R&D

R&D

GMP

  • Quality System
  • Manufacturing
  • GMP Facilities
  • Quality Control

Quality System

For safe and innovative cell therapy products production, we have established GMP Quality Compliance in accordance with international standards with documentation systems based on 6 GMP Systems (Quality, Quality Control, Production, Facilities and Equipment, Materials, and Validation System) under the Quality Management System.

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Manufacturing

We have both an aseptic culture room and an aseptic filling room for the production of allogeneic NK cell therapy products & autologous T cell therapy products and have applied Closed & Semi-Automated Culture System for safe & aseptic production of cell therapy products in large quantities.

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GMP Facilities

We can produce safe products by supplying stable pharmaceutical water via installing PW & WFI manufacturing and distribution systems, maintaining temperature/humidity with dedicated HVAC Systems at workplace, and fundamentally preventing cross-contamination by cleanliness and differential pressure management.

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Quality Control

We have separate Laboratories for Physic.&Chem., Bioassay, Sterility Test, Microbial Test as well as Virus Test allowing all tests related to products and environmental monitoring of the manufacturing area varying from raw material to release & stability test by ourselves.

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