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
- Temperature, DO, pH seed / main
- Feed rates / growth rates
- Induction point / OD, induction temperature / inducer titer
Proven acceptable/normal operation ranges (PAR/NOR) studies for DSP
- Dynamic resin binding capacity, ligand density (chromatography)
- Bed height, gradient slope, flow rate (chromatography)
- Membrane load, TMP, concentration / diafiltration factors (TFF)
To DoE or Not to DoE?
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.
Lifetime studies
- Resins/columns
- TFF membranes (cassette/hollow fiber)
Impurity removal studies of:
- Process-related impurities like antifoam agents, host cell proteins, host cell DNA, etc.
- Product-related impurities like product isoforms (oxidized, deamidated, truncated, forms, etc.)
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.