Bioanalysis Zone

Recent aspects and challenges in the assessment of immunogenicity

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The assessment of immunogenicity of biological protein drugs is a key component in drug development. A basic knowledge in immunology is a prerequisite for understanding the principles of adverse, unwanted immune responses. In addition, emerging technologies are making analytical and clinical data interpretation more challenging. Likewise, the comparative immunogenicity analysis of an innovative therapeutic and biosimilar needs to be addressed closely.

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What will you learn?

  • Basic immunology
  • Principles of immunogenicity testing
  • Challenges in cut-point determination
  • Immunogenicity of biosimilars

Who may this interest?

People interested in immunology:

  • Scientists
  • Analysts
  • CROs
  • Consultants
  • Quality Managers

Speakers

Arno Kromminga 80x95

Dr. Arno Kromminga
Senior Vice president, European Chief Scientific Officer
BioAgilytix/IPM Biotech

Dr. Kromminga is an esteemed senior expert for the assessment of immunogenicity of Biologicals. He and his team have developed and validated numerous assays in immunogenicity and drug monitoring for pre-clinical and clinical studies. One of his major interest is the interpretation of results to obtain clinically meaningful data. He studied Biochemistry and is a certified Clinical Immunologist. He is a co-founder and board member of the European Immunogenicity Platform (EIP), and member of multiple scientific societies including the American Association of Pharmaceutical Scientists (AAPS), German Society of Immunology (DGfI), and the German Society of Clinical Chemistry and Laboratory Medicine (DGKL). As a world-leading authority in the area of immunogenicity, he is invited to speak at numerous international scientific conferences and has authored multiple peer-reviewed scientific publications in journals and text books.

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