Day Two: Thursday, 20th October 2022

7:30 am Morning Coffee & Registration

8:20 am Chair’s Opening Remarks

  • Shahid Uddin Senior Director of Formulation & Stability , Mendus

Honing Formulation Methods for Improved Stability

8:30 am Advancing Methods to Address the Stability Challenge

  • Sune Andersen Principal Scientist in Particle Engineering , Janssen

Synopsis

  • Understanding that LNPs are not stable at room temperature
  • Exploring freeze-drying as a formulation method – finding an equilibrium between the particle and the medium
  • How to navigate shelf-life instability to improve formulation

9:00 am Roundtable Discussion: LNP Stability & Storage – Overcoming the Barriers

Synopsis

  • Understand and explore new delivery modalities
  • Identifying routes of administration and biological barriers
  • What are the storage and stability barriers with LNPs?

9:30 am Session Reserved for NanoFCM

Capitalising on LNP Product Quality & Regulatory Guidance

9:45 am Fireside Chat: Accelerating LNP Products into the Clinic – Beyond Vaccines

Synopsis

  • Shaping the development in the regulatory aspects
  • Where can academia and industry come together in the context of disease indications?
  • An update on toxicity and early safety assessment and expectations
  • What are the unmet medical needs that can be served by LNPs?

10:15am | Networking & Morning Coffee

11:00 am Session Reserved for Polypeptide Therapeutic Solutions

LNP Process Development & Manufacturing to Drive Efficient Scalability

11:30 am Outlining Oligo Drug Delivery & LNP Platform at WuXi STA

  • Lu Tian Director, CMC Project Management, STA Pharmaceutical

Synopsis

  • Understanding that LNP for oligo drug delivery comes from efficient process technologies
  • Using innovative active excipients for better therapeutic index
  • Exploring STA’s end-to-end enabling service to help develop oligo therapeutics for patients

12:00 pm Accelerating Scale Up & GMP Manufacturing of LNPs

Synopsis

  • Exploring process parameters and developing a flexible platform manufacturing process
  • Outlining the GMP manufacturing capabilities
  • Highlighting the UK capability centre to support companies working with LNP-enabled therapies

12:30 pm Session Reserved for Knauer

12:45pm | Networking Lunch

1:45 pm Panel Discussion: Review the Challenges of Effectively Scaling LNPs

Synopsis

  • Understanding your volume requirements depending on your disease indication
  • Obtaining the resources – how can companies get the resources they need to test the scale up and manufacturing beyond lab scale?

2:15 pm Scale Up of Nano-Drug Delivery Systems Manufacturing for Clinical Investigations

Synopsis

  • Outlining the scale down / scale up considerations
  • Delving into scaling up requirements
  • A case study: scaling up of liposomes manufacturing process

2:45pm | Afternoon Break

3:15 pm Optimisation of Continuous Manufacturing for Liposomal Drug Products

  • Rob Worsham Senior Director, Manufacturing Science & Technology , Insmed

Synopsis

  • Considerations for continuous manufacturing design
  • What is the impact of formulation on continuous manufacturing?
  • Discussing the strategy for continuous manufacturing implementation

3:45 pm Continuous & Scalable Manufacturing of LNPs by Microfluidics

  • Dimitrios A. Lamprou Professor (Chair) of Biofabrication and Advanced Manufacturing , Queen's University Belfast

Synopsis

  • Understanding the benefits of using microfluidics – robustness, stability, heterogeneity, scalability
  • Using less solvents, scale up and scale out the manufacturing process
  • How to better control the homogeneity of LNPs and improve standardisation

4:15 pm Chair’s Closing Remarks & End of Summit

  • Shahid Uddin Senior Director of Formulation & Stability , Mendus