Biosimilar Characterization Considerations
Amino acid composition analysis
To provide a comparability assessment of the levels of each of the four amino acids in different batches/products.
N-terminal sequence analysis
To provide a comparative, quantitative assessment of the levels of the four amino acids across the first 15 N-terminal residues within the oligomers.
C-terminal sequence analysis
To provide a comparative quantitative assessment of the uncapped carboxyl C-termini.
To provide comparative peptide mass and fragment ion information using LC-MS (with MSe) in various forms and from various enzymatic digests.
Intact molecular weight distribution
To provide a comparative assessment of the molecular weight distribution of the various batches/products
To provide a comparative primary, secondary and tertiary structure analysis and also assess the comparative levels of capped and uncapped C-termini
Circular Dichroism (CD) and FT-IR analysis
To provide an orthogonal further assessment of secondary and tertiary structure
Mass and Charge Profile
- SEC-UV and SEC MALS