Conference Day One
Wednesday 13th September 2023
8:00 am Welcome Coffee & Registration
9:15 am Chair’s Opening Remarks
9:20 am Overcoming Heterogeneity of LNP Structure & Morphology to Establish a Greater Understanding of Encapsulation Efficiency
9:30 am Examining the Morphology of the LNP to Advance Understanding of the Functional Impact
Synopsis
• In-depth Characterization of LNP to Enhance Product Understanding
• Ensuring detailed understanding of the molecular structure of LNP surface
• Higher resolution analysis of size distribution of LNP
• Seeing is believing with image analysis for LNP size and morphology
10:00 am Techniques to Overcome Heterogeneity Challenges for a Deeper Understanding of LNP Properties
Synopsis
- Recognizing major sources of heterogeneity and consistency throughout the LNP formulation process
- Impact of heterogeneity of LNP efficacy and potency and the pivotal role of QC and QA
- Developing tools to standardize characterization and analytical methods with increased variability across LNPs constituents
10:30 am Linking LNP Physicochemical and Biological Properties to Better Understand their Safety
Synopsis
- Structure-activity relationships between LNP components and biological responses (inflammation, toxicity, biodistribution, clearance)
- PEG and PEG alternatives
- In vitro and in vivo models for safety studies of LNPs
- In silico models, computer-based and AI-algorithms to predict LNP safety profiles
11:00 am Morning Refreshments, Speed Networking and Tech Slam
11:30 am Aligning the Industry approach of Quality Control Metrics to Translate Data Efficiently to Maximize Integrity & Purity of the LNP Complex
12:00 pm Roundtable discussion – Tackling Impurity Thresholds to Review the Required Target with an Appreciation of Degradation Impact
Synopsis
- Reviewing what ‘good’ looks like when striving for purity
- Correlating impurity metrics with risk of degradation
- Discussing realistic purity metrics to maximise control as well time efficiency
12:45 pm Assessment of LNP Qualities & RNA loading by Nano-flow Cytometry
Synopsis
- Quantify particle concentrations and size distribution >40nm label-free
- Simultaneously identify encapsulated or surface-presented material in loaded subpopulations using fluorescence
- Multi-parameter measurement of a range of nanoparticles with flexible labelling of targetable material
1:00 pm Analysing the Lipid Composition Following LNP Formulation to Increase Nanoparticle Purification
Synopsis
- Benchmarking success when characterizing the lipid composition to maximize purity following LNP formulation
- Understanding the purity outcomes with multiple lipids and conjugates as well as a payload through accurate characterization
- Distinguishing lipid compartments and ratios with an appreciation of impurity production
1:30 pm Lunch & Networking
2:00 pm Optimizing Payload Characterization to Better Predict LNP Complex Outcome
2:30 pm Evaluating the Technology Available to Execute Thorough Characterization of LNPs
Synopsis
- Exploring the future of LNP characterization and analytical development with emerging technologies holding promise
- Debating the strengths and weaknesses of the current analytical tools available to market
- Contrasting the technologies used in academic research in comparison to industry
3:00 pm Probing Structure and Conformation of mRNA-Lipid Nanoparticles
Synopsis
- Reviewing the characterization tools in use to profile the mRNA drug substance
- Understanding the conformational changes of the LNP that occur following the encapsulation of the mRNA
- Debating how the function of the LNP complex can be relayed back to the initial characterization of the LNP and mRNA