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Lyophilization

Samsung BioLogics is equipped with a novel, state-of-the-art Fill and Finish facility with aseptic filling, lyophilizers with automated loading and unloading, and capping integrated within a Restricted Access Barrier System (RABS). All processes are cGMP compliant and are validated to meet customer and regulatory requirements. Samsung BioLogics’ dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production.

Samsung's drug product facility is designed to meet
all FDA and EU Annex 1 requirements for Sterile Drug Product Manufacturing

Lyophilization

Lyophilization image 1 Lyophilization image 2
  • Lyophilization image 1
  • Lyophilization image 2
Lyophilization Specifications items include Lyophilization, and so on.
Lyophilization
Equipment
  • Two(2) Lyophilizers
Capacity/Capability
  • Max. loading capacity : 32,000 vials (10ml) per lyo
  • Ice load capacity : 300kg
  • Shelf Area: 16.7 ㎡
  • Automatic loading and unloading system with RABS
Lyophilization Specifications items include Lyophilization, and so on.
Lyophilization
Equipment
  • Two(2) Lyophilizers
Capacity/Capability
  • Max. loading capacity : 32,000 vials (10ml) per lyo
  • Ice load capacity : 300kg
  • Shelf Area: 16.7 ㎡
  • Automatic loading and unloading system with RABS

Lyophilization Cycle Development

  • Lyophilized product design
  • Product Characterization
    • Thermal characterization of product (Tg, Tg’, Teu,Tc)
    • Characterization of freezing step (crystalline or amorphous)
  • Finished product analysis specific to lyophilized products
    • Karl Fisher moisture
    • Physical appearance
    • Attributes of constituted solution (time, clarity, PM)
  • Lyophilized formulation development support
  • Manufacturing of small-scale batches for development stability
  • Troubleshooting commercial processes
  • Product Impact assessment