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

  • Laurent Strodiot Director, Advanced Technologies R&D Drug Product, GlaxoSmithKline Plc

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

  • Ben Goffin MSAT mRNA Drug Product Expert, Pfizer

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 Innovations in LNP Drug Product Manufacturing: The Journey from Lab Formulation to GMP Production

Synopsis

  • Exploring Cutting-Edge LNP Formulation Techniques: Discover how our proprietary LNP manufacturing platform, the Nova BT IJM system, revolutionizes the art of lipid nanoparticle formulation with an optimal turbulent mixing approach.
  • Bridging the Gap-Learn how we excel at transitioning drug products from concepts to initial laboratory formulation to scalable GMP production, with a special focus on helping clients migrate from microfluidic processes.
  • Advantages and Implications: Gain insights into the advantages of our innovative approach and the cost-effectiveness it brings, especially for complex formulations and next generation LNP drug products.

11:15 am
Morning Refreshments & Poster Session

Driving Targeted Delivery to Extra-Hepatic Organs & Tissues

11:45 am Utilising Machine Learning Approach to Unlock Extra-Hepatic Delivery of Lipid Nanoparticles

  • Yogev Debbi Co-Founder & Chief Executive Officer, Mana Bio

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

12:15 pm Actively Targeting & Decorating your Lipid Nanoparticle for Efficient Delivery

  • Alexander Kros Professor - Supramolecular Chemistry, Leiden Unviversity Medical Center

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

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1:10 pm
Lunch & Networking

Analysing & Adapting Lipid Nanoparticles to the Breadth of Payloads Delivered

1:45 pm
Panel Discussion-Evaluating the Breadth of Payloads Currently Delivered in Lipid Nanoparticles to Establish Fundamental Differences in Development

  • Camilla Foged Professor - Vaccine Design & Delivery Group Leader, University of Copenhagen
  • Dimitrios Lamprou Professor / Chair of Biofabrication and Advanced Manufacturing, Queen's University Belfast
  • David Diaz-Oviedo Postdoctoral Research Scientist, Bayer Pharmaceuticals

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

2:30 pm Digital, Modeling and Automation in RNA/LNP Development

  • Selma Pereira Lopes Head of Drug Product Science, The Janssen Pharmaceutical Companies of Johnson & Johnson

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

3:00 pm Analysing the Next Generation of Nanoparticles & Throughout Lipid Nanoparticle Design to Evolve the Development Process

  • Camilla Foged Professor - Vaccine Design & Delivery Group Leader, University of Copenhagen

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

3:30 pm
Chair’s Closing Remarks

3:45 pm End of Conference