Antibody and Biopharmaceuticals
Eurosequence offers its broad range of experience with individual protein analyses services, including the most important analyses mentioned in ICH Q6B concerning the characterization of Biopharmaceuticals. For antibody analysis, we offer both individual analyses or a complete package, tailored to the FDA and ICH guidelines and available to GLP/GMP, including:
- N-terminal sequence analysis using automated Edman degradation, either on individual LC and HC, after separation/ isolation (and de-blocking, if necessary), or on intact antibody, or both.
- Amino acid composition analysis for protein concentration or molar extinction coefficient determination or to check purity and molar ratios of amino acids
- 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, or selective peptide mapping followed by (LC) MS/MS
- Peptide mapping MS analysis for further characterization and structure confirmation using several digestions and MS techniques
- Complete sequence analysis using several digestion strategies and combined MS and Edman degradation techniques
- Disulphide bridge analysis using combined techniques; Edman degradation and MS/MS peptide mapping
- Identification of post-translational modifications glycosylation sites, etc.
- Identification product-related impurities S-S bonds mis-matched, degradation products, oxidation, etc.
- Molecular weight by (LC-)MS or MALDI-TOF MS after de-glycosylation
- Impurity profiling by LC analysis like RP-HPLC, SEC-HPLC
- Aggregation analysis by SEC-HPLC