CDMO Services

cGMP Manufacturing

cGMP Manufacturing of Therapeutics

iBio's cGMP manufacturing facility was designed to provide highly flexible production schemes.

  • Seamless scale-up by design with a pilot facility built as a true scale-down from manufacturing
  • Grams per batch to hundreds of kilograms per campaign production capacity
  • Gene to cGMP manufacturing within 8 months
  • Product quality and consistency remain unchanged as production scales-up – the bioreactor unit is a single plant
  • Use of a series of prefabricated modular cleanrooms for downstream processes and fill/finish
    • Complete system control utilizing Rockwell Automation 

Seamless Process from Biomass Production to Purification

Downstream purification is performed in a series of prefabricated modular cleanrooms, designed and built by G-CON. The clean rooms provide iBio with unparalleled flexibility in downstream process train configuration, permitting reorganization and rapid reconfiguration without disruption to ongoing facility activities.

The FastPharming® Expression System Provides

  • Manufacturing flexibility - Batch size adapted to needed scale
  • Easy scale-up - Each plant is a standalone bioreactor
  • Product consistency throughout - Product quality and consistency maintained during scale-up