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Protein analysis to GMP

Eurosequence offers a broad range of individual protein analyses services, including most of the
analysis mentioned in ICH Q6B concerning the characterization of Biopharmaceuticals:

  • Protein Sequence Analysis using automated Edman degradation, on behalf of batch release
    testing as identification test  /check for impurities or presence of truncated forms

  • Amino Acid Analysis (AAA) for protein concentration or molar extinction coefficient
    determination or to check purity / composition / molar ratios of amino acids

  • N-, C- and internal sequence analysis using automated Edman degradation and/or MS/MS,
    after digestion or cleavage of the protein, and/or selective isolation of fragments like the
    C-terminal peptide

  • C-terminal sequence analysis by selective isolation of the C-terminal peptide from a protein
    digest followed by its characterisation, or by carboxypeptidase / AAA experiments

  • Identification of post-translational modifications e.g. acetylation, glycosylation,
    phosphorylation, etc.

  • Disulphide bridge analysis using combined techniques; Edman degradation and MS/MS

  • Peptide mapping / LC profiling or LC-MS

  • Molecular weight  by (LC-)MS or MALDI-TOF MS

  • Impurity profiling by LC analysis like RP-HPLC, SEC-HPLC

  • Aggregation analysis by SEC-HPLC

  • Product related impurities analysis like caused by deamidation, oxidation, mismatched
    S-S bridge forms (scrambled forms)

  • Host cell derived impurities / Process related impurities analyses

  • Unique Service Determination of peptide length and their relative abundances in (very)
    complex mixtures like protein hydrolysates; Development of hypo-allergenic (baby) food 

All in accordance with ICH guidelines  (ICH Q6B)

ICH Topic Q6B outlines procedures for proteins and peptides like recombinant
proteins, glycoproteins, antibody products and/or synthetic peptides.