Highlights from the 17th Japan Bioanalysis Forum Symposium
The 17th Japan Bioanalysis Forum (JBF) Symposium was held on 4–6 March 2026 at the Himeji Culture and Convention Center (Arcrea HIMEJI, Hyogo, Japan). The theme, “Unlock Scientific Potential: Future of Bioanalytical Experts,” addressed the expanding diversity of modalities, technologies and regulatory expectations shaping modern bioanalysis. The program covered ICH M10 implementation, AI application in bioanalysis and laboratory automation, immunogenicity assessment, GLP data integrity (DI), patents in bioanalysis, oligonucleotide and gene therapy analytics, biomarkers, and biopharmaceuticals including antibody–drug conjugates (ADCs).
Record participation marked this year’s event, including a total of 457 attendees, 38 general/regular posters, and 12 discussion group posters—the highest numbers ever presented at a JBF symposium. Check out some of the highlights from this year’s JBF Symposium below.
New initiatives
Challenge for Junior Bioanalysts Session
The first-ever Challenge for Junior Bioanalysts Session showcased selected talks from five early-career bioanalysts. Presentations included LC–MS/MS quantification of endogenous biomarkers, multiplexed mAb quantification using engineering-enabled MS, development of a generic monkey ADA assay, evaluation of ultra-sensitive PK/biomarker assay platforms, and challenges in flow cytometry–based biomarker measurements. The initiative drew strong praise for supporting skill development and strengthening Japan’s next-generation bioanalytical workforce.
Casual Follow-Up Session (CFUS)
CFUS sessions (day 2 and day 3) allowed attendees to engage in direct, informal conversations with speakers. Participants valued the opportunity to immediately clarify questions, explore practical GLP DI and ICH M10 implementation issues, and dive deeper into analytical challenges. The CFUS was widely regarded as a highly impactful addition to the symposium.
Scientific highlights
Advances and Challenges in Bioanalysis of Oligonucleotide Therapeutics
Addressing the rapidly evolving field of oligonucleotide bioanalysis, this session focused on the development and validation of LC–MS and hybrid methods suitable for antisense oligonucleotides and siRNA therapeutics. As a representative example, a PAC-LC–MS/MS–based tissue bioanalysis method was presented, enabling adsorption-controlled extraction and simultaneous quantification of parent oligonucleotides and metabolites, with full validation aligned to ICH M10 principles.
Strategic activities of the European Bioanalysis Forum (EBF) towards the Future of Bioanalysis
The EBF session emphasized shifting bioanalytical thinking from compliance to consequence using context-of-use (COU), along with data-driven evaluation of singlicate versus duplicate analysis.
AI and Automation in Bioanalysis: Current Challenges and Future Directions
Examining advances in automated sample preparation and automation applied to LC–MS/MS method validation workflows, this session also explored the evolving global AI regulatory landscape (FDA, EMA, EU AI Act, Asia-Pacific) and associated legal and compliance considerations. Discussions emphasized how AI can enhance efficiency and data quality in regulated bioanalysis.
Advancing Immunogenicity Assessment: The Latest Topics in ADA/NAb Assays and the Reporting Standardization
ADA assay optimization for incretin therapeutics, neutralizing antibody strategies for ADCs, harmonization of ADA/NAb validation and reporting, and the emerging use of S/N ratios as a complementary readout to conventional ADA titers were addressed in this session. Flexible, fit-for-purpose immunogenicity strategies are increasingly important for complex and novel biologic modalities.
Shaping the Future of Biomarker Evaluation: Insights from Practice
The session addressed challenges in calibrator design, best practices for parallelism, tissue biomarker measurement strategies, and the use of KRAS G12D IHC assays for demonstrating pharmacodynamic effects.
Issues and Solutions for Data Integrity in GLP: Exploring Best Practices through Discussions with the Pharmaceuticals and Medical Devices Agency (PMDA), the Japan Society of Quality Assurance (JSQA), and Bioanalysis Facilities
Bringing together PMDA, JSQA, and industry stakeholders, OECD GLP DI guidance, audit trails, data governance, and transitions from paper to electronic records were discussed. The following CFUS enabled further practical dialogue on implementation challenges. Effective data integrity management requires both robust systems and a risk-based, organization-wide commitment.
Patents in Bioanalysis
This session covered the patentability of analytical methods, freedom-to-operate (FTO), licensing strategies, and approaches to converting scientific innovations into business opportunities. Awareness of intellectual property considerations is increasingly important for bioanalytical scientists developing novel methodologies.
Moving Forward with ICH M10 Implementation: Challenges and Solutions
Beginning with an overview of current implementation progress in Japan, the presentation summarized survey findings that revealed substantial variability in how Japanese pharmaceutical companies and CROs interpret and apply ICH M10 in practice. Following the presentation, a panel of experts from PMDA, the National Institute of Health Sciences (NIHS), pharmaceutical companies, and CROs discussed practical issues encountered during implementation. Successful ICH M10 implementation depends on harmonization balanced with scientific judgment and clear communication among stakeholders.
Latest Approaches to Quantification and Biodistribution Evaluation of Gene Therapy Products
This session highlighted digital PCR and qPCR for viral vector quantification, AAV formulation analytics, and biodistribution study considerations essential for regulatory submission. Advanced nucleic acid quantification technologies are central to reliable bioanalysis of gene therapy products.
Bioanalytical Strategy in Biopharmaceutical Development
An ADC-focused talk that discussed dual-payload ADC case studies and IA–LC/MS/MS quantification strategies, while another talk addressed best practices for selecting critical reagents essential for antibody drug assay robustness. Early strategic planning of reagents and analytical methods is key to managing the complexity of next-generation biopharmaceuticals.
Summary
The 17th JBF Symposium achieved significant advances in both scale and scientific depth. The launch of the Challenge for Junior Bioanalysts Session and CFUS fostered stronger community engagement and knowledge exchange. With broad discussions spanning AI, data integrity, oligonucleotides, gene therapy analytics, immunogenicity, biomarkers, and biopharmaceuticals including ADCs, the symposium provided a comprehensive and forward-looking perspective on the future of bioanalysis. As JBF continues to promote COU-driven scientific rigor and collaborative learning with the EBF, it is positioned to further influence the evolution of global bioanalytical science.
For more detailed information, please click the button below, which features some of the presentation materials:
CONFERENCE & PRESENTATION MATERIALS
The next JBF Symposium will be held in Omiya, Japan, in March 2027. The theme of the symposium will be “Advancing to the Next Stage,” reflecting our determination to move forward to the next phase amid the significant changes surrounding us. We hope that this symposium will serve as a platform for sharing discussions and learnings for collaboratively shaping the future of bioanalysis in Japan.
Disclaimer: the opinions expressed are solely those of the author and do not express the views or opinions of the Japan Bioanalysis Forum, Bioanalysis Zone or Taylor & Francis Group.
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