{"id":41849,"date":"2026-06-23T12:50:40","date_gmt":"2026-06-23T10:50:40","guid":{"rendered":"https:\/\/kymos.com\/news\/%ec%9d%b4%ec%a4%91%ed%8a%b9%ec%9d%b4%ec%84%b1-%ed%95%ad%ec%b2%b4-%ec%95%bd%eb%8f%99%ed%95%99-%eb%b0%8f-%eb%a9%b4%ec%97%ad%ec%9b%90%ec%84%b1-%ec%97%b0%ea%b5%ac%ec%9d%98-%ea%b3%bc%ec%a0%9c\/"},"modified":"2026-06-23T12:50:40","modified_gmt":"2026-06-23T10:50:40","slug":"%ec%9d%b4%ec%a4%91%ed%8a%b9%ec%9d%b4%ec%84%b1-%ed%95%ad%ec%b2%b4-%ec%95%bd%eb%8f%99%ed%95%99-%eb%b0%8f-%eb%a9%b4%ec%97%ad%ec%9b%90%ec%84%b1-%ec%97%b0%ea%b5%ac%ec%9d%98-%ea%b3%bc%ec%a0%9c","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%ec%9d%b4%ec%a4%91%ed%8a%b9%ec%9d%b4%ec%84%b1-%ed%95%ad%ec%b2%b4-%ec%95%bd%eb%8f%99%ed%95%99-%eb%b0%8f-%eb%a9%b4%ec%97%ad%ec%9b%90%ec%84%b1-%ec%97%b0%ea%b5%ac%ec%9d%98-%ea%b3%bc%ec%a0%9c\/","title":{"rendered":"\uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4: \uc57d\ub3d9\ud559 \ubc0f \uba74\uc5ed\uc6d0\uc131 \uc5f0\uad6c\uc758 \uacfc\uc81c"},"content":{"rendered":"

\uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h2>\n

\uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4(BsAbs<\/strong>)\ub294 \ub450 \ud45c\uc801(\ud56d\uc6d0 \ub610\ub294 \uc5d0\ud53c\ud1a0\ud504)\uc5d0 \ub3d9\uc2dc\uc5d0 \uacb0\ud569\ud560 \uc218 \uc788\ub294 \uace0\uc720\ud55c \ub2a5\ub825<\/strong>\uc744 \uac16\ub3c4\ub85d \uc124\uacc4\ub41c \ud56d\uccb4\ub85c, \ub6f0\uc5b4\ub09c \ud6a8\ub2a5, \ud2b9\uc774\uc131 \ubc0f \uc548\uc804\uc131 \ud504\ub85c\ud30c\uc77c\uc744 \ubcf4\uc785\ub2c8\ub2e4. \uac1c\ubc1c \uc911\uc778 BsAbs\uc758 \uc801\uc6a9 \ubc94\uc704\ub294 \uc138\ud3ec \uac04 \ube0c\ub9ac\uc9d5, \uadfc\uc811 \ud6a8\uacfc, \uc774\uc911 \ud45c\uc801 \uc5b5\uc81c, \uadf8\ub9ac\uace0 \ub450 \uac00\uc9c0 \ud56d\uc6d0 \uc720\ud615\uc5d0 \uc758\uc874\ud558\ub294 \uc138\ud3ec \ud45c\uc801\ud654<\/strong>\ub97c \ud3ec\uad04\ud569\ub2c8\ub2e4. \uc774\ub4e4\uc740 \uc554 \uce58\ub8cc\uc5d0\uc11c \ud070 \uad00\uc2ec\uc744 \ubc1b\uc544\uc654\uc73c\uba70, \uadf8\ub7fc\uc5d0\ub3c4 \ucd5c\uadfc \uba87 \ub144 \uc0ac\uc774 \ub2e4\ub978 \uce58\ub8cc \uc601\uc5ed\uc5d0\uc11c\ub3c4 \ub354 \ub9ce\uc740 BsAbs\uac00 \ucd9c\uc2dc\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n

\ud56d\uccb4\ub294 \uc138\ud3ec \uc218\uc6a9\uccb4 \ubc0f \ubcf4\uccb4\uc640 \uc0c1\ud638\uc791\uc6a9\ud558\ub294 \uc77c\uc815 \uc601\uc5ed\uc778 Fc(Fragment crystallizable) \ub3c4\uba54\uc778<\/strong>\uacfc, \uac00\ubcc0 \uc911\uc1c4(Variable Heavy chain) \ubc0f \uac00\ubcc0 \uacbd\uc1c4(Variable Light chain)\ub97c \ud3ec\ud568\ud558\uba70 \ud45c\uc801\uc744 \uc778\uc9c0\ud558\ub294 Fab(Fragment antigen-binding) \ub3c4\uba54\uc778<\/strong>\uc73c\ub85c \uad6c\uc131\ub429\ub2c8\ub2e4.<\/span><\/p>\n

BsAbs\ub294 Fab \uc601\uc5ed\uc5d0 \uc11c\ub85c \ub2e4\ub978 \ub450 \uac1c\uc758 \ud314(arm)\uc744 \uac16\ub3c4\ub85d \uc124\uacc4<\/strong>\ub418\uba70, \uac01\uac01 \uace0\uc720\ud55c \uac00\ubcc0 \uacbd\uc1c4 \ubc0f \uc911\uc1c4\ub97c \uac00\uc9c0\uace0 \ud2b9\uc815 \ud45c\uc801\uc744 \uc778\uc9c0\ud560 \uc218 \uc788\uc5b4 \ub450 \ud56d\uc6d0\uc5d0 \ub3d9\uc2dc\uc5d0 \uacb0\ud569<\/strong>\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. BsAbs\ub97c \uc124\uacc4\ud560 \ub54c \uc8fc\uc694 \uace0\ub824\uc0ac\ud56d\uc740 Fab \uc601\uc5ed\uc758 \uc11c\ub85c \ub2e4\ub978 \ub450 \uc911\uc1c4\uc640 \uacbd\uc1c4\uac00 \uc62c\ubc14\ub974\uac8c \uc870\ub9bd\ub418\ub3c4\ub85d \ubcf4\uc7a5\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \ub610\ud55c Fc\uc5d0 \ub300\ud55c BsAbs\uc758 \ubcc0\ud615\uc740 \uc548\uc815\uc131\uc744 \ucd09\uc9c4 \ubc0f \ud5a5\uc0c1\uc2dc\ud0a4\uace0, \uba74\uc5ed \uae30\ub2a5\uc744 \uc870\uc808\ud558\uba70, \ubc18\uac10\uae30\ub97c \uc99d\uac00\uc2dc\ud0b5\ub2c8\ub2e4. <\/span><\/p>\n

BsAbs \uac1c\ubc1c\uc5d0\uc11c\ub294 \ucd5c\uc801\uc758 \ud6c4\ubcf4\ub97c \uc120\uc815\ud558\ub294 \uac83\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/strong> \uc774\ub7ec\ud55c \uc120\uc815\uc740 \ubb3c\ub9ac\ud654\ud559\uc801 \ud2b9\uc131, \ud3ec\ub9f7, \ud2b9\uc774\uc131, \uc57d\ub3d9\ud559(PK) \ubc0f \uc758\ub3c4\ud55c \uce58\ub8cc \ud6a8\uacfc\ub97c \uae30\ubc18\uc73c\ub85c \ud569\ub2c8\ub2e4.<\/span><\/p>\n

BsAbs \uac1c\ubc1c\uc5d0\uc11c \uc77c\ubc18\uc801\uc73c\ub85c \uace0\ub824\ub418\ub294 \ud30c\ub77c\ubbf8\ud130\ub294 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h2>\n

\uc548\uc804\uc131, \ud488\uc9c8 \ubc0f \uc720\ud6a8\uc131\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ubd84\uc11d \ud504\ub85c\uadf8\ub7a8\uc740 \ub124 \uac00\uc9c0 \uc8fc\uc694 \ubc94\uc8fc\uc5d0 \uac78\uce5c \uc5ec\ub7ec \ud575\uc2ec \ud488\uc9c8 \ud2b9\uc131(CQA)\uc744 \ud3c9\uac00\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/p>\n

    \n
  • \n

    \uc548\uc804\uc131:<\/b> \uc5d4\ub3c4\ud1a1\uc2e0, \ub9c8\uc774\ucf54\ud50c\ub77c\uc2a4\ub9c8, \uba74\uc5ed\uc6d0\uc131(ADA, NAb), \ubcd1\uc6d0\uccb4 \uc874\uc7ac \uc5ec\ubd80.<\/span><\/p>\n<\/li>\n

  • \n

    \ud488\uc9c8:<\/b> \ub2f9\ud654, \uc751\uc9d1, \uc219\uc8fc\uc138\ud3ec \ub2e8\ubc31\uc9c8(HCP), \uc219\uc8fc\uc138\ud3ec DNA(HCDNA).<\/span><\/p>\n<\/li>\n

  • \n

    \ub3d9\uc77c\uc131 \ubc0f \uc21c\ub3c4:<\/b> \ud06c\uae30, \uc544\ubbf8\ub178\uc0b0 \uc11c\uc5f4, \uae00\ub9ac\uce78 \ubd84\uc11d(ELISA, LC-MS, SEC-HPLC, SDS-PAGE).<\/span><\/p>\n<\/li>\n

  • \n

    \uc5ed\uac00:<\/b> \ud45c\uc801 \uacb0\ud569(ELISA, SPR), \uc138\ud3ec \ubc18\uc751 \ubc0f \uc138\ud3ec\ub3c5\uc131(\uc138\ud3ec \uae30\ubc18 \ubd84\uc11d, ADCC).<\/span><\/p>\n<\/li>\n<\/ul>\n

    BsAbs \uac1c\ubc1c\uc5d0\uc11c\uc758 \uc804\uc784\uc0c1 \ubc0f \uc784\uc0c1 \uace0\ub824\uc0ac\ud56d<\/h2>\n

    \uc57d\ub3d9\ud559(PK)<\/h3>\n

     <\/p>\n

    BsAbs\ub294 \uace0\uc720\ud55c \uc57d\ub3d9\ud559\uc801 \uacfc\uc81c<\/strong>\ub97c \uc81c\uc2dc\ud558\uba70, \uc774\ub294 PK \ud504\ub85c\ud30c\uc77c, \uc6a9\ub7c9 \uc124\uacc4, \ubc18\uac10\uae30 \ubc0f \uccad\uc18c\uc728 \ud3c9\uac00\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4. BsAbs\ub294 \uc704\uc7a5\uad00\uc5d0\uc11c \uc548\uc815\uc131\uc774 \ub0ae\uace0 \uc7a5\ubcbd \ud22c\uacfc\uc131\uc774 \uac10\uc18c\ud558\ubbc0\ub85c \uacbd\uad6c \ud6c4\ubcf4\ub85c \uc801\ud569\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ub300\uc2e0 BsAbs\ub294 \uc815\ub9e5(IV), \ubcf5\uac15(IP) \ub610\ub294 \ud53c\ud558(SC) \uc8fc\uc0ac\ub85c \ud22c\uc5ec\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/strong> <\/span><\/p>\n

    \ubd84\uc790 \ud06c\uae30\uc640 \uae30\ud0c0 \ubb3c\ub9ac\ud654\ud559\uc801 \ud2b9\uc131\uc740 \ubd84\ud3ec \ubc0f \uc870\uc9c1 \uce68\ud22c\uc5d0 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4.<\/strong> BsAbs\uc758 Fc \uc601\uc5ed\uc740 \uc804\uc2e0 \ub0b4 \uc874\uc7ac\ub97c \uc720\uc9c0\ud558\uace0 \uac15\ud654\ud558\ub294 \uc5ed\ud560\uc744 \ud558\uc5ec, \ube48\ubc88\ud55c \ud22c\uc5ec \ud544\uc694\uc131\uc744 \uc904\uc785\ub2c8\ub2e4.<\/span><\/p>\n

    PK \ud504\ub85c\ud30c\uc77c\uacfc \uc120\ud615\uc131\uc774 \uae30\uc874 \ub2e8\ud074\ub860 \ud56d\uccb4(mAbs)\uc640 \ub2e4\ub97c \uc218 \uc788\uc73c\ubbc0\ub85c, PK \ubc14\uc774\uc624\ubd84\uc11d \uc5f0\uad6c\uc5d0\uc11c\ub294 \ucd1d \ud56d\uccb4, \uac1c\ubcc4 \ud65c\uc131 \ud314, \ub610\ub294 \uacb0\ud569 \ubcf5\ud569\uccb4 \ub4f1 \uc5b4\ub5a4 \ubd84\uc11d\ubb3c(analyte)\uc744 \uce21\uc815\ud574\uc57c \ud558\ub294\uc9c0 \uc815\ud655\ud788 \uaddc\uc815\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/strong><\/span><\/p>\n

    \uc57d\ub825\ud559(PD)<\/h3>\n

     <\/p>\n

    \uc548\uc804\uc131 \ud3c9\uac00\uc758 \uc77c\ud658\uc73c\ub85c \ud2b9\uc815 \ubc14\uc774\uc624\ub9c8\ucee4\uc640 \uc0ac\uc774\ud1a0\uce74\uc778\uc744 \uce21\uc815\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/strong> \uc774\ub294 \uc6a9\ub7c9 \uc99d\ub7c9 \ub2e8\uacc4\uc5d0\uc11c \ub9e4\uc6b0 \uc911\uc694\ud55c \ub2e8\uacc4\uc774\uba70, \uc6a9\ub7c9 \uc99d\uac00\uac00 \uc0ac\uc774\ud1a0\uce74\uc778 \ubc29\ucd9c \uc99d\ud6c4\uad70(CRS)\uc744 \uc720\ubc1c\ud560 \uc218 \uc788\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/span><\/p>\n

    \uba74\uc5ed\uc6d0\uc131 \uc704\ud5d8<\/h3>\n

     <\/p>\n

    \ud56d\uc57d\ubb3c \ud56d\uccb4(ADA) \ud3c9\uac00\ub294 \uae30\uc874 mAbs\uc5d0 \ub300\ud55c \ud45c\uc900 ADA \ubd84\uc11d\ubc95\uacfc \ube44\uad50\ud560 \ub54c \ud6e8\uc52c \ub354 \uc5b4\ub835\uc2b5\ub2c8\ub2e4.<\/strong> \uc804\ud1b5\uc801\uc778 \ub2e4\ub2e8\uacc4 \uc811\uadfc\ubc95\uc740 \ud655\uc778 \ub2e8\uacc4\uc5d0\uc11c \ucd94\uac00\uc801\uc778 \ud2b9\uc131 \uaddc\uba85 \ub2e8\uacc4\ub97c \uac70\uccd0, \uc774\uc911\ud2b9\uc774\uc131 \ubd84\uc790\uc758 \uac01 \uac1c\ubcc4 \uae30\ub2a5 \ub3c4\uba54\uc778\uc5d0 \ub300\ud55c \ubc18\uc751\uc744 \ub9e4\ud551\ud574\uc57c \ud569\ub2c8\ub2e4.<\/strong><\/span><\/p>\n

    \uaddc\uc81c \uc900\uc218 \ud504\ub808\uc784\uc6cc\ud06c<\/h2>\n

    \uacac\uace0\ud55c \ubc14\uc774\uc624\ubd84\uc11d \ubc29\ubc95\uc744 \uac1c\ubc1c\ud558\ub824\uba74 \uad6d\uc81c \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc5c4\uaca9\ud788 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc8fc\uc694 \uac00\uc774\ub358\uc2a4\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n

      \n
    • \n

      ICH M10:<\/b> \ubc14\uc774\uc624\ubd84\uc11d \ubc29\ubc95 \uac80\uc99d \uac00\uc774\ub4dc\ub77c\uc778.<\/span><\/p>\n<\/li>\n

    • \n

      EMA \uac00\uc774\ub4dc\ub77c\uc778:<\/b> \uce58\ub8cc\uc6a9 \ub2e8\ubc31\uc9c8\uc758 \uc57d\ub3d9\ud559 \uc784\uc0c1\uc2dc\ud5d8 \uac00\uc774\ub4dc\ub77c\uc778(2017\ub144 \uac00\uc774\ub4dc\ub77c\uc778 7.4\uc808\uacfc \uac19\uc774 \uc81c\ud488 \uad00\ub828 \ubd88\uc21c\ubb3c\uc758 \uc0c1\uc138 \ud2b9\uc131 \uaddc\uba85\uc5d0 \ub300\ud55c \uad6c\uccb4\uc801 \uac15\uc870 \ud3ec\ud568).<\/span><\/p>\n<\/li>\n

    • \n

      FDA \uac00\uc774\ub358\uc2a4:<\/b> \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4 \uac1c\ubc1c \ud504\ub85c\uadf8\ub7a8 \uc0b0\uc5c5\uc6a9 \uac00\uc774\ub358\uc2a4(2021) \ubc0f 2019\ub144 \uac00\uc774\ub358\uc2a4 \ud504\ub808\uc784\uc6cc\ud06c(IV.A.3\uc808 \ud3ec\ud568).<\/span><\/p>\n<\/li>\n<\/ul>\n

      BsAbs PK \ubc0f \uba74\uc5ed\uc6d0\uc131 \uacfc\uc81c: Kymos\uc758 \uacbd\ud5d8<\/h2>\n

      BsAbs\ub294 \uad6c\uc870\uc801 \ubcf5\uc7a1\uc131\uacfc \uc774\uc911 \ud45c\uc801 \uacb0\ud569 \ud2b9\uc131\uc73c\ub85c \uc778\ud574 \uae30\uc874 \ub2e8\ud074\ub860 \ud56d\uccb4\uc5d0 \ube44\ud574 \ucd94\uac00\uc801\uc778 \ubd84\uc11d\uc801 \uacfc\uc81c\ub97c \uc81c\uc2dc\ud558\ub294 \uac83\uc774 \uc0ac\uc2e4\uc785\ub2c8\ub2e4.<\/span><\/p>\n

      \ub2f9\uc0ac\uc758 \uacbd\ud5d8\uc5d0 \ub530\ub974\uba74, \ubd84\uc11d\ubc95 \uac1c\ubc1c \uacfc\uc815\uc5d0\uc11c \uac01\ubcc4\ud55c \uc8fc\uc758\uac00 \ud544\uc694\ud569\ub2c8\ub2e4<\/strong>. \uc7a0\uc7ac\uc801 \ud45c\uc801 \uac04\uc12d\uc744 \ucca0\uc800\ud788 \ud3c9\uac00<\/strong>\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4. \ub610\ud55c \uac00\uc7a5 \uc801\ud569\ud55c \ubd84\uc11d\ubc95 \ud3ec\ub9f7\uc744 \uc120\ud0dd<\/strong>\ud558\uace0, \ud575\uc2ec \uc2dc\uc57d\uc744 \uba74\ubc00\ud788 \ud2b9\uc131 \uaddc\uba85<\/strong>\ud558\uba70, \uc6d0\ud558\ub294 \uc0dd\ubb3c\ud559\uc801 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0\uc11c \ucda9\ubd84\ud55c \ubd84\uc11d \uc131\ub2a5\uc744 \ud655\ubcf4<\/strong>\ud558\ub294 \uac83\uc774 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. <\/span><\/p>\n

      \ub2f9\uc0ac\ub294 BsAb \ud504\ub85c\uc81d\ud2b8\ub97c \ud1b5\ud574 \uc774\ub7ec\ud55c \ubd84\uc790\uc640 \uad00\ub828\ub41c \uc77c\ubc18\uc801\uc778 \uacfc\uc81c\ub97c \ub2e4\ub8e8\ub294 \ub370 \uc788\uc5b4 \uadc0\uc911\ud55c \uacbd\ud5d8\uc744 \ucd95\uc801\ud574 \uc654\uc2b5\ub2c8\ub2e4. \ud3ec\uad04\uc801\uc774\uace0 \uc138\ubd80 \uc9c0\ud5a5\uc801\uc778 \ubd84\uc11d \ubc29\ubc95\uc758 \uac1c\ubc1c \ubc0f \ucd5c\uc801\ud654\ub97c \ud1b5\ud574 \uacac\uace0\ud558\uace0 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 PK \ubc0f ADA \ubd84\uc11d\ubc95\uc744 \uad6c\ucd95\ud560 \uc218 \uc788\ub2e4\uace0 \ubbff\uc2b5\ub2c8\ub2e4<\/strong>. \uc774\ub294 \uc804\uc784\uc0c1 \ubc0f \uc784\uc0c1 \ud504\ub85c\uadf8\ub7a8 \ubaa8\ub450\uc5d0 \uc801\uc6a9 \uac00\ub2a5\ud55c \ucd94\uac00 BsAbs\uc5d0 \ub300\ud55c \ubd84\uc11d \ubc29\ubc95\uc758 \uc131\uacf5\uc801\uc778 \uac1c\ubc1c\ub85c \uc774\uc5b4\uc9d1\ub2c8\ub2e4. <\/span><\/p>\n

      Kymos Group\uc740 BsAbs \uac1c\ubc1c\uc744 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/h2>\n

      Kymos Group\uc740 \ubcf5\uc7a1\ud55c \ubc14\uc774\uc624\uc758\uc57d\ud488\uc758 \ubc14\uc774\uc624\ubd84\uc11d \ubc0f CMC \uc694\uad6c\uc0ac\ud56d\uc744 \ubaa8\ub450 \uc9c0\uc6d0\ud558\uae30 \uc704\ud55c \ud3ec\uad04\uc801\uc778 \ubd84\uc11d \uc5ed\ub7c9\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n

        \n
      • \n

        CMC \ubc0f \ubb3c\ub9ac\ud654\ud559\uc801 \ud2b9\uc131:<\/b> \ud56d\uccb4 \ud2b9\uc131 \uaddc\uba85, \ubd84\uc790 \ud06c\uae30, \uc11c\uc5f4 \uacb0\uc815 \ubc0f \ubbf8\uc0dd\ubb3c\ud559\uc801 \uc2dc\ud5d8.<\/span><\/p>\n<\/li>\n

      • \n

        \uae30\ub2a5 \ubc0f \uc5ed\uac00 \uc2dc\ud5d8:<\/b> ELISA \ub610\ub294 SPR\uc744 \ud1b5\ud55c \ud45c\uc801 \uacb0\ud569 \ubc0f \ub2e8\ubc31\uc9c8 \uc0c1\ud638\uc791\uc6a9, \uadf8\ub9ac\uace0 \uc138\ud3ec\ub3c5\uc131 \ubc0f \uc138\ud3ec \uae30\ubc18 \uc5ed\uac00 \ubd84\uc11d.<\/span><\/p>\n<\/li>\n

      • \n

        \uc804\uc784\uc0c1 \ubc0f \uc784\uc0c1 \ubc14\uc774\uc624\ubd84\uc11d:<\/b> \ub9ac\uac04\ub4dc \uacb0\ud569 \ubd84\uc11d(LBA)\uc744 \ud1b5\ud55c \uc57d\ub3d9\ud559 \uc218\uc900 \ud3c9\uac00.<\/span><\/p>\n<\/li>\n

      • \n

        PD \ubc0f \ubc14\uc774\uc624\ub9c8\ucee4:<\/b> \ub2e4\uc591\ud55c \uc0ac\uc774\ud1a0\uce74\uc778, \uc778\uc790 \ubc0f \uc778\ud130\ub8e8\ud0a8\uc744 \ucd94\uc801\ud558\uae30 \uc704\ud55c \uba40\ud2f0\ud50c\ub809\uc2f1 \uc5ed\ub7c9.<\/span><\/p>\n<\/li>\n

      • \n

        \uace0\ub3c4\ud654\ub41c \uba74\uc5ed\uc6d0\uc131:<\/b> \ucd1d \uacb0\ud569 ADA \ubd84\uc11d, \uc0c1\uc138 \ub3c4\uba54\uc778 \ud2b9\uc131 \uaddc\uba85 \ubc0f \uc911\ud654 \ud56d\uccb4(NAb) \uac80\ucd9c \ubd84\uc11d.<\/span><\/p>\n<\/li>\n<\/ul>\n

        \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\ub97c \uc704\ud55c \uc6d0\uc2a4\ud1b1 \uc194\ub8e8\uc158<\/h2>\n

        \ub2f9\uc0ac\ub294 PK, \uba74\uc5ed\uc6d0\uc131, \ubc14\uc774\uc624\ub9c8\ucee4 \ubc0f \ucca0\uc800\ud55c \uad6c\uc870 \ud2b9\uc131 \uaddc\uba85\uc744 \ud558\ub098\uc758 \uaddc\uc81c \uccb4\uacc4 \uc544\ub798\uc5d0\uc11c \ud3ec\uad04\ud558\ub3c4\ub85d, \uc804\ubb38 \uc804\uc784\uc0c1 \ubc0f \uc784\uc0c1 CRO \uc5ed\ub7c9\uc744 \uacb0\ud569\ud574 \ud504\ub85c\uc81d\ud2b8 \uc804 \uacfc\uc815\uc5d0 \ub300\ud55c \ud480\ud328\ud0a4\uc9c0 \uc9c0\uc6d0<\/strong>\uc744 \uace0\uac1d\uc5d0\uac8c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/span><\/p>\n

        \uacb0\ub860<\/h2>\n

        \uce58\ub8cc\uc6a9 \ud56d\uccb4 \uac1c\ubc1c\uc740 BsAbs\uc758 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1\uc744 \ud1b5\ud574 \uae30\uc874 \ub2e8\ud074\ub860 \ud56d\uccb4(mAbs)\uc758 \ud55c\uacc4\ub97c \uadf9\ubcf5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub4e4\uc758 \uc774\uc911 \ud45c\uc801 \uc791\uc6a9\uae30\uc804\uc740 \ubcf5\uc7a1\ud55c \uc9c8\ubcd1 \uacbd\ub85c\uc5d0\uc11c \ud6a8\uacfc\uc801\uc73c\ub85c \uc791\uc6a9\ud560 \uc218 \uc788\uac8c \ud569\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc774\ub7ec\ud55c \uace0\uc720\ud55c \ud2b9\uc131\uacfc \ubcf5\uc7a1\ud55c \uad6c\uc870\uc801 \uc544\ud0a4\ud14d\ucc98\ub294 \uc720\ud6a8\uc131\uacfc \uc548\uc804\uc131 \ud2b9\uc131 \ubaa8\ub450\uc5d0 \ub300\ud574 \ucca0\uc800\ud558\uace0 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc870\uc0ac\uac00 \ubc18\ub4dc\uc2dc \uc218\ud589\ub418\uc5b4\uc57c \ud568\uc744 \uac15\uc870\ud569\ub2c8\ub2e4. \ub354 \ub9ce\uc740 \uc784\uc0c1 \uc801\uc751\uc99d\uc744 \ud45c\uc801\ud654\ud558\uae30 \uc704\ud55c \uc0c8\ub85c\uc6b4 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \uc804\ub7b5\uc774 \uc9c0\uc18d\uc801\uc73c\ub85c \ub4f1\uc7a5\ud568\uc5d0 \ub530\ub77c, \uc774 \uc9c4\ud654\ud558\ub294 \ubd84\uc57c\ub294 \uac1c\ubc1c\uc758 \ubaa8\ub4e0 \ub2e8\uacc4\uc5d0\uc11c \uacac\uace0\ud55c \ubd84\uc11d \uc9c0\uc6d0\uacfc \ucca8\ub2e8 \uae30\uc220\uc744 \ud544\uc694\ub85c \ud569\ub2c8\ub2e4. <\/span><\/p>\n

        \ucc38\uace0\ubb38\ud5cc<\/h2>\n
          \n
        • \n

          Tetsuya Wakabayashi, Taichi Kuramochi (2025) \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\uc758 \ubc1c\uad74 \ubc0f \uac1c\ubc1c. Protein Expr Purif.<\/i> 2025 Dec:236:106787. doi: 10.1016\/j.pep.2025.106787. Epub 2025 Aug 5.<\/span><\/p>\n<\/li>\n

        • \n

          Ding Y, Andrien B, Sarkar M and Aimone M (2024). \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\ub97c \uc704\ud55c \uacf5\uc815 \uac1c\ubc1c, \uc81c\uc870 \ubc0f \uc784\uc0c1 \uc9c0\uc6d0: \ud654\ud559, \uc81c\uc870 \ubc0f \uad00\ub9ac(CMC) \uace0\ub824\uc0ac\ud56d. BioProcess International<\/i> 22(11\u201312). <\/span><\/p>\n<\/li>\n

        • \n

          Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) (2021). \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4 \uac1c\ubc1c \ud504\ub85c\uadf8\ub7a8 \uc0b0\uc5c5\uc6a9 \uac00\uc774\ub358\uc2a4. U.S. Center for Biologics Evaluation and Research (CBER) Pharmaceutical Quality\/CMC. <\/span><\/p>\n<\/li>\n

        • \n

          Choi et al. (2024). \uc2b9\uc778\ub41c \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\uc758 \uc791\uc6a9\uae30\uc804 \ubc0f \uc57d\ub3d9\ud559. Biomol Ther (Seoul)<\/i> 2024 Oct 25;32(6):708\u2013722. doi: 10.4062\/biomolther.2024.146. <\/span><\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

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