Automated Process of Enriching of Side Fraction/Impurity – A Unique Isolating Technique for QC/QA

In the development of therapeutic peptides and proteins, the characterization of product-related impurities is required by ICH Q6B and ICH Q3A (R2) guidelines. The preparation of analytical standards and preparative isolation of product-related impurities is a laborious task. N-Rich is a preparative twin-column chromatography process for fast automated enrichment and isolation of minor compounds from complex samples operated by the Contichrom system. This presentation provides an introduction to the process principle of N-Rich and shows application examples for monoclonal antibody charge isoform isolation and peptide impurity isolation.
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