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.