GMP

GMP

QC System

QC System In order to provide the best quality media possible, Xcell Therapeutics follows a strict quality control process from the early stages of purchasing and supplier qualification to storage and shipping solutions.

Xcell Therapeutics Inc. QC System follows the international standards listed below.
  • Regulation on Good Manufacturing Practices (GMP) for Medicinal Products (MFDS)
  • FDA 21 Code for Federal Regulations (CFR) Parts 210 and 211, cGMP (current Good Manufacturing Practice)
  • EU GMP EudraLex – Volume 4 – Good Manufacturing Practice (GMP) Part 1
  • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • ISO9001 Quality Management Systems (Planned)
    ISO 13485 Medical Devices Quality Management Systems
Quality
System

MANUFACTURING AREA

cGMP PRODUCTION FACILITY

Cascade Clean Room Structure (Highest Level: ISO5)

MANUFACTURING EQUIPMENT

Mixing System
  • 10L, 50L, 100L, 200L size homo-mixing system
  • Single-use liner bags ( ~ 100 Liter) or Multi-use SUS tank (200 Liter)
Sterilizing System
  • Sterilizing filter and transfer system (single-use type)
  • Isolator or Class Ⅱ Type A2 Biosafety Cabinet for aseptic manufacturing process
Filling & Capping System
  • Semi-automatic aseptic filling system
  • Semi-automatic aseptic capping system
Labelling & Packaging System
  • Automatic labelling system
  • Automatic film shrinking system
Freezing System
  • Temperature controlled product freezing system (below -70℃)
Storage System
  • Temperature controlled product storage system (below -20℃)
Water System
  • Water manufacturing and monitoring system (Water for Injection grade)

QUALITY CONTROL SYSTEM

  • Physicochemical Analysis System

    • Osmolality test
    • Conductivity test
    • pH measurement
    • Total Organic Carbon (TOC) test
  • Microbiological Analysis System

    • Sterility test
      – Membrane filter system
    • Mycoplasma test
      – Polymerase Chain Reaction
    • Endotoxin test
      – Kinetic assay system
  • Biological Analysis System

    • Performance assay - Cell culture test
    • Enzyme-Linked immunosorbent assay(ELISA)
    • Flow cytometry
    • Tri-lineage differentiation test
    • Cell Proliferation test

LOGISTICS

  • Cold Chain Delivery System

    • Qualified single(or multi)-use thermal packaging solution (below -20℃) with PCM pack
  • Temperature Monitoring System

    • Continuous temperature monitoring by temperature data logger during distribution