Day One

• Which analytical technologies are generating the most excitement?
• What are the biggest characterization gaps today?
• Are we measuring the right CQAs?
• How will AI and automation transform analytical development?
• Which technologies will become standard over the next 5-10 years?

• Moving beyond particle size and reassessing CQAs for next-generation LNP therapeutics
• How should CQA strategies differ between discovery, IND-enabling, and commercial stages?
• How do we connect analytical attributes to potency, safety, and efficacy?

As the LNP Community unites, this session will provide valuable networking time with your peers,

enabling you to forge new and lasting connections and gain unfiltered insight to discuss your

challenges.

• Identify sources of variability during early formulation and process screening, reduce risk of downstream inconsistency
• Apply advanced characterization techniques to link particle attributes to encapsulation efficiency and performance
• Establish robust process understanding early, define critical parameters, improve reproducibility and scalability
• Integrate developability assessments into early workflows, prevent late-stage failures and rework

• If you could only release an LNP product with five assays, what would they be?
• What are the most over-measured attributes in LNP development today?
• Should every measured attribute eventually be linked to biological function?

• Applying SAXS and complementary techniques for LNP structural elucidation and conformational assessment
• Challenges in interpreting ensemble-averaged data in heterogeneous nanoparticle systems
• Progress toward developing standardized analytical frameworks for LNP characterization

• Combine advanced structural characterization with high-throughput workflows to generate deeper insight into LNP architecture, heterogeneity, and particle behavior earlier in development
• Translate structural data into actionable development decisions by linking particle attributes to formulation performance, manufacturability, and product quality
• Build scalable analytical strategies that balance detailed characterization with the speed and throughput needed to support modern LNP development

• Demonstrate that removing PEG-lipid from a four-component LNP system does not compromise colloidal stability, RNA integrity over nine months, or in vivo hepatic potency, provided surface charge is controlled through polyanion binding
• Microscale thermophoresis (MST) was originally developed for fluorescence-labelled protein binding and here adapted to directly quantify small-molecule ion binding to LNP surfaces, establishing anion–lipid affinity as a measurable parameter
• Deploy MALDI-MS imaging to spatially resolve ionizable lipid distribution across hepatic microanatomy at 20 μm resolution, linking formulation to intrahepatic biodistribution patterns

This is your opportunity to contribute to the conversation and share your cutting-edge research with this community while discovering exciting work carried out by your peers. To submit a poster, please contact info@hansonwade.com.

• Measure percent conjugated particles versus free particles, determine antibody or peptide density per LNP, assess conjugation uniformity
• Identify conjugation sites and ligand orientation, understand impact on targeting efficiency, optimize conjugation chemistry
• Develop potency assays that reflect binder function, correlate to in vivo targeting, predict clinical performance

• Apply high-resolution mass spectrometry to simultaneously characterize lipid, RNA, antibody, and conjugate components within targeted LNP systems
• Quantify conjugation efficiency, assess conjugation site specificity, and investigate product-related heterogeneity impacting therapeutic performance
• Establish comprehensive analytical workflows to support discovery, process development, and CMC readiness for targeted LNP therapeutics

• Reveal hidden LNP heterogeneity by combining bulk and single-particle analytics to better understand composition and structure function relationships
• Improve reproducibility and product control through advanced characterization of coupling efficiency, particle consistency, and key quality attributes
• Accelerate translation to CMC and QC readiness by integrating high-resolution