Biosimilar monoclonal antibodies: In vitro analytical testing and characterization of quality attributes and potency

March 27, 2013 8:42 AM

EUCRAF is organizing the “Biosimilar monoclonal antibodies: In vitro analytical testing and characterization of quality attributes and potency” event in Cologne, Germany on 24 May 2013.

EUCRAF, the European Centre For Regulatory Affairs, Freiburg has announced the agenda of its coaching event in Cologne and if you attend the event, you will be able to learn more information about following topics:

  • Quality parameters for characterization and testing required by regulatory guidelines
  • Typical spectrum of suitable tests for characterization of quality parameters
  • Selection and set-up of the potency assay for comparative testing
  • Practical considerations for the set-up of the comparative testing of the biosimilar and reference monoclonal antibody
  • Requirements for a biosimilar mAb stemming from a different expression system
  • Sample preparation and storage considerations
  • Defining similarity – data interpretation and handling of differing results

 

If you are interested, you can reach more information from here:

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