Conference Day Two
8:30 am Check-In & Breakfast
9:15 am Chair’s Opening Remarks
Bridging the Gap from Bench to Body: Advancing In Vitro & High-Throughput Screening Models to Accelerate Translational LNP Development
9:30 am Predictive in vitro Profiling of LNP-Induced Innate Immune Responses Using an iPSC-Derived Monocyte Model
Synopsis
- How can we accelerate translatable in vitro screening to efficiently identify promising LNP candidates?
- Maximising in vivo screening efficiency by testing multiple LNP candidates using minimal animal models
- What are the current limitations of in vitro models particularly in predicting the immune responses?
10:00 am Microfluidic Engineering of Milk Extracellular Vesicles for Oral Delivery of siRNA
Synopsis
- Engineering of milk extracellular vesicle (mEV)-lipid nanoparticle (LNP) hybrids using microfluidics for efficient siRNA oral delivery, overcoming RNA loading limitations of natural EVs
- Demonstration of improved safety, distinct uptake pathways, and enhanced delivery efficiency of hybrid particles compared to conventional mEVs and LNPs
- In vivo biodistribution showing promising colon-targeted accumulation after oral administration, highlighting potential for future clinical translation
10:30 am Session Details to be Revealed
11:00 am Morning Break & Networking
Ensuring Smooth Transition from Small Scale to GMP Through Advanced Mixing Technologies & Process Analytical Tools for Accelerated Consistent Manufacturing
11:30 am Selection Process & Steps to Scale LNP Formulation into the cGMP: Challenges & Mitigation From a Process Perspective
Synopsis
- How to select which LNP to scale: in vivo, in vitro data, LNP stability
- Characterization throughout the process development
- FDA interaction and stability of scaled LNP
12:00 pm Exploring Microfluidic Mixing & Alternate Methods to Ensure Equipment Versatility in the Route to GMP
Synopsis
- Are there any alternate methods or variations of current industrial scale methods for mixing which allow for automation?
- Unpacking how microfluidic or alternative mixing methods can fit into continuous flow processes to increase throughput and reduce batch-to-batch variability
- Innovations in real-time monitoring and control of mixing parameters to ensure product consistency
12:30 pm mRNA-LNP Development, Scale-up & Stability: Challenges & Opportunities
Synopsis
- Overview of mRNA-LNP specific quality attributes and mRNA-LNP development challenges
- Discussing the main scale-up, manufacturing process and thermostability challenges
- Understanding how to define a robust and holistic control strategy
1:00 pm Lunch Break & Networking
2:00 pm From Cold Chain to Shelf-Stable: Overcoming the Challenges of Spray Drying LNPs for Thermostable Therapeutics
Synopsis
- Presenting a next-generation inhalable RNA delivery platform based on spray-dried, room-temperature-stable LNP powders designed for efficient lung deposition upon pulmonary administration
- Detailing the formulation and process innovations that overcome key challenges such as RNA instability and inefficient delivery
- Highlighting therapeutic applications across chronic respiratory diseases such as severe asthma, COPD, and IPF
2:30 pm Overcoming the Challenges of Pulmonary RNA delivery: Spray-Dried LNPs as Thermostable & Inhalable Therapeutics
Synopsis
- Gain a deeper understanding of structural CQAs (Critical Quality Attributes) and the emerging analytical metrics, such as structural analogs to pKa, that enable more predictive and robust LNP characterization.
- Explore advanced analytical tools including light and neutron scattering, X-ray techniques, and novel assays for precise quantification of particle size, distribution, and internal structure.
- Learn how innovative quality control strategies go beyond routine HPLC-based checks to improve reproducibility and capture quality dimensions currently overlooked by standard methods.
Looking to the Future: Harnessing AI to Accelerate Patient Delivery
3:00 pm Using High Throughput Automation for Lipid Nanoparticle Design: Strategies to Optimise Composition, Function, & Therapeutic Performance
Synopsis
- Leveraging AI to decode structure-function relationships within LNP components, accelerating formulation decisions and reducing trial and-error in development
- Utilising predictive modelling to optimise lipid combinations for improved delivery, stability, and biodistribution, streamlining the path from concept to clinic
- Integrating experimental data with machine learning tools to design next-generation LNPs with greater precision, efficiency, and therapeutic reach