Process characterization is key for fully understanding products and processes, establishing state-of-the-art manufacturing processes, and addressing associated process control strategies as well as any potentially critical parameters.
We establish scale-down models for fermentation concepts, chromatography, tangential flow filtration (TFF), etc. for (among other things):
Proven acceptable/normal operation range (PAR/NOR) studies for USP
Proven acceptable/normal operation ranges (PAR/NOR) studies for DSP
Design of experiment (DoE) tools can be used, for instance in PAR/NOR studies, to obtain as much information as possible on parameter interactions, process impacts, and process-associated control strategies.
Impurity removal studies of:
The findings can flow into risk assessments and/or process control strategies and/or process validation studies. This additional knowledge can then be applied to improve process robustness and product safety while production is being scaled up to serve the market.