Characterization of Biologics and Biosimilars

Working with biologic drugs represents a huge analytical effort to deeply understand the whole molecule characteristics. Different methods and technologies are needed to get the analytical fingerprint. An extensive analytical characterization based on an ortogonal approach is a key element for the project success.

comparability.jpgWe can afford complex characterization projects of innovative biologics or biosimilars comparison. Our experience covers a range of biologics such as:

  • Hormones and toxins
  • Biosimilars (proteins and monoclonal antibodies)
  • Innovative proteins or 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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