Peptide products present unique and difficult structural characterization challenges (e.g. confirmation of the disulfide bridge structure in Linaclotide orĀ  an assessment of fatty acid acylation in Liraglutide). BioPharmaSpec has developed and qualified analytical solutions for ICH compliant peptide characterization.

For peptide products with a single defined sequence, BioPharmaSpec has developed methods to provide in-depth information for the product and any product-related impurities.

For generics of heterogeneous peptide drug products (i.e. those that vary in amino acid length and sequence, such as glatiramer acetate) the requirement is to demonstrate that the active ingredients in the generic are comparable to the Reference Product. To achieve this, BioPharmaSpec uses high-end analytical characterization and a comparability assessment using statistically significant data.

Structrural and Physicochemical Characterization

  1. Intact molecular weight analysis including an assessment for product-related impurities
  2. Primary amino acid sequence confirmation
  3. N-and C-terminal sequence analysis and confirmation of intactness
  4. Peptide mapping following proteolytic digestion (if required)
  5. Disulfide bridge analysis (for Cysteine containing peptides)
  6. Analysis of post translational modifications, if appropriate
  7. Amino acid analysis to provide amino acid molar ratios and peptide content
  8. Chromatographic analysis (RP-HPLC, IEX and SEC)
  9. IsoElectricFocusing (icIEF)
  10. Aggregation analysis (SEC-MALS and SV-AUC)
  11. Secondary and tertiary structure analysis (spectroscopic profiling; 1D and 2D NMR, Circular Dichroism (CD), Fourier Transform-Infra Red (FT-IR) and Fluorescence)
  12. Assessment of process-related impurities