PROCESS CHARACTERIZATION SERVICES

UNDERSTANDING PROCESSES IS ESSENTIAL

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

TO DOE OR NOT TO DOE?

Overlay on column/resin life time testing (elution profiles)

We establish scale-down models for fermentation concepts, chromatography, tangential flow filtration (TFF), etc. for (among other things):

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.