Biosimilar Analytical Services / GMP

Comprehensive analytical comparability and characterization services for biosimilar development and regulatory approval.

The development of a biosimilar requires a significantly more extensive analytical programme than that of a conventional generic drug. Demonstrating biosimilarity to the reference product requires a comprehensive analytical comparability exercise covering a broad range of physicochemical, structural, and functional quality attributes using multiple orthogonal analytical techniques. This analytical dataset forms the cornerstone of the biosimilar regulatory dossier.

The EMA, FDA, and ICH have established detailed guidance defining the analytical requirements for biosimilar development, emphasising a stepwise totality-of-the-evidence approach, in which a robust analytical comparability package may reduce or, where scientifically justified, eliminate the need for certain clinical studies.

AMSbiopharma provides integrated biosimilar characterization and analytical comparability services, delivering the analytical expertise and validated methodologies required to generate robust, regulatory-grade comparability data in support of biosimilar development and regulatory submissions.

Our catalog of services include

Biosimilar Characterization and Analytical Comparability (Identity, Content, Protein and Impurities)

Demonstrating biosimilarity requires a comprehensive analytical comparability programme that systematically compares the proposed biosimilar with the reference product across all relevant quality attributes, using the most sensitive and discriminatory analytical methods available. The comparability exercise should encompass primary structure, higher-order structure (HOS), post-translational modifications (PTMs), physicochemical properties, purity, impurity profiles, aggregation state, charge heterogeneity, and functional activity.

AMSbiopharma provides integrated characterization and analytical comparability services covering all critical quality attributes required for biosimilar development. Identity is confirmed by primary structure analysis and LC-MS/MS peptide mapping. Protein content is determined using validated quantitative methods. Purity and impurity profiles are characterised using HPLC, capillary electrophoresis (CE), and mass spectrometry techniques. Glycosylation is profiled through released glycan analysis, while charge and size heterogeneity are assessed using ion-exchange chromatography (IEX), isoelectric focusing (IEF), and size-exclusion chromatography (SEC).

Key analytical capabilities

  • Primary structure confirmation and sequence integrity assessment by LC-MS/MS peptide mapping 
  • Protein content determination using validated quantitative methods 
  • Purity and aggregation profiling using multiple orthogonal analytical techniques 
  • Glycosylation characterization by released glycan profiling and glycopeptide mapping 
  • Functional activity and binding characterization to support analytical comparability