Technical / White Paper

Customized Biosimilarity Analytical Testing from Catalent

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Format: PDF file | Document type: Technical / White Paper

Customized Biosimilarity Analytical Testing from Catalent

Assessment of biosimilar molecules requires an orthogonal analytical approach.  Any one particular analytical technique is not able to fully define the physical and biological characteristics of the original biotherapeutic or its potential biosimilar.  Instead, a panel of analytical techniques must be used that can assess various and related, and sometimes overlapping, characteristics of the molecule.  This allows for a more complete and integrated understanding of the biotherapeutic molecule’s form and function.

Learn more about:

  • Orthogonal characteristics that need to be measured for a particular therapeutic molecule/target molecule interaction.
  • Using OCTET-analyzed binding kinetics as part of the orthogonal program and the assessment of biosimilar monoclonal antibodies (mAb).
  • Successful discrimination between different molecules/activities and how to ensure they are consistent with alternative (orthogonal) physicochemical analysis.

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