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1) Á÷¹«: Ç×ü ¹× ADC ºÐ¼® ¿¬±¸

- Á¤¼º ¹× Á¤·® ºÐ¼®¹ý °³¹ß

- ºÐ¼®¹ý ¹ë¸®µ¥À̼Ç

- Ư¼º ºÐ¼®

- CDMO ºÐ¼®¹ý ±â¼úÀÌÀü

- CDMO °ü¸®



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 ÀÌ»ó



3) ¿ì´ë»çÇ×

- ¿µ¾î ȸȭ °¡´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

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~10³â

    

3) ¿ì´ë»çÇ×

- ¿µ¾î ȸȭ °¡´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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