Bulk GMP Lyophilization

LSNE Contract Manufacturing is a recognized GMP lyophilization service provider, dedicated to producing quality products and offering timely service.  LSNE’s three integrated manufacturing facilities allow for both aseptic and non-aseptic processing of up to 400 liters per batch of bulk product material in virtually any tray or mold configuration.

Since 1997, LSNE has been providing bulk GMP lyophilization services for both intermediary and final product presentations, securing an extensive manufacturing history of processing biologics and small molecules.  We offer bulk GMP lyophilization under ISO 5 or ISO 8 conditions to meet your endotoxin and bioburden requirements.

By contracting the experience and expertise of LSNE’s development team to optimize your formulation and/or lyophilization cycle, we can help you reach optimal bulk freeze-drying results. We do this by performing differential scanning calorimetry and freeze dry microscopy analysis and utilizing the knowledge of our development group.  LSNE can meet your company’s requirements while producing quality, low moisture lyophilized product that can be easily transferred to our GMP lyophilizers.

 

Bulk GMP Lyophilization Units:

  • 316L Stainless Steel internal construction
  • Gas back-fill capability
  • Redundant vacuum pumps and compressors
  • Heating and cooling rate of shelves 1°C/minute
  • Steam defrost of condensers

Tray Options:

  • Disposable Gore Lyoguard trays
  • Disposable Gore Lyoguard RD containers
  • Custom Manufactured 316L Stainless Steel Trays