d\ubb3c\uc5d0 \ub300\ud55c \uac70\uc758 \uba85\ud655\ud55c \uad6c\uc870\uc801 \uc815\ubcf4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub294 <strong>LC-MS<\/strong> \uc640 \ud2b9\ud788 Orbitrap \uc9c8\ub7c9 \ubd84\uc11d\uae30\ub97c \uc0ac\uc6a9\ud558\uae30\ub85c \uacb0\uc815\ud588\uc2b5\ub2c8\ub2e4.  <\/span><\/p>\n<h2><strong>Kymos \uadf8\ub8f9 \uc6a9\ub7c9 \ubc0f \uc0c8\ub85c\uc6b4 \uc2dc\uc124<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">2023\ub144 \ub0b4\ub0b4 \ub2f9\uc0ac \uc0ac\uc5c5\uc758 \uc9c0\uc18d\uc801\uc778 \uc131\uc7a5\uc5d0 \ub300\uc751\ud558\uace0, \ud2b9\ud788 \ubd88\uc21c\ubb3c \ubd84\uc11d \ubc0f \ud14c\uc2a4\ud2b8\uc640 \uad00\ub828\ud558\uc5ec \uace0\uac1d\uc758 \uc694\uad6c\ub97c \ucda9\uc871\ud558\uae30 \uc704\ud574 \ucd5c\uadfc \uc774\ud0c8\ub9ac\uc544\uc5d0 \uc788\ub294 \ub2f9\uc0ac \uc0ac\uc774\ud2b8\ub97c \uc0c8\ub85c\uc6b4 \uc2dc\uc124\ub85c \ud655\uc7a5\ud588\uc2b5\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uc0c8\ub85c\uc6b4 \uac74\ubb3c\uc740 \uae30\uc874 \uacf5\uc7a5\ubcf4\ub2e4 \uba74\uc801\uc774 3\ubc30\ub098 \ub113\uace0, <a href=\"https:\/\/kymos.com\/ko\/news\/u-shape-%eb%b0%8f-lean-lab-%ec%8b%a4%ed%97%98%ec%8b%a4-%ec%83%9d%ec%82%b0%ec%84%b1-%ed%96%a5%ec%83%81\/\" data-wpel-link=\"internal\">&#8220;\ub9b0 \ub7a9 \ubc29\uc2dd&#8221;\uc73c\ub85c \uc124\uacc4\ub41c 3\uac1c\uc758 \uc0c8\ub85c\uc6b4 \uc2e4\ud5d8\uc2e4\uc744 \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/a><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc804\ub7b5\uc801 \ud22c\uc790\ub294 \ubd88\uc21c\ubb3c \ubd84\uc11d \uc6a9\ub7c9\uc744 \ud06c\uac8c \uc99d\uac00\uc2dc\ud0ac \ubfd0\ub9cc \uc544\ub2c8\ub77c \uc0dd\ubb3c\uc57d\ud559 \uc81c\ud488\uc758 \uc5f0\uad6c, \uac1c\ubc1c \ubc0f \ud488\uc9c8 \uad00\ub9ac\uc5d0 \ub300\ud55c \uc11c\ube44\uc2a4 \ubc94\uc704\ub97c \ud655\ub300\ud560 \uac83\uc785\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uc0c8\ub85c\uc6b4 \uc2e4\ud5d8\uc2e4\uc740 \uc2dc\uc124\uc5d0 \ub300\ud55c \ucca0\uc800\ud55c \ubb3c\ub9ac\uc801 \uac10\uc0ac\ub97c \uac70\uccd0 AIFA(\uc774\ud0c8\ub9ac\uc544 \uc81c\uc57d\uccad)\uc758 \uc2b9\uc778\uc744 \uc774\ubbf8 \ubc1b\uc558\uc73c\uba70<\/strong> , \uc6b0\ub9ac\ub294 \uc55e\uc73c\ub85c \uc9c4\ud589\ub420 \ubaa8\ub4e0 \ud504\ub85c\uc81d\ud2b8\ub97c \uc9c0\uc6d0\ud560 \uc900\ube44\uac00 \ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\ubd88\uc21c\ubb3c \ud2b9\uc131\ud654 \ub610\ub294 CMC \ub610\ub294 \uc0dd\ubb3c \ubd84\uc11d \uc5f0\uad6c\uc5d0 \ub3c4\uc6c0\uc774 \ud544\uc694\ud558\uba74 <strong><a 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