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제목 ADC Manufacturing .IND Service(US FDA,EU EMA, Pmda,etc)
작성자 관리자
작성일자 2024-07-02
조회수 101
**ADC CDMO Service :GMP Manufacturing 과 IND/NDA (US FDA, EU EMA, Pmda,etc) 까지
       국제규격에 맞게 CDMO, IND 가능합니다.

**Available , accord to your request of Manufacturing, IND/NDA , besides written this brief example.


1) Monoclonal antibody : Cell Line Development to GMP Manufacturing
    * PayLoad & Linker Manufacture(pre-GMP & GMP)
    * Synthetic Macromolecules:Peptides, Oligonucleotides, PEGs, etc
    * Testing and Release, Stability Study, CMC Dossier

   --Bioconjugation Development to GMP Manufacturing

    * ADC : Tox & Clinical Batches Manufacture(pre-GMP & GMP) and Release Testing
             --Fill & Finish, Stability Study, CMC Dossier


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,NMDA ,etc) adadt on Global regualtions.
     --Inspection
     --DNA to NDA.BLA one-stop solution(15Months US Filing, For example)


* Development--Analytical-cGMP Manufacturing
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