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Á¦¸ñ Cell therapy capabilitiy from IIT , pre-clinical and IND stages (CAR-T, CAR-NK,MSC and iPSC)
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ÀÛ¼ºÀÏÀÚ 2024-09-27
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Cell therapy  capabilitiy from IIT , pre-clinical and IND stages)

*Different gene vectors
   : Plasmid, Lentivirus, mRNA, Adeno-associated virus, etc..

1) CAR-T CRO&CDMO


2)CAR-NK CRO & CDMO , PBMC derived CAR-NK/NK therapy


3)iPSC CRO&CDMO Service


4)MSC-Based Cell Therapy CDMO


* GMP Facility Compliant under FDA CFR PART21 AND ATMPs Regulations.


** Experienced in CMC Studies for Global IND Application & GMP Manufacturing for IIT and Clinical Trials
  : T cell projects / Cell and gene therapy projects

** Experienced in Integrated IND Application Service (Succeeded in IND Applications),Acquired US IND approvals.
      --Possible IND filling U.S and Europe.

    I) From plasmid to cell therapy products (Plasmid, Lentiviral Vectors, Cell therapy Products): acquiring  IND approvals assisted.
                   * Timeline from microbial banking to first cell product primary batch : 7 months .
    II)Process development and GMP manufacturing--Analytical development & qualification--Quality control and stability study--
               Preclinical assessment and clinical trial protocol draft--Revision of materials of IND--Application


 (Service)
 * Preclinical stage--IND filling(IS , Europe)--Clinical stage--BLA application--Commercialization(cGMP cell therapy manufacturing)

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