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

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.