Explore the Agenda
7:50 am Registration Opens & Morning Coffee
8:20 am Chair’s Opening Remarks
Pushing the Boundaries of LNP Formulations to Advance Extrahepatic Targeting for Improved Patient Outcomes
8:30 am Targeted Delivery of Therapeutic Cargo to T Cells & HSC with Extrahepatic Tropism
- Antibody-Free Targeted Delivery via LNP Engineering: Our investigation into targeted delivery to T cells and hematopoietic stem cells (HSCs) using lipid nanoparticle (LNP) formulation modifications, supported by both in vitro and in vivo data, demonstrates the potential of antibody-free strategies for cell-specific mRNA delivery
- Ligand- and Antibody-Mediated Targeting Approaches: We also explored targeted delivery to T cells and HSCs using antibody or ligand conjugation methods, comparing their efficiency and specificity to non-antibody-based approaches
- Key Observations and Insights: We will share critical findings from both delivery strategies, including comparative performance, biodistribution, and implications for therapeutic applications
9:00 am Integrating Mast Cell Bioassays into Safety & Immunogenicity Assessment of LNP-Based Therapeutics
- Demonstrating how mast cell bioassays can identify PEG-related and other allergic reactions caused by mRNA/LNP vaccines and LNP-enabled therapeutics
- Correlating specific LNP attributes, excipient profiles, and manufacturing variables with mast cell activation signatures that predict allergic reactions observed in clinical settings
- Establishing a practical framework for integrating mast cell bioassays into LNP formulation and process development workflows to enhance safety assessment, mitigate scale-up risks, and meet regulatory expectations for emerging LNP modalities
9:30 am Flatsheet Process Development: Loading, Cross Flow & Transmembrane Pressure (TMP)
- Investigating the capacity of flatsheet cassettes using different materials of construct
- Establishing head-to-head comparison with hollow fibers
- Pushing the boundaries of TMP, cross flow and loading
10:00 am Panel Discussion: Overcoming Clinical Bottlenecks in LNP Development by Streamlining Processes for Advancing Safer Drug Products to Patients
- What are the most crucial technical challenges in translating LNP formulations from preclinic to human studies?
- As the field moves from early clinical programs to commercialization, what are the key challenges in translating LNP formulations from small-scale development into robust, large-scale manufacturing processes?
- How to optimize the dosing strategies for LNPs to ensure safe and effective therapeutics?
10:30 am Morning Networking Break
Don’t forget to enjoy some refreshments before we split off into 3 different tracks: Analytical Development & Characterization, Formulation & Delivery and Process Development & Manufacturing.
Analytical Development & Characterization
Formulation & Delivery
Process Development & Manufacturing
Analytical Development & Characterization
Harnessing Analytics to Assess Excipients, Raw Materials & Solvents for High Quality LNP Products
11:30 am USP’s Evolving Approaches on Excipient Standards & Solutions Offerings in LNP Drug Development
Senior Scientist II, USP
- Gain insights into iterative approaches on excipients standards and solutions to address stakeholders’ needs
- Learn about the value of the standards and solutions of raw materials quality and testing
- USP’s stakeholder engagement model
12:00 pm Characterizing Lipid Nanoparticles with ZetaView® NTA: High-Resolution Size, Concentration, and Stability Analysis for Advanced Formulation Development
Sales & Product Manager, Particle Metrix
- Simultaneous determination of particle size distribution and absolute particle concentration in a single NTA measurement for comprehensive LNP characterization
- Fluorescence-enabled subpopulation analysis to resolve labeled fractions within complex or heterogeneous nanoparticle formulations
- Integrated zeta potential measurement for quantitative assessment of colloidal stability and surface charge properties
12:10 pm Roundtable Discussion: Designing Quality Control Strategies to Ensure Raw Material Purity to Minimize LNP Instability
Associate Principal Scientist, Vaccine Analytical Research & Development, Merck & Co
- How to effectively evaluate and verify raw material purity beyond vendor specifications?
- What quality control measures are essential for enzymes and excipients to ensure consistency and prevent LNP instability?
- How to develop effective screening strategies for raw materials that correlate impurity profiles with LNP stability and product performance?
Formulation & Delivery
Process Development & Manufacturing
12:30 pm Lunch & Networking Break
Analytical Development & Characterization
Formulation & Delivery
Process Development & Manufacturing
Analytical Development & Characterization
Leveraging High Throughput & Orthogonal Analytical Strategies for Robust LNP Characterization to Optimize Formulations
1:30 pm Analytical Characterization of Nanoparticles in Vaccine Development
- Understanding how particle size, charge and molecular weight influence biodistribution, stability, and immunogenicity
- Leveraging SEC for the assessment of LNP homogeneity, aggregate detection, and encapsulation efficiency
- Applying DLS to characterize size distribution and polydispersity, and to monitor batch-to-batch consistency
2:00 pm Single LNP Characterization for Formulation & Process Development: Understanding Empty particles, Payload Distribution & Targeting Molecule Display
Field Application Scientist, Nano FCM
- Learn how nanoflow cytometry techniques reveal the details of your LNP formulations including size, concentration (particles/ml) payload distribution, in terms of both loaded and empty particles, and quantification of the payload per particle
- Understand the display of surface markers on each LNP to determine how and how active the targeting molecules attached to your LNP are
- With low sample requirements, quick easy assays, and simple data collection tools from NanoFCM are allowing formulation and process development groups to gather data that provides granular, detailed data regarding the state of the sample
2:10 pm Employing High Throughput, Semi-Automated Analytical Strategies to Accelerate LNP Formulation Optimization
Principal Scientist, Biochemistry & Biophysics, Analytical Development, Sanofi
- The implementation of high throughput lipid content analysis to evaluate new LNP formulations
- The use of automation to streamline sample preparation and increase testing capacity without compromising data quality
- The use of 3D printing technology to accelerate automation development timelines
NEW DATA
Formulation & Delivery
Process Development & Manufacturing
2:40 pm Afternoon Networking Break
Advancing Cutting Edge LNP Platforms for Precise & Safe Delivery of Immuno & Cell Therapies to Maximize Therapeutic Potential
3:15 pm DCITE: The Inside-Out Approach to Immune Modulation
- Uncovering the delivery of cGAS-STING pathway activators via mRNA
- Effecting T-cell phenotype through dendritic cells via LNPs
- Showcasing the clinical application of DCITE for effective immunotherapies
NEW COMPANY
3:45 pm Engineering Targeted mRNA‑LNPs to Enable In Vivo Immunotherapy for Autoimmune Diseases
- NHP data demonstrating the potential of targeted mRNA‑LNPs to enable in vivo immunotherapy for autoimmune disease models
- Robust B‑cell depletion across peripheral blood, spleen, and lymphoid tissues using a proprietary targeted LNP delivery platform
- Evidence of immune‑reset biology with emerging safety and tolerability supporting continued preclinical development
NEW DATA