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Services
End-to-End CDMO Services based on technological Expertise

Quality Management
Quality Management
KOLON Biotech has a rigorous quality management system with experienced teams of QA and QC professionals
to ensure identity, purity, stability and potency of the cell and gene therapy and exosome therapy products.

System

Our GMP system meets the domestic and international regulations
service service
GMP Compliance
  • Compliance with cGMP requirements
  • MFDS certification and FDA Drug Establishment Registration
  • Adherence to PIC/S, WHO and ICH guidelines
service service
SOPs
  • Facilities/Equipment
  • Production
  • Materials
  • Laboratory control
  • Packaging & Labeling
  • Documents

QC Tests

We can provide various type of QC test and Characterization Method for cell and gene therapy and exosome therapy.
Test item
example
Selective examples
Safety Mycoplasma Test (MFDS)
Sterility
Endotoxin
Potency and Identity Potency
Cell Counting & Viability
Real Time PCR test
PCR test
Residue Test
Physical characterization
Physical character-ization
 Visual Inspection of Particulates Test
Determination of Volume of Injection in Containers
Particulate Matter
Filter integrity
Leak Test(USP)
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