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[´ã´ç¾÷¹«] 1) Á÷¹«: Ç×ü ¹× ADC ºÐ¼® ¿¬±¸ |
2) ÀÚ°Ý¿ä°Ç - Àü°ø : »ý¸í°øÇÐ/»ýÈÇÐ/»ý¹°ÇÐ/ºÐÀÚ»ý¹°ÇÐ/ºÐ¼®ÈÇÐ/¾àÇ°ºÐ¼®/¾àÇÐ µî °ü·Ã Çаú - Çз : ¼®»ç/¹Ú»ç - °æ·Â : 3³â~12³â 3) ¿ì´ë»çÇ× - ¿µ¾î È¸È °¡´ÉÀÚ - Cell-based assay °³¹ß ¹× ¹ë¸®µ¥ÀÌ¼Ç /
Cell-culture ½ÇÇè½Ç ±¸Ãà °æÇèÀÚ - IND, BLA °æÇèÀÚ - ºÐ¼®¹ý ±â¼úÀÌÀü °æÇèÀÚ - Á÷¹«°ü·ÃºÐ¾ß °æÇèÀÚ ∙ Ç×ü ¶Ç´Â ADC ºÐ¼® ¿¬±¸ °ü·Ã Àü¹® Áö½Ä º¸À¯ : Bioassay (Binding assay,
cell-based assay µî), Purity (Size
variants, charge variants µî), Characterization, Safetyµî ∙ Ç×ü ¶Ç´Â ADC ºÐ¼® ¿¬±¸ °ü·Ã ºÐ¼® ±â¼ú °æÇè : CE, iCIEF, Bioassay, ELISA, Host
cell DNA, Host cell protein, Peptide mapping, PTM analysisµî ∙ Ç×ü ¶Ç´Â ADC ºÐ¼® Àåºñ »ç¿ë °æÇè
: LC (HIC, SEC, IEX µî), LC-MS/MS, GC, UV, ELISA Microplate reader, CE-SDS,
iCIEF, qPCR µî |
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