1. 연구개발 개요 핵심분야로서 산업화의 주역이 될 것으로 …

1 1. 1990 erythropoietin (EPO), colony stimulating factor (CSF), 20-30% 21 . 70% . , , , , . , (1) , , , , (2) , , , . , , , . (1) host , (2) fluorescence activated cell sorter (FACS) , (3).

2 , . 2.. , , .1,2,3 , GMP , , , . O O O O O O O O O O O O O O O O 1. , 1 3 . , / FDA Chinese hamster ovary (CHO)/DHFR .4,5 2 DHFR methotrexate (MTX) MTX DHFR ,6,7 limiting dilution.

3 8 , MTX , , , , , subcloning . , . (1 ) . CHO/DHFR- Cotransfection ofexpression vectors1st selection2nd selection(limiting dilution)..MTX level [A] nM [B] n M [C] nM[D] nM[F] producerat each level of MTX 2. MTX (1) , (2) , prion .10.

4 , host , host . 1) host , (2) , FACS fluorescence in situ hybridization (FISH) , , 3) . CHO . , , . EPO35 Amgen, Sankyo.

5 Ortho Biotech, ChugaiHuman insulin18 Eli Lily, Novo NordiskG-CSF16 Amgen, Hoffmann-La Roche, Sankyo, ChugaiHuman growth hormone15 GenentechInterferon-alpha11 ScheringPlough, Roche, Sumitomo 2800 , 130 . EPO, CSF, , . 70% , . 1997 1 . 21 , 2000-2010 12% 2010 500 .12 , 1997 10 1 40 , genome project . , , . , , . 2004 3000.

6 13 , , , .. , , (post-translationalmodification) 21 . , . , , , , .. ( ) (technology life cycle) ? . CHO/DHFR , 1981 Colombia Chasin , Amgen, Genentech EPO, CSF, , tPA . 6 FDA , 60 .14,15 Kirin Chugai EPO CSF , tPA.

7 16 1996 super-CHO NSW Gray .17 , ETH Bailey bcl-2 1998 Nature Biotechnology ,18 Suzuki ,19 Al-Rubeai .20 1991 Celltech CHO/GS system ,21 Genentech bicistronic vector doubleselection .22,23 1999 Genetics Institute host .24 2000 Genentech green fluorescence protein(GFP) .25 EPO , , LG .. LG, , , , , . 10 CHO , , FISH , , , ( 5 27 , 1 , 2 ).

8 ( ) 3 , LG EPO , , ( ) thrombopoietin (TPO) . host . , 10 , .. , 2 . , , . , bcl-2 (Americal Chemical Society, N. S. Kim, G. M. Lee, 2000 3 ), host . host.

9 , , , . genome project , , , .. ? (Royalty) , ? , . , host.