Publications by authors named "Brendy Van Butsel"
Article Synopsis
- Immunogenicity guidance in the biopharmaceutical industry has evolved significantly over the past 20 years due to initial negative reactions with erythropoietin, leading to stringent practices for all biotherapeutic drugs.
- A recent workshop by the European Bioanalysis Forum highlighted the need to reassess current immunogenicity testing methods, drawing from two decades of experience to suggest more relevant approaches.
- The proposed new paradigm encourages a context-based assessment of immunogenicity risk, viewing it as a pharmacodynamic biomarker, which aims to streamline testing strategies and better allocate resources for patient benefit.
