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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
External and internal images of iBio's cGMP contract manufacturing facility

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.
two manufacturing staff members moving a tray of plants used in iBio's facility for CDMO services

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

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