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Pharmaceuticals

Blood, Sweat, and Tears – Biologics and Their Challenges

Wednesday, May 8, 2024
15:40 - 16:40 CEST
Location: A 05 + A 06
Learning Level: Intermediate
Description: This session discusses a fundamental issue with biologics, namely the testing for unwanted immunogenicity. This is a look back over 30 years and a discussion where we stand now.

The second presentation illustrates the importance of natural resources for biologics, namely blood plasma. The regulatory landscape for traditional and for new products obtained from blood plasma is presented.

Learning Objectives:

  • Learn what assays will require what quality management systems from early stage drug development to post market
  • Understand the concept of addressing unwanted immunogenicity for biological therapeutics, with a focus on monoclonal antibodies
  • Understand the assay validation requirements for Anti-Drug-Antibody (ADA) tests and Neutralizing Antibody testing (NAb)