Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the
Philip Timmerman1, Matthew Barfield2, Kyra Cowan3
1European Bioanalysis Forum, 1000, Brussels, Belgium.
Insights
The European Bioanalysis Forum held four online workshops in 2021, covering immunogenicity, biomarkers, assay technology, and peptide/protein analysis. These sessions addressed scientific and regulatory challenges, emphasizing patient responsibility in bioanalysis.
Area of Science:
- Bioanalytical science
- Pharmaceutical research
- Regulatory science
Background:
- The SARS-CoV-2 pandemic necessitated virtual scientific exchange.
- The European Bioanalysis Forum adapted its meeting format to online workshops.
- Workshop themes were chosen to suit the virtual environment.
Purpose of the Study:
- To facilitate scientific discussion and knowledge sharing despite physical distancing.
- To address key challenges in modern bioanalytical science.
- To integrate scientific, regulatory, and patient-centric perspectives.
Main Methods:
- Organized four live interactive online workshops during the first half of 2021.
- Selected themes relevant to current bioanalytical practices and challenges.
- Facilitated discussions on immunogenicity, biomarkers, assay technology, and mass spectrometry applications.
Main Results:
- Successfully conducted workshops on critical bioanalytical topics.
- Highlighted challenges in immunogenicity testing and biomarker validation (Context of Use).
- Explored advancements in cell-based assays, ligand-binding assays, automation, and peptide/protein analysis using MS.
Conclusions:
- Online workshops can effectively address complex scientific and regulatory issues in bioanalysis.
- Continued focus on integrating Context of Use for biomarkers is essential.
- Technological advancements and robust analytical methods are crucial for peptide and protein analysis.
- Maintaining a patient-centric approach remains paramount in bioanalytical research and development.
Abstract:
During the first half of 2021, and due to the SARS-CoV-2 pandemic preventing in-person meetings, the European Bioanalysis Forum organized four workshops as live interactive online meetings. The themes discussed at the workshops were carefully selected to match the cyberspace dynamics of the meeting format. The first workshop was a training day on challenges related to immunogenicity. The second one focused on biomarkers and continued the important discussion on integrating the principles of Context of Use (CoU) in biomarker research. The third workshop was dedicated to technology, that is, cutting-edge development in cell-based and ligand-binding assays and automation strategies. The fourth was on progress and the continued scientific and regulatory challenges related to peptide and protein analysis with MS. In all four workshops, the European Bioanalysis Forum included a mixture of scientific and regulatory themes, while reminding the audience of important strategic aspects and our responsibility toward the patient.
