Scale-Up

Fermentation Pilot Plant

During the research and development phase, API scale up to full scale equipment (up to 30,000 litres at AFI) is facilitated by trials in our intermediate pilot scale fermenters (150, 300 and 1500 litres). Our fermenters are controlled by digital controllers interfaced with computers for continuous acquisition of online data and for process control. Data from pilot scale trials is used as the basis for design of full scale manufacturing processes. Standard scale up equations are used to predict full scale operating parameters such as agitation and airflow. Pilot scale fermenter trials also serve to provide larger quantities of fermentation broth for downstream pilot scale development.  Fermentation Pilot Plant is also equipped with pilot scale cell separation equipment including a filter press, disc stack centrifuge and hollow fiber filtration skid.

Pilot scale equipment may also be used for supply of GMP product to support early the clients early development and clinical trials activities.