Explore the Agenda
8:20 am Registration Opens & Morning Coffee
8:50 am Chair’s Opening Remarks
Pushing the Boundaries of LNP Formulations to Advance Extrahepatic Targeting for Improved Patient Outcomes
9:00 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
9:30 am Session Reserved for ReciBioPharm
10:00 am Panel Discussion: Overcoming Clinical Bottlenecks in LNP Development by Streamlining Processes for Advancing Safer Drug Products to Patients
- What are the greatest technical challenges in translating LNP formulations from preclinic to human studies?
- Given the complexity of LNP manufacturing, scale-up, and analytical characterization, what are the critical process and regulatory bottlenecks that currently slow clinical entry?
- How can developers prioritize indications, optimize clinical trial design, and build CMC readiness to ensure more programs successfully reach patients?
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
Chair – Peng Zhang, Principal Scientist, Science – Excipients, USP
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 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
1:00 pm Lunch & Networking Break
Analytical Development & Characterization
Formulation & Delivery
Process Development & Manufacturing
Analytical Development & Characterization
Optimizing LNP Characterization with High Throughput & Orthogonal Analytics for Consistent LNPs
2:00 pm Analytical Characterization of Nanoparticles in Vaccine Development
Associate Principal Scientist, Vaccine Analytical Research & Development, Merck & Co
- 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
NEW DATA
NEW COMPANY
2:30 pm Session Reserved for NanoFCM
2:45 pm Employing High Throughput, Semi-Automated Analytical Strategies to Accelerate LNP Formulation Optimization
Principal Scientist, 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
3:15 pm Afternoon Networking Break
Advancing Cutting Edge LNP Platforms for Precise & Safe Delivery of Immuno & Cell Therapies to Maximize Therapeutic Potential
4:00 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
4:30 pm Innorna: Engineering Targeted mRNA-LNPs to Advance In Vivo Immunotherapy
- From Protein Replacement to In Vivo Immunotherapy: Expanding the Reach of LNPs
- Translational Insights from Preclinical and clinical
- Enabling Extrahepatic Targeting and Non-IV Delivery Across LNP Designs
NEW DATA