8:30 am
Morning Coffee & Networking
9:15 am
Chair’s Opening Remarks
Striving for Efficiency & Ease of Manufacture to GMP Scale
9:30 am From Lab to Large Scale Commercial Manufacturing: Developing Robust Processes from the Get Go
Synopsis
- Discussing the requirements to create a process with a view to growing at industrial scale
- Highlighting the stages of the process which need to evolve to reach industrial scale
- Understanding how the quality attributes of the LNP will change with scale up and how to protect this
10:00 am Scale-up of Nano-Drug Delivery Systems Manufacturing for Clinical Investigations
Synopsis
- Understanding scale-up requirements with case study to avoid common pitfalls
- Pre-define parameters with your process development teams to ensure seamless scaleup and scale-down considerations for robust validation
10:30 am Commercial At-Scale Manufacturing Techniques & Challenges Faced With LNPs
Synopsis
- Strategies on commercial LNP production to increase process robustness and supply reliability and flexibility
- Major watch outs and risks during commercial LNP production and potential remediations
11:00 am Session Reserved for HELIX BIOTECH
Synopsis
11:10 am
Morning Refreshments & Networking
Driving Targeted Delivery to Extra-Hepatic Organs & Tissues
11:40 am Utilising Machine Learning Approach to Unlock Extra-Hepatic Delivery of Lipid Nanoparticles
Synopsis
- Utilising lab generated data and available public data to design novel non-viral ex-liver cell-specific RNA delivery solutions
- Generating high throughput in vitro data to rapidly identify LNP drug delivery vehicles for given payloads
- Using Design-Build-Test-Learn cycles to accelerating drug development
12:10 pm Actively Targeting & Decorating your Lipid Nanoparticle for Efficient Delivery
Synopsis
- Rationalising the approaches to manipulate the lipid nanoparticle to precise locations
- Overcoming the challenges faced when trying to cross the blood brain barrier for neurological delivery
- Debating techniques used to alter the tructural composition of the lipid nanoaprticle, maintaining the integrity but improving the delivery
12:40 pm Session Reserved for ReciBio Pharm
Synopsis
1:10 pm
Lunch & Networking
Analysing & Adapting Lipid Nanoparticles to the Breadth of Payloads Delivered
2:10 pm Elucidating the Structure-Activity Relationship of RNA Lipid Nanoparticles
2:40 pm
Panel Discussion-Evaluating the Breadth of Payloads Currently Delivered in Lipid Nanoparticles to Establish Fundamental Differences in Development
Synopsis
- Reflecting on lessons learnt from recent approvals of lipid nanoparticle drug products
- Honing the differing approaches required when utilising different payloads to understand the interaction with the lipid nanoparticle
- Understanding the properties of a payload which have the greatest impact on lipid nanoparticle stability
3:10 pm Digital, Modeling and Automation in RNA/LNP Development
Synopsis
- The use of physical modeling in vaccine cold chain
- How CFD enables vaccine drug product development
- How we use Machine learning in RNA/ LNP development
3:40 pm Analysing the Next Generation of Nanoparticles & Throughout Lipid Nanoparticle Design to Evolve the Development Process
Synopsis
- Adopting a more synthetic approach, combining polymer and lipid to revolutionise the development of the nanoparticle
- Discussing the importance of PEG and potential alternatives in the next generation of lipid nanoparticles
- Utilising novel ionisable lipids when approaching lipid nanoparticle design