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ADC CDMO Service(US FDA,EU EMA, PDMA, NMDA)
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2024-07-02
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44
**ADC CDMO Service :GMP Manufacturing °ú IND/NDA (US FDA, EU EMA, PDMA, NMDA) ±îÁö
±¹Á¦±Ô°Ý¿¡ ¸Â°Ô CDMO °¡´ÉÇÕ´Ï´Ù.
1) Monoclonal antibody : Cell Line Development to GMP Manufacturing
PayLoad & Linker
--Bioconjugation Development to GMP Manufacturing
2) Mammalian Cell lines, Microbial Cell lines
-- Monoclonal Antibodies, Bi-Specific Ab & FC-Fusion Proteins
--Recombinant Proteins
--Protein Vaccines
--Plasmid DNA
* IND/NDA (FDA, EMA, PDMA,NMDA °¡´ÉÇÕ´Ï´Ù.)
--Inspection Experience
--DNA to NDA.BLA one-stop solution
* Development--Analytical-cGMP Manufacturing
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