August 21, 2014

A 21st Century Process for Design of Chromatography Media


A new cation exchange chromatography medium (resin) has been investigated using quality by design (QbD) tools during chemical design and functional evaluation. The combined effect of variations in medium properties and chromatographic variables in a monoclonal antibody (MAb) purification process has been estimated by design of experiments (DoE), employing a D-optimal design. The future process variability, based on realistic variations in the studied factors, was estimated by Monte Carlo simulations.

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