{"id":26232,"date":"2025-05-08T08:09:53","date_gmt":"2025-05-07T23:09:53","guid":{"rendered":"https:\/\/www.sanctionlab.com\/?p=26232"},"modified":"2025-05-09T10:17:50","modified_gmt":"2025-05-09T01:17:50","slug":"%ec%9d%98%ec%95%bd%ed%92%88-%ec%9e%a5%eb%b2%bd-%eb%86%92%ec%9d%b8-%ed%8a%b8%eb%9f%bc%ed%94%84-%ec%85%80%ed%8a%b8%eb%a6%ac%ec%98%a8%c2%b7%ec%95%8c%ed%85%8c%ec%98%a4%ec%a0%a0-%eb%b3%b5%ec%9e%a1","status":"publish","type":"post","link":"https:\/\/www.sanctionlab.com\/?p=26232","title":{"rendered":"\uc758\uc57d\ud488 \uc7a5\ubcbd \ub192\uc778 \ud2b8\ub7fc\ud504, \uc140\ud2b8\ub9ac\uc628\u00b7\uc54c\ud14c\uc624\uc820 \ubcf5\uc7a1\ud55c \uc148\ubc95"},"content":{"rendered":"<h3>|\ud589\uc815\uba85\ub839\uc73c\ub85c \ud574\uc678 \uc81c\uc870\uc18c \uc2e4\uc0ac \uac15\ud654 \uc608\uace0, \uad6d\ub0b4 \ubc14\uc774\uc624 \uc5c5\uacc4 \uc2dc\uc124 \ud22c\uc790 \uacc4\ud68d \uc601\ud5a5<\/h3>\n<p>\ubbf8\uad6d\uc758 \uc758\uc57d\ud488 \uad00\uc138 \ubd80\uacfc \uac00\ub2a5\uc131\uc774 \ud604\uc2e4\ud654 \ub418\uba74\uc11c \uad6d\ub0b4 \uc758\uc57d\ud488 \uc0dd\uc0b0 \uae30\uc5c5\ub4e4\uc758 \uc148\ubc95\ub3c4 \ubcf5\uc7a1\ud574\uc84c\ub2e4. \ub3c4\ub110\ub4dc \ud2b8\ub7fc\ud504 \ubbf8\uad6d \ub300\ud1b5\ub839\uc774 \uc758\uc57d\ud488 \uad00\uc138 \ubd80\uacfc\ub97c \uc0ac\uc2e4\uc0c1 \ud655\uc815\uc9c0\uc740\ub370\ub2e4 \ud574\uc678 \uc81c\uc870 \uc758\uc57d\ud488 \uc218\uc785\uc744 \ub9c9\uae30 \uc704\ud55c \ud589\uc815\uba85\ub839\uc5d0\ub3c4 \uc11c\uba85\ud588\ub2e4. \uc758\uc57d\ud488 \uc9c4\uc785\uc7a5\ubcbd\uc774 \ud55c\uce35 \ub354 \ub192\uc544\uc9c4 \uc0c1\ud669\uc774\ub2e4.<\/p>\n<p>\ud574\uc678 \uc0dd\uc0b0 \uc758\uc57d\ud488\uc5d0 \ub300\ud55c \uad00\uc138 \ubd80\uacfc\uc640 \uc774\ubc88 \ud589\uc815\uba85\ub839\uc740 \ud2b8\ub7fc\ud504 \ud589\uc815\ubd80\uac00 \uc6d0\ud558\ub294 \ub0b4\uc218 \uc911\uc2ec \uc758\uc57d\ud488 \uacf5\uae09\ub9dd \uad6c\ucd95\uc5d0 \ubd88\uc744 \ubd99\uc600\ub2e4. \uae00\ub85c\ubc8c 1\uc704 \uc758\uc57d\ud488 \uc2dc\uc7a5\uc778 \ubbf8\uad6d\uc5d0 \ub300\ud55c \uacf5\uae09\ub9dd \uad6c\uc870 \uae09\ubcc0\uc740 \uad6d\ub0b4 \uc81c\uc57d\ubc14\uc774\uc624 \uae30\uc5c5\uc758 \uc2dc\uc124 \ud655\ucda9 \uacc4\ud68d\uc5d0\ub3c4 \uc601\ud5a5\uc744 \ubbf8\ucce4\ub2e4.<\/p>\n<p><strong>\u25c7\ud2b8\ub7fc\ud504, \uad00\uc138\u00b7\ud589\uc815\uba85\ub839\uc73c\ub85c &#8216;\ub0b4\uc218 \uc911\uc2ec&#8217; \uc758\uc57d\ud488 \uacf5\uae09\ub9dd \uad6c\ucd95<\/strong><\/p>\n<p>\ud2b8\ub7fc\ud504 \ub300\ud1b5\ub839\uc740 \ud604\uc9c0\uc2dc\uac04 5\uc77c \ubbf8\uad6d \ub0b4 \ucc98\ubc29\uc57d \uc81c\uc870\uc5d0 \ub300\ud55c \uc778\uc13c\ud2f0\ube0c\ub97c \uc81c\uacf5\ud558\ub294 \ud589\uc815\uba85\ub839\uc5d0 \uc11c\uba85\ud588\ub2e4. 2\uc8fc \uc774\ub0b4\ub85c \uc218\uc785 \uc758\uc57d\ud488\uc5d0 \ub300\ud55c \uad00\uc138 \uc815\ucc45\uc744 \ubc1c\ud45c\ud558\uaca0\ub2e4\uace0 \uacf5\uc5b8\ud55c \uac00\uc6b4\ub370 \ud2b8\ub7fc\ud504\ud45c \uc758\uc57d\ud488 \uc815\ucc45\uc758 \ud575\uc2ec\uc778 &#8216;\uad6d\ub0b4 \uc0dd\uc0b0&#8217;\uc744 \ucd09\uc9c4\ud560 \uc218 \uc788\ub294 \uc870\uce58\ub97c \ucde8\ud55c \uc148\uc774\ub2e4.<\/p>\n<p>\uc774\ubc88 \ud589\uc815\uba85\ub839\uc740 \ubbf8\uad6d \ub0b4 \uc758\uc57d\ud488 \uc0dd\uc0b0 \uc2dc\uc124 \ud655\ub300 \uac00\uc18d\ud654\ub97c \uc704\ud55c \ud5c8\uac00 \uc808\ucc28 \ub2e8\ucd95\uc774 \uace8\uc790\ub2e4. \ud558\uc9c0\ub9cc \uc8fc\ubaa9\ud560\ub9cc\ud55c \ub300\ubaa9\uc740 \ub530\ub85c \uc788\ub2e4. \ubc14\ub85c \ud574\uc678 \uc81c\uc870 \uacf5\uc7a5\uc5d0 \ub300\ud55c &#8216;\uc81c\uc7ac&#8217;\ub2e4.<\/p>\n<div><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-26233\" src=\"https:\/\/www.sanctionlab.com\/wp-content\/uploads\/2025\/05\/20250508080246298_n.jpg\" alt=\"\" width=\"640\" height=\"272\" srcset=\"https:\/\/www.sanctionlab.com\/wp-content\/uploads\/2025\/05\/20250508080246298_n.jpg 640w, https:\/\/www.sanctionlab.com\/wp-content\/uploads\/2025\/05\/20250508080246298_n-300x128.jpg 300w, https:\/\/www.sanctionlab.com\/wp-content\/uploads\/2025\/05\/20250508080246298_n-150x64.jpg 150w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/div>\n<p>\ubc31\uc545\uad00\uc740 \uc774\ubc88 \ud589\uc815\uba85\ub839\uc744 \ud1b5\ud574 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uac00 \ud574\uc678 \uc81c\uc870 \uacf5\uc7a5\uc5d0 \ub300\ud55c \uc2e4\uc0ac \uae30\uc900\uc744 \uac15\ud654\ud560 \uac83\uc744 \uba85\ub839\ud588\ub2e4. \ud2b9\ud788 \ud574\uc678 \uc81c\uc57d\uae30\uc5c5\uc758 \ud65c\uc131 \uc81c\uc57d \uc131\ubd84 \uc6d0\ub8cc \ubcf4\uace0 \uc900\uc218 \uc5ec\ubd80\ub97c \uac80\ud1a0\ud558\uace0 \uc900\uc218\ud558\uc9c0 \uc54a\ub294 \uc2dc\uc124 \ubaa9\ub85d\uc5d0 \ub300\ud55c \uacf5\uac1c \uac80\ud1a0\uc5d0 \ub300\ud55c \ub0b4\uc6a9\ub3c4 \ub2f4\uacbc\ub2e4.<\/p>\n<p>\ud604\ud589 FDA\ub294 \uc0b0\ud558 \uac80\uc0ac \ubc0f \uc870\uc0ac\uad6d(OII)\uc744 \ud1b5\ud574 \uc758\uc57d\ud488 \uc81c\uc870 \uacf5\uc7a5\uc5d0 \ub300\ud55c \uccab cGMP \ud5c8\uac00 \uc2e4\uc0ac \uc774\ud6c4 2~3\ub144 \uc8fc\uae30\ub85c \uc2e4\uc0ac\ub97c \uc9c4\ud589\ud55c\ub2e4. \ub2e4\ub9cc \ubbf8\uad6d \ub0b4 \uacf5\uc7a5\uc740 \uc0ac\uc804 \ud1b5\uc9c0 \uc5c6\uc774 \uc2e4\uc0ac\uac00 \uc9c4\ud589\ub418\uc9c0\ub9cc \ud574\uc678\ub294 \ubc29\ubb38 \uc77c\uc815 \uc870\uc815 \ub4f1\uc744 \uc774\uc720\ub85c \uc0ac\uc804 \ud1b5\uc9c0 \ud6c4 \uc9c4\ud589\ub410\ub2e4. \uac8c\ub2e4\uac00 \ud604\uc7a5 \uc2e4\uc0ac\uc5d0 \ub300\ud55c \ubd80\ub2f4 \ub4f1 \ud604\uc2e4\uc801\uc778 \uc774\uc720\ub85c \uc2e4\uc0ac\uac00 \uc885\uc885 \uba74\uc81c\ub418\uae30\ub3c4 \ud588\ub2e4.<\/p>\n<p>FDA\ub294 \ud589\uc815\uba85\ub839 \ubc1c\ud6a8 \uc774\ud6c4 90\uc77c \uc774\ub0b4 \ud574\uc678 \uc81c\uc870 \uc2dc\uc124\uc5d0 \ub300\ud55c \uc2e4\uc0ac \uac1c\uc120 \ubc29\uc548 \ub9c8\ub828\uc744 \ucd94\uc9c4\ud574\uc57c \ud55c\ub2e4. FDA\ub294 \ud589\uc815\uba85\ub839 \uc11c\uba85 \uc774\ud2bf\ub0a0\uc778 6\uc77c \ud574\uc678 \uc81c\uc870 \uc2dc\uc124\uc5d0 \ub300\ud55c \ubd88\uc2dc \uac80\ubb38 \ud655\ub300 \uacc4\ud68d\uc744 \ubc1c\ud45c\ud558\uba70 \uc2e4\uc0ac \uac15\ud654\uc758 \uc2e0\ud638\ud0c4\uc744 \ud130\ub728\ub838\ub2e4.<\/p>\n<p>\ub9cc\uc57d \uc2e4\uc0ac\uac00 \uac15\ud654\ub41c\ub2e4\uba74 \uad6d\ub0b4 CDMO \uc5c5\uccb4\ub294 \ubb3c\ub860 \uc644\uc81c\ud488\uc744 \uc9c1\uc811 \uc0dd\uc0b0\ud574 \ubbf8\uad6d\uc5d0 \uc218\ucd9c\ud558\ub294 \uad6d\ub0b4 \uc81c\uc57d\ubc14\uc774\uc624 \uae30\uc5c5\uc740 \ud488\uc9c8\uad00\ub9ac\uc640 \uaddc\uc81c \ub300\uc751\uc5d0 \ub300\ud55c \ubd80\ub2f4\uc774 \uac00\uc911\ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub41c\ub2e4.<\/p>\n<p>\uc218\uc218\ub8cc \uc778\uc0c1 \uc5ec\ubd80\ub3c4 \ubcf5\ubcd1\uc774\ub2e4. \ud2b8\ub7fc\ud504 \uc815\ubd80\ub294 \uc2e4\uc0ac \uae30\uc900 \uac15\ud654\uc5d0 \ub530\ub77c \ucd94\uac00\uc801\uc73c\ub85c \ubc1c\uc0dd\ud558\ub294 \ube44\uc6a9\uc5d0 \ub300\ud55c \uc7ac\uc6d0\uc740 \uc2e4\uc0ac \uc218\uc218\ub8cc \uc778\uc0c1\uc744 \ud1b5\ud574 \ub9c8\ub828\ud558\uaca0\ub2e4\uace0 \ubc1d\ud614\ub2e4. FDA\ub294 \ud604\uc7ac \uc815\uae30 \uc2e4\uc0ac\uc5d0 \ub300\ud55c \uc218\uc218\ub8cc\ub294 \ub530\ub85c \ubc1b\uc9c0 \uc54a\uace0 \uc758\uc57d\ud488 \ud5c8\uac00 \uc2ec\uc0ac \ub610\ub294 \ud574\uc678 \uc81c\uc870\uc18c \ucd94\uac00 \uc2b9\uc778 \ub2f9\uc2dc\uc5d0\ub9cc \uc2ec\uc0ac \uc218\uc218\ub8cc\uc5d0 \uc2e4\uc0ac \uad00\ub828 \uc218\uc218\ub8cc\ub97c \ud3ec\ud568\uc2dc\ud0a4\uace0 \uc788\ub2e4.<\/p>\n<p>FDA \ucd9c\uc2e0 \ubc14\uc774\uc624 \uc5c5\uacc4 \uad00\uacc4\uc790\ub294 &#8220;FDA\ub294 \uc774\ubbf8 \uba87\ub144\uac04 \uc790\uae08\ub09c \ub4f1\uc744 \uc774\uc720\ub85c \uc218\uc218\ub8cc\ub97c \uacc4\uc18d\ud574\uc11c \uc778\uc0c1\ud558\uace0 \uc788\ub2e4&#8221;\uba70 &#8220;\ub9cc\uc57d \uc774\ubc88 \ud589\uc815\uba85\ub839\uc73c\ub85c \uc2e4\uc0ac\uc5d0 \ub300\ud55c \uc218\uc218\ub8cc\uac00 \ucee4\uc9c4\ub2e4\uba74 \uae30\uc5c5\ub4e4\uc758 \ube44\uc6a9 \ubd80\ub2f4\uc740 \ub354\uc6b1 \ucee4\uc9c8 \uac83&#8221;\uc774\ub77c\uace0 \ub9d0\ud588\ub2e4.<\/p>\n<p><strong>\u25c7\uacf5\uae09\ub9dd \uad6c\uc870 \ubcc0\ud654\uc5d0 \uc148\ubc95 \ubcf5\uc7a1\ud574\uc9c4 \uc5c5\uacc4\u2026\uc2dc\uc124 \ud22c\uc790 \uacc4\ud68d \ucc28\uc9c8 \ube5a\uae30\ub3c4<\/strong><\/p>\n<p>\ud2b8\ub7fc\ud504 \uc815\ubd80\uac00 \uad00\uc138\uc5d0 \uc774\uc5b4 \ud589\uc815\uba85\ub839\uc73c\ub85c \uc758\uc57d\ud488 \uacf5\uae09\ub9dd \ub0b4\uc7ac\ud654\uc5d0 \uc18d\ub3c4\ub97c \ub0b4\uba74\uc11c \uc81c\uc57d\ubc14\uc774\uc624 \uc5c5\uacc4\uc758 \uc148\ubc95\ub3c4 \ubcf5\uc7a1\ud574\uc84c\ub2e4. \uc9c0\ub09c\ud574\ub9cc \ud574\ub3c4 \ubbf8\uad6d \uc815\ubd80\uc758 \uacf5\uae09\ub9dd \ub2e4\ubcc0\ud654 \uc815\ucc45\uc744 \uae30\ubc18\uc73c\ub85c \uc0dd\uc0b0 \uc2dc\uc124 \ud655\ub300\uc5d0 \ub300\ud55c \ub17c\uc758\uac00 \ud65c\ubc1c\ud588\uc9c0\ub9cc \uae09\ubcc0\ud558\ub294 \uc815\ucc45 \uae30\uc870\ub85c \ubd88\ud655\uc2e4\uc131\uc774 \ucee4\uc84c\uae30 \ub54c\ubb38\uc774\ub2e4.<\/p>\n<p>\ube45\ud30c\ub9c8\ub4e4\uc740 \ud574\uc678 \uc81c\uc870 \uc2dc\uc124 \ud655\ub300 \uacc4\ud68d\uc744 \uba48\ucd94\uace0 \ub9ac\uc1fc\uc5b4\ub9c1\uc744 \ud0dd\ud588\ub2e4. \uc77c\ub77c\uc774\ub9b4\ub9ac, MSD\ub97c \uc2dc\uc791\uc73c\ub85c 10\uc5ec\uacf3\uc5d0 \uc774\ub974\ub294 \ube45\ud30c\ub9c8\ub4e4\uc774 \ubbf8\uad6d \ub0b4 \uc0dd\uc0b0\uc2dc\uc124 \ud655\ub300 \uacc4\ud68d\uc744 \ubc1c\ud45c\ud588\ub2e4.<\/p>\n<p>\uad6d\ub0b4 \uc81c\uc57d\ubc14\uc774\uc624 \uc5c5\uacc4\ub3c4 \ub9c8\ucc2c\uac00\uc9c0\ub2e4. \uc774\ubc88 \ud589\uc815\uba85\ub839\uc73c\ub85c \ubbf8\uad6d \ub0b4 \uc81c\uc870 \uacf5\uc7a5 \uc124\ub9bd \uc808\ucc28\uac00 \uac04\uc18c\ud654\ub418\uba74\uc11c \ud604\uc9c0 \uc0dd\uc0b0 \uc2dc\uc124 \ud655\ucda9\uc744 \uace0\ubbfc\ud558\ub294 \uae30\uc5c5\ub4e4\uc774 \ud558\ub098 \ub458 \uc0dd\uae30\uace0 \uc788\ub2e4. \uc140\ud2b8\ub9ac\uc628\uc758 \uacbd\uc6b0 \ubbf8\uad6d \uc6d0\ub8cc\uc758\uc57d\ud488 \uc0dd\uc0b0\uc2dc\uc124 \ud655\ubcf4\uc5d0 \ub300\ud55c \uc608\ube44 \uac80\ud1a0\ub97c \ub05d\ub0c8\ub2e4\uace0 \ubc1d\ud614\ub2e4.<\/p>\n<p>\ubc18\uba74 \uad6d\ub0b4 \uc0dd\uc0b0 \uc2dc\uc124 \ud655\ucda9 \uacc4\ud68d\uc744 \uc138\uc6e0\ub358 \uc77c\ubd80 \uae30\uc5c5\uc740 \uacc4\ud68d\uc5d0 \ucc28\uc9c8\uc774 \ube5a\uc5b4\uc9c0\uae30\ub3c4 \ud588\ub2e4.<\/p>\n<p>\uc54c\ud14c\uc624\uc820\uc740 \uc624\ub9ac\uc628\uacfc \ud569\uc791\ubc95\uc778(JV) \uc124\ub9bd\uc744 \ud1b5\ud574 \uc790\uccb4 \uacf5\uc7a5 \uc124\ub9bd\uc744 \ucd94\uc9c4 \uc911\uc774\uc5c8\ub2e4. \uc8fc\uc694 \uc81c\ud488\uc758 \uc0c1\uc6a9\ud654\ub97c \uc55e\ub450\uace0 \ubb3c\ub7c9 \ub300\uc751\uc744 \uc704\ud55c \uc124\ube44 \ud655\ucda9\uc774 \ud544\uc694\ud574\uc9c0\uba74\uc11c\ub2e4. \uc774\ubbf8 \uc0dd\uc0b0 \ubd80\uc9c0\uc5d0 \ub300\ud55c \ud569\uc758\ub3c4 \ub9c8\ubb34\ub9ac \ub2e8\uacc4\uc5d0 \uc811\uc5b4\ub4e4\uc5c8\uc9c0\ub9cc \ucd5c\uadfc \ud2b8\ub7fc\ud504 \uc815\ubd80\uc758 \uc815\ucc45 \ubcc0\ud654\ub85c \uc778\ud574 \ub9c8\uce68\ud45c\ub97c \ucc0d\uc9c0 \ubabb\ud558\uace0 \uc788\ub294 \uc0c1\ud669\uc774\ub2e4.<\/p>\n<p>\ubc14\uc774\uc624 \uc5c5\uacc4 \uad00\uacc4\uc790\ub294 &#8220;\ubbf8\uad6d \uc218\ucd9c\uc744 \uc5fc\ub450\uc5d0 \ub450\uace0 \uc788\ub294 \uae30\uc5c5\ub4e4 \uc785\uc7a5\uc5d0\uc11c\ub294 \ud604\uc7ac \uad6d\ub0b4\uc5d0 \uc0dd\uc0b0 \uc2dc\uc124\uc744 \ud655\ucda9\ud558\ub294 \uac83\uc774 \uc218\uc9c0\ud0c0\uc0b0\uc5d0 \ub9de\ub294\uc9c0 \uac70\ub4ed \uace0\ubbfc\ud558\uace0 \uc788\ub294 \uc0c1\ud669&#8221;\uc774\ub77c\uba70 &#8220;\uad00\uc138\ub294 \ubb3c\ub860 \ud574\uc678 \uc0dd\uc0b0 \uc2b9\uc778\uc5d0 \ub300\ud55c \uc9c4\uc785\uc7a5\ubcbd\ub3c4 \ub192\uc544\uc9c0\uba74\uc11c \uae30\uc874 \uacc4\ud68d\uc744 \uacc4\uc18d \ucd94\uc9c4\ud558\uae30\uc5d4 \ubd80\ub2f4\uc774 \ud074 \uac83&#8221;\uc774\ub77c\uace0 \ub9d0\ud588\ub2e4.<\/p>\n<p>\/ \uae40\uc131\uc544 \ub354\ubca8 \uae30\uc790<\/p>\n","protected":false},"excerpt":{"rendered":"<p>|\ud589\uc815\uba85\ub839\uc73c\ub85c \ud574\uc678 \uc81c\uc870\uc18c \uc2e4\uc0ac \uac15\ud654 \uc608\uace0, 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