Biosimilarity – Abzena

Biosimilarity

A successful biosimilar development programme requires a comprehensive analytical assessment. Abzena offers through its biosimilar cell line development programmes an extensive repertoire of physiochemical and biophysical methods to identify the quality target product profile (QTPP) and define the product quality attributes to be used for selecting the best clones and for optimising bioreactor conditions. Extensive analytics and biological characterisation is applied to the lead biosimilar candidates to demonstrate biosimilarity.

Structural characterisation:

  • Intact and subunit mass
  • Peptide mapping including sequence coverage
  • Charge variant profiling
  • N-Glycan profiling (released and on glycopeptide level)
  • Site-specific modifications (deamidation, oxidation, glycation, pyroglutamate, lysine clipping)
  • Sialic acid analysis (quantification of Neu5Ac and Neu5Gc content)
  • Aggregation profile

Biophysical methods:

  • Determination of melting points (Tm)
  • 1H NMR fingerprinting

Example PQA analytics

Applied to a monoclonal antibody using N-glycan profiling and charge variant fingerprinting using CEX-UV

Working with Abzena

Abzena’s undertakes bioanalytical studies on behalf of clients as standalone projects or as part of larger development projects. We focus on developing the correct bioassay to help you understand your molecule and will help guide you in the correct choice of study.

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