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CDMO Services

cGMP Manufacturing

cGMP Manufacturing of Therapeutics

iBio’s cGMP manufacturing facility was designed to provide highly flexible manufacturing schemes essential to the FastPharming® System.

  • Seamless scale-up by design with a pilot facility built as a true scale-down from at-scale manufacturing
  • Grams to kilograms production capacity
  • Gene to cGMP manufacturing in as little as 3 months
  • No scale-up issues impacting product quality or consistency often associated with bioreactors – the bioreactor unit is a single plant
  • Use of prefabricated modular cleanrooms for downstream purification processes
  • Robust systems monitoring and controls utilizing an integrated Rockwell Automation BMS

Seamless Process from Biomass Production to Purification

Downstream purification is performed in a series of prefabricated modular cleanrooms that provide iBio with unparalleled flexibility in downstream process train configuration without disruption to ongoing facility activities.

The FastPharming® System Provides

Manufacturing flexibility
Batch size adapted to needed scale

Easy scale-up
Each plant is a standalone bioreactor unit

Product quality and consistency
Elimination of scale-up issues associated with mechanical bioreactors