Publications by authors named "Foka Venema"
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.
The European Bioanalysis Forum, in collaboration with several key industry stakeholders, has recently led discussions that address international immunogenicity guidance documents, specifically the three tier approach for immunogenicity testing strategies, after more than 20 years of experience with biotherapeutics. As part of this, the strategy and methods used to assess drug tolerance across all immunogenicity assays are challenged, emphasizing that bioanalytical scientists need to consider the context-of-use of each assay. Here, recommendations for drug tolerance assessments, driven by strong scientific rationale and subject to reevaluation as needed, are provided.
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