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제목 ADC Manufacturing .IND Service(US FDA,EU EMA, etc)
작성자 관리자
작성일자 2024-07-02
조회수 206
**ADC CDMO Service :GMP Manufacturing 과 IND/NDA (US FDA, EU EMA,etc) 까지
       국제규격에 맞게 CDMO, IND , Marketing등 가능합니다.

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


1) Monoclonal antibody : Cell Line Development to GMP Manufacturing
    * PayLoad & Linker Manufacture(pre-GMP & GMP)
    * Synthetic Payloadc Linker:Peptides, Oligonucleotides, PEGs, Cytotoxic drugs,etc
    * Testing and Release, Stability Study, Manufacturing(DS,DP), Registration (CMC, etc)

   --Bioconjugation , purification process development to GMP Manufacturing

    * ADC, PDC, SMDC, etc Conjugates
             --Fill & Finish, Stability Study, CMC, Registration


2) Oligonucleotides, Small molecules, Biologic conjugates.
     -- Monoclonal Antibodies, Bi-Specific Ab &  FC-Fusion Proteins
     --Recombinant Proteins
     --Protein Vaccines
     --Plasmid DNA


* IND/NDA (FDA, EMA,etc) adadt on Global regulations.
     --Inspection
     --CMC filling support, etc


* Development--Manufacturing-Analytical-Registration--Licence out, Marketing
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