CDMO services

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Contract Development and Manufacturing (CDMO)

  • Overview
  • GMP Facility
  • Quality Management System

GMP manufacturing and quality control expertise

Introduction to GMP Manufacturing Facility

[GMP Facility 1] Cell Therapy
Location

Seoul, Gangnam-gu,

Area 580m²
CAPA Production 116 units (based on Cellstack containers) / 73,776㎠ (based on surface area)
Storage 110,800 vials (vial-based) / 4,500 bags (bag-based)
Structure
  • Sterile Processing
    Rooms 1, 2, 3, 4
  • Sterile Processing
    Room A, B
  • QC Lab
  • Storage
Application Clinical-grade cell and gene therapies (Naïve / Pre-conditioned / Gene-modified MSC, T cell, NK cell)
[GMP Facility 2] Cell & Gene Therapy
Location Hanam, Gyeonggi Province Area 3,443㎡
CAPA Production 198EA(based on Cellstack containers) / 125,928㎠ (based on surface area)
Storage 260,800 vials (vial-based) / 10,800 bags (bag-based)
Structure
  • Positive Pressure GMP
  • Positive Pressure GMP
  • QC Lab
  • Storage
  • Office Area
Application Clinical-grade cell therapies (Naïve / Pre-conditioned / Gene-modified MSC, T cell, NK cell)
[Exterior view of GMP facility 1 & 2]
[GMP Facility 3] Gene Therapy
Location Hanam, Gyeonggi Province Area 1,161 m²
CAPA Raw Materials 20 Lots/Year (1x10¹² vg/ml)
Finished Products 20 Lots/Year (10,000 vials/year)
Structure
  • Negative Pressure GMP
  • Viral Vector(DS, DP)
  • Gene Therapy
  • Fill & Finish
Application Clinical-grade gene therapies (Viral Vectors: Lentivirus, Adeno-associated virus, Adenovirus)
Key Features Airborne Particle Control System, Separate Biopharmaceutical DP Production, Single-Use & Closed Systems
[Exterior view of GMP facility 3]