Topic 1:

Strategies to mitigate the impact of DAR Sensitivity by developing & qualifying appropriate Critical Reagents for DAR sensitivity and test different DAR standards to test for the potential impact of biotransformation; Understanding during method development the molecular entities being measured: single form, mixture, sub-domain of complex therapeutic modalities like ADC; Considerations of muti-domain warrants tailored PK & ADA assay strategies; Importance to use clinical samples to verify adequate insensitivity to different molecular forms.

Topic 2:

Overcoming issues with LBA Critical Reagents Stability stored long-term under frozen conditions, short-term at 2-8 Celsius to reduce potential degradation; Freeze-thaw cycles, continuous cold-chain preservation, degradation at temperatures above the glass transition represent continued challenges; Investigating Vitrification to stabilize Multiplexed Mixtures of Antibodies, Antibody-Conjugated Luminex microspheres, and Phycoerythrin-conjugated antibodies; Fully functional reagents stored at three temperatures up to 42 Celsius with the stabilizing sugar components in the vitrification buffer. 

Topic 3:

Emphasizing in-depth Characterization of Drug Targets (Protein Ligands) due to their unique properties, Stability Challenges, and potential impact on bioanalytical assay performance; Biophysical/biochemical analysis utilized to ensure Critical Reagent Quality & Assay Robustness; Critical early characterization of multiple ligand lots to ensure consistent production and assay reliability; Influence of dimers, oligomers, sizes and post-translational modifications of ligands on assay signals and binding affinity; Issues with drug targets obtained from commercial sources.

Topic 4:

Growing Bioanalytical Complexities in supporting the development of Advanced Therapeutic Modalities; Needs for Innovative Problem-solving Approaches in ADA Assay Development to support advanced therapeutic modalities; Comparing S/N versus Titer data to inform the ADA data interpretation; Detailed the mechanistic investigation of unexpected findings during ADA Assay development of multivalent bispecific antibody; Strategic integration of Novel/Emerging Technologies in order to deepen understanding of novel drug.

Topic 5:

Challenges in developing/validating Multi-tier ADA Assays for Complex Modalities: assay design & increased bioanalytical burden; Retrospective assessment of Assay Performance using data from single-well validated five-tier ADA Assay for alignment with duplicate-well results; Evaluation of reproducibility/robustness during method development to optimize validation; Comprehensive statistical comparison of single/ duplicate-well results across multiple tiers, evaluating precision, sensitivity, CP; Data-driven evidence supporting strategies to streamline ADA assay validation while maintaining scientific rigor & regulatory compliance.

Topic 6:

Present ADA Assays and immunogenicity testing strategy implemented to support the demonstration of comparability for Biosimilars; Evaluation of clinical immunogenicity results and issue affecting the robustness of data; Outcomes of troubleshooting experiments and adaptation of immunogenicity testing strategy; Clinical evaluation of the impact of immunogenicity on the Pharmacokinetic, Pharmacodynamic and Efficacy Data and over all lessons learned; Updated immunogenicity results obtained with adapted testing strategy for clinical trials.

Topic 7:

Cutting-edge strategies for a streamlined Development & Validation of Screening, Confirmatory, Titer, Domain Specificity, Cross-reactivity Assays for Fc Fusion Protein with Endogenous Counterparts in support of Clinical Trials; Specific use of acid dissociation/bead extraction for NAb assay and Cross-reactivity NAb assays; Focus on high sensitivity, appropriate Cut Points (CP), strong drug tolerance, target interference; Correlation analyses between ADA, PK, PD, efficacy, safety data to assess Clinical Relevance.

Topic 8:

Revisiting NULISA Platform Performance after one more year of experience; Advanced assay principles, unique features, applications in Biomarker/IVD/CDx; Comparative analysis of NULISA versus high-sensitivity SIMOA and Fujirebio Lumipulse; Differences in detection limits, dynamic range, and sensitivity across selected biomarkers; In-depth assessment of assay robustness, parallelism, reproducibility, streamlined workflows, reduced complexity, and enhanced scalability for high-throughput applications; Discussion of benchmarking findings, implications to drive advancements in Translational Science & Diagnostics.

Topic 9:

Current Multiplex LBA enabling simultaneous measurement of diverse analytes from minimal sample volumes, increasing efficiency, reducing cost, and maximizing data from exploratory/translational studies; Issue with earlier platforms: Luminex, Ella, SPX; Next-generation high-sensitivity platforms, Olink & NULISA, providing enhanced dynamic range, robust multiplexing capability, and improved tolerance to complex, disease-relevant biological matrices; Evaluation of these technologies on how multiplex technologies can accelerates biomarker-driven decision-making, and drives the strategies in drug development.

Topic 10:

Latest Emerging Technologies (ET) for LBA to overcome Method Development challenges; Why looking for new interesting ET? Solving challenging clinical questions and fulfilling bioanalytical gaps; What to look for and how to test ET? What operational parameters makes ET attractive? Consideration on High/Ultra Sensitivity, high speed, fully automated, low complexity, reproducibility high throughput, multiplexing, CRO Availability; What are the key preanalytical considerations for ET? Evaluating sample handling, sample volume and sample stability?  

Topic 11:

Advanced Strategies for development of PD Biomarker LBA despite structural similarities focusing on Temperature Sensitivity and Sample Handling; Considerations on minimizing Concomitant Medications Interferences based on method redesign using anti-ID antibodies; Assay Performance with different LNP components and use of AI-based Optimization of buffer combination acid dissociation; Reinforcing that even small changes in sample handling or assay conditions can significantly impact antibody-based methods, underscoring the need for tailored approaches when mitigating protein interference.

Topic 12:

Recent developments on the Assays used for Quantification of plasma PEG Concentrations and anti-PEG Abs; Safety monitoring of pegylated therapeutics by monitoring PK profile, PEG concentrations, ADA and anti-PEG Abs; Safety impact evaluation of pegylated concomitant medication or PEG-containing vaccinations; Importance of Pegylation technology to improve therapeutic compound's stability, solubility, delivery, biodistribution, extended drug half life, reduced immunogenicity as compared to similar products.

Topic 13:

Thorough Comparison of CBA with Competitive LBA for Neutralizing Antibody assay formats; Parallel development & evaluation to allow for a data-driven decision aligned with MoA and clinical needs; Regulatory Guidance for CBA as preferred approach for neutralizing antibody characterization assessments vs competitive LBA; Validation of competitive LBA and use to support global clinical trials showing to be more robust and clinically relevant expected drug tolerance.

Topic 14:

Severe issues with Target Interference causing a false positive or negative signal; How can soluble target be removed without the need of specific reagents? How can non-covalent bound Dimer Target Interference be mitigated? How can Multimeric Target Interference false positive signal be reduced while keeping the assay sensitivity? How to deal with Unknown Matrix Interference causing high assay variability? Should high variability for a robust CP be kept or should interference be reduced? Can confirmatory assay guide during assay development? 

Topic 15:

Highlighting strategy, challenges, solutions to investigate Total Target Interferences; Risks in overlooking total target interference and need for ADA/NAb Assay redevelopment to deplete total target, using predicted drug concentrations as tolerance limits; Novel Validation Design for drug and target interferences based on Fit-for-purpose (FFP) approach to address clinical concerns; Lesson Learned from ADA/NAb assays evolving alongside emerging clinical study designs based on key early clinical data. 

2026 White Paper on Ligand-Binding Assays

Consensus & Conclusions on Ligand-Binding Assays for 2026 White Paper