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

  • Emily Port Team Leader & Principal Scientist, Nanopharmaceuticals, CPI

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

  • 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 Session Reserved for HELIX BIOTECH

Synopsis

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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

  • 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

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

  • 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

3:40 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

4:10 pm
Chair’s Closing Remarks

4:25 pm End of Conference