Immunogenicity - Challenge For Protein Drugs

This presentation discusses the shift in pharmaceuticals from small-molecule drugs to protein biologics and the associated challenges, particularly the immunogenic response. Explore research on the immunogenicity of high-risk biotherapeutics, explaining how anti-drug antibodies (ADA) can lead to safety and efficacy issues. Factors influencing immunogenicity risk are broken down into product-associated, disease biology-associated, and patient-associated. The concept of "humanness" in biotherapeutics and the role of T cell and B cell epitopes, biophysical properties, post-translational modifications, pharmacokinetics, and immune modulation are discussed. The presentation also covers techniques such as germlining to increase signal content and improve tolerance, with a study showing a significant reduction in ADA through germline mutations.