Characterization of Biologics and Biosimilars

Working with biologic drugs involves a huge analytical effort to understand the characteristics of the whole molecule in depth. Various methods and technologies are requires to get the analytical fingerprint of the molecule. An extensive analytical characterization based on an orthogonal approach is a key element for the project's success. We offer complex characterization projects for innovative biologics and comparison of biosimilars.

comparability.jpgOur experience covers a range of biologics such as:

  • Hormones
  • Toxins
  • Biosimilars (proteins and monoclonal antibodies)
  • Innovative proteins and innovative monoclonal antibodies
  • Antibody drug conjugates (ADC)
  • Therapeutic peptides: innovative, generic and hybrid formulations
  • Polysaccharides
  • Non-living vaccines 

 

Testing list:

  • General analytical techniques
  • Primary structure and post-translational modifications
  • Conformational analysis
  • Identity, content and protein related impurities
  • Process related impurities
  • Biological activity
  • Stability testing
  • Batch testing and batch release

 

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