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.

This might interest you

We offer you our strong expertise in developing strains based on E.coli host systems to produce peptides, proteins (soluble and insoluble), plasmid DNA products, and vaccines.

USP and DSP teams work hand-in-hand to speed up process development and make every project a success.

Richter BioLogics operates two multipurpose facilities for manufacturing biological drug substances with microbial expression systems.