PROCESS DEVELOPMENT
Process development is a critical step needed to optimize the performance of manufacturing systems. The CRI uses several protein expression systems such as Pichia pastoris, Escherichia coli, Bacillus anthracis and mammalian cells (CHO cells, hybridoma cells) in order to obtain proteins of interest that are potential drug candidates for testing in Phase I clinical trials.
During process development, standard operating procedures are written for GMP production and scale-up. For process development, three 7 L fermentors, two AKTA protein purification systems, a HPLC system and tangential flow filtration system are used. Drug candidates are produced according to the written SOPs in a GMP-compliant environment. The GMP production includes documentation, raw material purchase, cell banks, cultivation of protein expression systems in fermentors/bioreactors, protein purification, filling, storage and distribution.