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
