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National Center for Stem Cell and Regenerative Medicine (NCSR)

Update

2026-03-13

National Center for Stem Cell and Regenerative Medicine (NCSR)

The GMP Manufacturing facility

The GMP Manufacturing facility which is belonged to the National Center for Stem Cell and Regerative Medicine (NCSR) was opened in 2016 to accelerate clinical research of the stem cell and regenerative medicine field. In addition to manufacturing and distribution of iPSC sources that can be used for clinical research, we support manufacture of cell therapeutics for clinical research. Recently, by starting a GMP training course for manufacture of advanced regenerative therapeutics, we expect that the GMP market will be facilitated.

Process

  • GMP Manufacturing and Supply of GMP Grade hiPCS Cell lines
  • Contract Manufacturing Service of Cell Therapeutics for Clinical Research
  • Contract Quality Test Service of of Cell Therapeutics for Clinical Research

Detailed Service

  • GMP Manufacturing of Cell Therapeutics for Clinical Research
  • GMP Quality Test of Cell Therapeutics for Clinical Research
  • MCB/WCB Banking of Cell Therapeutics for Clinical Research
  • GMP Training
  • GMP Consulting

GMP Manufacturing Facilities

  • Total area : 5,181㎡ (5 story building)
  • GMP area : 1,620㎡ (3rd floor)
GMP Manufacturing Facilities - Floors, Cell Name
Floors Cell Name
5 AHUs
4 Maintenance Floor
3 Production, QC Lab., Warehouse
2 Cell Bank, R&D Lab., Office
1 Meeting room, BMS room
B1 Mechanical, Electrical

GMP Manufacturing Facilities

Procedure for GMP Manufacturing Service

  • Researchers who plan for clinical study for cell therapeutics apply for the manufacturing service
  • Committee of GMP manufacturing facility reviews the plan
  • If the plan is accepted, researcher and NCSR makes contract for the manufacturing
  • After review and transfer of manufacturing process, NCSR progresses the process validation and manufacturing

Requirements to Apply

  • Verified data for safety and efficacy of products at GLP facilities
  • The Completed GMP manufacturing process and analytical methods
  • Period of manufacturing processes not exceeding nine (9) months
  • Preparedness to start clinical study within one year after finishing manufacturing of products

Steps to Apply

  1. 1

    Interview
    By e-mailing,
    Calling or visiting

  2. 2

    Pre-review
    Review of utilization plan
    (Draft)

  3. 3

    Review and Approval
    Registration and Evaluation
    of Utilization Plan
    (By Review Board Members)

  4. 4

    Contract
    Contract signing and
    provision of GMP Service
    (Post-monitoring of service goals)

Criteria of Approval

  • Suitability of Utilization Plan
  • Competency of Processing Techniques
  • Possibility of Practical Application
  • Relevance of Outcome Utilization
  • Ripple Effect of Regenerative Medicine

Major GMP Equipment

Major GMP Equipment - Division, Species, Amounts
Division Species Amounts
Utility HVAC System, Gas System, BMS, TMS, PMS, LN2 System, etc. 45
Process BSC, CO2 Incubator, Centrifuge, RP Microscope, CRF, etc. 104
QC Fluorescent Microscope, FACS, Endotoxin Analyser, RT-PCR, Cytometer, NAE, Air Particle Counter, Air Sampler, etc. 71
Storage LN2 Tank, Cell Storage Tank, Deep Freezer, Refrigerator, Freezer, etc. 23
Total 243

Time to Apply

Anytime throughout the year
Please contact the National Center for Stem Cell and Regenerative Medicine (NCSR)

  • e-mail : jylee2310@korea.kr
  • Phone : +82-43-249-2533
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