7:30 am
Registration & Welcome Coffee
8:45 am
Chair’s Opening Remarks
8:55 am
Establishing Thorough Analytics & Characterisation of the Lipid Nanoparticle to Ensure Accurate CQA Assessment
9:00 am Exploring Analytical Approaches to Quantify Particle Size & Distribution Index
Synopsis
- Understanding the metrics required to holistically profile the lipid nanoparticle
- Overviewing the tools and technologies available to adequately quantify the structural properties of the lipid nanoparticle
- Debating the CQAs and their importance to keep consistent for long-term structural stability
9:30 am Continuous Inline Size Monitoring of LNP in Manufacturing using Spatially-Resolved DLS
Synopsis
- Exploring the necessities of PAT in LNP development
- Implementing SR-DLS for monitoring and controlling the particle size distribution of LNP during manufacturing
- Applying the SR-DLS technique for PAT solutions of LNP development
9:45 am Learning from nature: are milk EVs the perfect model for lipid nanoparticles for oral delivery of nucleic acids?
Synopsis
- Challenges of current LNPs for oral delivery
- Advantages of milk EVs
- Loading and transportation with EVs
- EV mediated delivery of siRNA
10:15 am Detecting impurities in your lipid nanoparticle (LNP) biopharmaceuticals
Synopsis
- Discover how LC-MS/MS is being used to understand the structure of mRNA
- Find out how LC-MS/MS is now being used to identify lipid impurities which can affect drug activity
- Understand how CE can speed up the size impurity profiling of mRNA
10:45 am
Morning Refreshments & Speed Networking
Developing a Detailed Safety Profile to Mitigate the Probability of Risk
12:00 pm Potential Concerns with Repeat Doses of Lipid Nanoparticle Drug Products for Chronic Lung Diseases
Synopsis
- Spotlighting the role lipid nanoparticles can play in the treatment of chronic diseases
- Addressing the industry concerns when administering lipid nanoparticles to limit accumulation
- Quantifying the fluctuations in endosomal release efficiency throughout time
12:30 pm Outlining Oligo Drug Delivery & LNP Platform
Synopsis
- Understanding that LNP for oligo drug delivery comes from efficient process technologies
- Using innovative APIs for better therapeutic index
- Efficient scale-up of LNP and complex payloads with GMP in mind
1:30 pm
Lunch & Networking
Optimising Formulation to Ensure Stability & Purity Through Consistent Process Development
2:30 pm Compliant Scalability of LNP Manufacturing – From Lab to 1 Billion Dose
Synopsis
- Advancing your process engineering to scale-up and not scale out
- Deploying PAT to ensure product quality
2:45 pm
Panel Discussion – Identifying the Array of Tools Available for Formulation to Design the Most Optimal Lipid Nanoparticle
Synopsis
- Sharing lessons learnt across the last year when innovating methods of formulation
- Exploring the array of tools and technologies being used to optimise formulation
- Forecasting the future scope of lipid nanoparticle formulations
3:30 pm Automated High-Throughput Screening of LNP Formulations
Synopsis
- Outlining current challenges and proposed solutions
- Delving into the benefits of microfluidic technologies
- Employing automated mRNA-LNP formulation screening
3:45 pm
Afternoon Refreshments & Poster Session
4:15 pm Microfluidics vs Traditional Formulation Methods For Sustainable & Scalable Manufacturing: Past, Present & Future
Synopsis
- Lipid-based (e.g., liposomes, solid lipid nanoparticles, niosomes, exosomes) nanoparticles formulation requirements
- Comparing traditional formulation methods, e.g. extrusion, high pressure homogenisation, thin film hydration with the next generation microfluidics for sustainable LNP formulation
- Scale-up and scale-out approaches to increase efficiency and reduce COGS
4:45 pm Scale-Up Strategies and Manufacturing Workflows for Commercial Production of RNA-LNPs
Synopsis
- Manufacturing considerations and adaptations to ensure scalability, workflow efficiency, and compliance from early-stage development to commercial production
- How to increase operational flexibility to address novel molecules and expand LNP delivery strategies to new applications beyond mRNA vaccine development
- Strategies to enable high throughput demands required for large-scale manufacturing of RNA-LNP drug products for different therapeutic applications and stages of clinical development
5:15 pm Implementing Robotics & Automation to Screen Lipid Nanoparticles for Optimal Formulation
Synopsis
- Adapting encapsulation and downstream clean up steps for a low volume, high throughput automated system
- Implementing a characterisation workflow to help downselect formulations
- Harnessing advanced digitalisation tools to assist with formulation development and structure-function understanding