Process Development & Optimization

Fermentation Development

AFI uses cutting edge technology to provide reliable and robust R&D services throughout the entire life cycle of API development. Staff in Development Fermentation use shake-flask data from Microbiology as a starting point to develop fermentation processes for our production facility. Processes are developed in our lab-scale (20 litre) fermentation vessels. Modifications are made to media recipes to suit fermenter operations. Cultivation in stirred fermenters offers the possibility of much greater process control than is the case in shake flasks. Temperature, pH, dissolved oxygen, agitation, airflow, head pressure can all be controlled; depleted nutrients can be replaced by fed batch operation. Physical and chemical parameters need to be optimized for growth and productivity. All our vessels are controlled by digital controllers interfaced with computers for continuous acquisition of online data and for process control. Development work at all stages is carried out in close cooperation with Organic Chemistry staff as operational changes in fermenters can have a profound effect upon impurity profiles of crude broths, making downstream operations easier or more difficult.