Biosimilarity | Abzena Biosimilar Manufacturers

Biosimilarity

A successful biosimilar development programme requires a comprehensive analytical assessment. Abzena offers through its biosimilar cell line development programmes an extensive repertoire of physicochemical and biophysical methods to identify the Quality Target Product Profile (QTPP) and define the product quality attributes which are used for selecting the best clones and for optimising bioreactor conditions. Extensive analytics and biological characterisation are applied to the lead biosimilar candidates to demonstrate their 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 formation and 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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