Chromacon

Impurity Isolation using N-Rich

Application example

Biosimilar interchangeable claims require comparison, of product-related impurities with the licensed reference product. Knowing product-related molecular variants requires isolating sufficient quantities of eg truncated, modified or aggregated forms for characterization. Without N-Rich, these investigations require tedious and repetitive purification procedures using analytical high resolution FPLC/HPLC with low loading capacity. N-Rich eliminates this bottleneck by combining the capabilities of preparative chromatography with the high resolution of a cyclic enrichment and polishing process.

The capabilities of the N-Rich technology are shown in an application note for isolating antibody isoforms or product-related impurities of a synthetic peptide. Isolation time was cut from more than 30 days, as required with conventional approaches, down to only 3 days, yielding quantities of 1.5 mg to 8 mg isolated proteins with purities of 75% to >90%.

Application areas of N-Rich

  • Isolation of product-related impurities for
    • Biosimilar characterization
    • Active Pharmaceutical Ingredient (API) characterization
    • Antibody-drug conjugate isoform characterization
    • Studying isoform stability as a function of time and/or formulation
  • R&D applications, including
    • Identification of biomarkers and compounds in proteomics and metabolomics research
  • Generation of ultra-pure compounds for
    • protein crystallography
    • reference materials

Basic principle of N-Rich

N-Rich is an automated 3-step process using two columns to enrich, purify and elute a desired compound from a complex mixture.

Process principle of N-Rich leading to an enrichment, purification and separation of target compounds.