Highlights from the 16th Japan Bioanalysis Forum Symposium
Authors: Makoto Niwa (Nippon Shinyaku Co; Kyoto, Japan) and Naohito Yamada (Japan Tobacco Inc.; Yokohama, Japan)
The 16th Japan Bioanalysis Forum (JBF) Symposium (3–5 March 2025) took place as an on-site only event at Himeji Culture and Convention Center (Himeji City, Hyogo, Japan).
The theme of this year’s symposium was ‘Bioanalyst network: spread and circulation of knowledge’, emphasizing person-to-person communication among bioanalytical experts. The following report details some of the highlights from this year’s JBF Symposium.
Comprehensive approaches to immunogenicity assessment
With the increasing popularity of antibody drugs and the emergence of new modalities, there is a growing interest in immunogenicity evaluation. Efficient evaluation methods can replace the traditional three-stage evaluation of immunogenicity, informed by past experiences. Consequently, one session and one roundtable discussion were dedicated to anti-drug antibodies (ADAs). The focus was on rational, comprehensive and optimum approaches, with a view on recent advancements.
Key presentations included Joleen T White (Bill & Melinda Gates Medical Research Institute; MA, USA) providing an overview of a science-driven immunogenicity risk assessment. Paul D Chamberlain (Immunogenicity Integrated Platform) detailed the integrated summary of immunogenicity in the Common Technical Document. Kyra Cowan (Merck KGaA; Darmstadt, Germany)) provided an update on current discussions and recommendations from the EBF regarding ADA-related themes, including single-tier assays, drug tolerance and the use of biomarkers. Lauren Stevenson’s (Immunologix Laboratories; FL, USA) presentation centered around refining risk assessment to focus on the likelihood of clinically meaningful immunogenicity and implementing testing strategies for a more comprehensive view. Akiko Ishii-Watabe (National Institute of Health Sciences; MD, USA) presented on the draft guideline for immunogenicity assessment of biopharmaceuticals in Japan. Following the presentation session, a roundtable discussion was held to facilitate more in-depth interaction with participants.
Mass spectrometry-based innovative approaches for biomarkers and pharmacokinetics
The conference featured two significant sessions that highlighted advancements in mass spectrometry-based approaches. In one session, entitled “Quantitative proteomics and its application to biomarker research”, various presenters discussed cutting-edge approaches to clinical proteomics. Yoshiya Oda (The University of Tokyo; Japan) presented a technical assessment of proteomics through immuno-PCR and aptamer panels. Makoto Yamazaki (Mitsubishi Tanabe Pharma Corporation; Osaka, Japan) presented his research on biomarker discovery for amyotrophic lateral sclerosis (ALS) utilizing Olink Proteomics (Uppsala, Sweden) technology. Kuniyasu Kato (Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan) elaborated on his company’s proteomics platform, emphasizing the integration of large-scale data analysis and statistical methods to enhance the biomarker discovery process. Each presentation contributed to a comprehensive understanding of the ongoing efforts and innovations shaping the field of clinical proteomics.
The other session, “Progress in bioanalysis using new technology of mass spectrometry”, explored the latest technological advancements in mass spectrometry and their diverse applications. Hidenori Takahashi (Shimadzu Corporation; Kyoto, Japan) discussed structural analysis of oxygen and hydrogen radical-induced dissociation in mass spectrometry, highlighting the improvements in molecular characterization. Yuki Sugiura (Kyoto University; Japan) introduced ultra-high-sensitivity imaging mass spectrometry, which enables the visualization of bioactive molecules within biological tissues, offering significant insights into molecular biology based on the spatial distribution of biomolecules. Yoshiharu Hayashi (CMIC Pharma Science Co., Ltd.; Tokyo, Japan) illustrated the application of high-resolution mass spectrometry in the analysis of oligonucleotides, while Toshiko Yahata (Astellas Pharma Inc.; Tokyo, Japan) presented advancements in LC–MS/MS methods for the bioanalysis of antibody therapeutics, emphasizing the critical role of these techniques in pharmaceutical research.
Implementation of innovative approaches to new modalities
The afternoon of the final day was devoted to two sessions focusing on new modalities: cell and gene therapies (CGTs) and antibody-drug conjugates (ADCs).
The first session, entitled “Bioanalysis in cellular and gene therapies: standardization and implementation”, aimed to address the evolving landscape of drug development following the implementation of the ICH-S12 guideline. Daisuke Temmizu (Japan Pharmaceutical Manufacturers Association and Bristol-Myers Squibb; NY, USA) provided an overview of the ICH S12 guideline, emphasizing the importance of nonclinical biodistribution considerations for gene therapy products. Following this, Shunsuke Yamamoto (Takeda Pharmaceutical Company; Tokyo, Japan) discussed key considerations in the biodistribution assessment of cell therapy products. He highlighted the challenges currently faced in achieving reliable and standardized assessments, which are essential for clinical application and regulatory approval. The session concluded with a presentation by Satoshi Kitamura (Astellas Pharma Inc.), who explored the implementation and utilization of bioanalytical technologies in cell and gene therapy programs, from the standpoint of understanding biodistribution and kinetics.
The subsequent session, “Hot topics related to ADCs: new approaches and innovations”, focused on the analytical methods required for studying ADCs. Yuji Fujita (Astellas Pharma Inc.) presented a case study on measuring the blood concentration of ADCs, detailing the methodologies employed and the challenges encountered. Yuki Kishino (Daiichi Sankyo Co., Ltd.; Tokyo, Japan) followed with insights into the biotransformation processes of ADCs, emphasizing the analytical approaches necessary for a comprehensive understanding of the mode of action and biological fate of ADCs. Finally, Noritaka Hashii (the National Institute of Health Sciences) discussed the development of an analytical method utilizing LC–MS for determining the average drug-to-antibody ratio and drug loading distribution of ADCs in human plasma.
Summary
Overall, the 16th JBF conference addressed a variety of topics, including adaptation to reliability, optimization of analytical and validation strategies, implementation of novel technologies for new modality drugs, and interconnection of basic biology with analytical methodology.
The next JBF Symposium will be held at Himeji, Japan in March 2026. The theme of the symposium will be “Unlock scientific potential: the future of bioanalytical experts”, emphasizing the importance of scientific discretion in the daily operation of bioanalytical laboratories, and the role of bioanalysts.
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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