Model and Kinetic Parameters Identification for Therapeutical Product Obtained According to the GMP Guidelines

The technological solutions were elaborated to achieve the design of the production flow with respect of the Good Manufacturing Practice (GMP) guidelines. To be in line with the GMP rules a fed-batch operation mode is be designed based on the batch modelling results. As the production rate of the microbial immunomodulator is associated with the biomass growth rate, it was required to study the bacterium growth kinetics in batch process. After the selection of the kinetic model based on several batches experimental data by using the analysis criteria - modelling error and estimation rule convergence, the limiting substrate concentration to be maintained during fed-batch cells exponential growth was determined as 115 - 125 mg/L. The batch bioprocess was performed in a Bioengineering AG bioreactor with a software based control of the main variables.