Pre-Conference Workshop Day
Tuesday, 17 October
Workshop A – LNP 101: Deep Dive into the Structural Properties of Lipid Nanoparticles
- Federica Sebastiani Assistant Professor, University of Copenhagen
With LNP being a novel non-viral delivery vehicle, there is an increased focus of its application for next generation nucleic acid based medicines and the urge of answering extrahepatic delivery possibility. Scientists now need to quickly learn the nanoparticle's biophysical and biochemical propertise, which can impact on the interaction of LNP-payload biodistribution and process development requirements. This hands-on interactive workshop will aim to give you the in's and out's of how to leverage LNP screening, understand LNP's biology and in conjunction latest technologies to empower your end-to-end drug development.
Built to include discussions with your fellow peers, this session will provide you with the answers to:
- Advancing your understanding of the structural properties of the lipid nanoparticle
- Exploring the interactions between components of the particle
- Identifying the contributing factors to overcome instability in lipid nanoparticle development
Morning Refreshments & Speed Networking
Workshop B – GMP Commercial Production of Lipid Nanoparticles: Scale up or Scale Out?
- Mostafa Nakach Global Head Of Process Engineering and For Biologic Drug Product Development, Sanofi
Mostafa Nakach is one of the few industry seasoned experts in LNP field who has seen through LNP and novel biologics scale-up. As your LNP pipeline progresses, the ability to ensure a seamless tech transfer, scale-up efficiency will be critical to support IND filing and commercialisation. Through interactive discussion and a practical case study, you will learn how Mostafa led his Sanofi team to approach GMP manufacturing of LNP and drug product, and equip you with the right parameters whether you are scaling up with your internal capabilities, or looking for outsourced partners.
In this interactive session, you will have the unique opportunity to seek his firsthand advice in:
- Debating the benefits of LNP scaling out and manufacturing in parallel
- Proposing the long-term approach of scaling up and whether scaling outoffers a solution
- Ensuring the consistency of lipid nanoparticle production across parallel systems
- Revealing case studies of the strengths and limitations of the scale up or scale out approach
Lunch & Networking
Workshop C – Evaluating the Promise and Challenges of LNP Efficacy and Safety Testing In Vitro
- Alexander Kapustin Associate Principal Scientist, AstraZeneca
Huge emphasis is placed on the safety profiles of lipid nanoparticles to mitigate any risk of adverse effects for the patients. Significant promise has been placed on LNPs to become the safest delivery vehicle for drug products leading to significant research into how industry can adequately profile the safety of the LNP drug product.
Join AstraZeneca to hear their insights whilst gaining a unique opportunity to discuss and ask your questions on a variety of safety-focused topic areas including:
- Exploring the role of inflammation in RNA therapeutics
- Brainstorming what is known about lipid nanoparticle-induced inflammation?
- Debating where are are now with the LNP efficacy & safety testing in vitr