Conference Day One

Thursday, November 7, 2024

7:45 am Check In & Morning Coffee

8:45 am Chair’s Opening Remarks

Focusing the Complexities of Lipid Nanoparticles to Comprehensively Characterize Structural Properties

9:00 am KEYNOTE ADDRESS: Examining the Quantification Metrics Available To Characterize Size, PDI & Zeta Potential of Lipid Nanoparticles

Synopsis

  • Outlining the technology available to quantify the size and zeta potential of the lipid nanoparticle within a sample
  • Analyzing size dispersity with the target site central to discussion to ensure maximal uptake through the pores
  • Creating novel quantitative biophysical characterization techniques, magnifying size and structure, as well as dynamic properties

9:30 am Debunking the Assumptions of Protein Corona Formation Around the Lipid Nanoparticle To Understand the Components Responsible for the Association

Synopsis

  • Characterizing the protein corona to understand the composition of protein and how this relates to LNP outcome
  • Researching the lipid components which correlate with specific protein corona formations
  • Magnifying oxidation of lipids as a potential cause of an advanced protein corona cascade

10:00 am Session Reserved for BA Sciences

Synopsis

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10:30 am Morning Refreshments & Speed Networking

Collating In-Depth Pre-Clinical Characterization Data Packages to Inform LNP Formulation

11:30 am Developing a Thorough Process To Analyze & Screen the Lipid Components of the Lipid Nanoparticle To Ensure Stable Formulations

Synopsis

  • Exploring the essential factors in the lipid screening process to enhance characterization
  • Addressing the current obstacles in the lipid screening and discovery field to support lipid nanoparticle formulation
  • Utilizing advanced automated and high-throughput microfluidic technologies for efficient lipid screening

12:00 pm Screening the Profile of Surface Functionalized Lipid Nanoparticles To Understand the Impact on Delivery

  • Ronald Toth Associate Director, Characterization, Sanofi

Synopsis

  • Implementing a thorough method to characterize the variety of targeting moieties available to lipid nanoparticles
  • Adequately characterizing the chemical structures and density of the surface markers
  • Relaying the characterization data to grasp the impact the surface structure has on delivery outcomes

12:30 pm Mapping the Relationships Between Critical Quality Attributes To Define the Data Points of True Importance

  • Chris Broomell Head of Analytical Development, Omega Therapeutics, Inc.

Synopsis

  • Outlining the current definition of ‘critical quality attributes’ to prioritize characterization efforts
  • Digging deeper to uncover the ‘why’ behind certain readouts and what this means to the functionality of the lipid nanoparticle
  • Interconnecting critical quality attributes to comprehend the dynamic relationship between such measurements

1:00 pm Session Reserved for Partner Presentation: Anton Paar

Synopsis

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1:15 pm Lunch & Networking

Maximizing Control Through Standardized Sample Preparation & Aligning Process Development Requirements

2:15 pm Reconsidering the Structural & Dynamic Measurements Responsible To Extensively Quantify Stability

Synopsis

  • Brainstorming methods to quantify the stability profile of the lipid nanoparticles with varied formulation and manufacturing processes
  • Pinpointing the key morphological properties of lipid nanoparticles which play a role in the stability outcome of the nanoparticle
  • Considering the dynamic properties which can trigger instability and installing methods to measure these interactions over a prolonged period

2:45 pm Spotlighting the Structural & Dynamic Properties of the Lipid Nanoparticle which are Predictive of Storage & Temperature Requirements

Synopsis

  • Leveraging the early analytics required to indicate the manufacturing steps in later development, including temperature and storage controls
  • Characterizing the factors which contribute to temperature instability within lipid nanoparticles
  • Working collaboratively with process development teams to allow for analytics to indicate the process

3:15 pm Panel Discussion: Benchmarking Gold Standard Analytical Sample Preparation Standards To Mitigate Variability

Synopsis

  • Preparing a lipid nanoparticle sample which is representative of the true sample to avoid discrepancies
  • Establishing a process to ensure the entirety of the sample is being quantified to ensure maximal control
  • Standardizing sample preparation, material handling and method robustness to increase the reliability of analytical practices

4:00 pm Afternoon Refreshments & Networking

Managing the Diverse Interactions with LNP Components & the Payload, Indicating the Endosomal Release Outcome

4:30 pm Characterizing the Lipid to Payload Interaction within the Nanoparticle, Providing Clarity in the Encapsulation Dynamics

  • Zhinan Xia Chief Scientific Officer, Abimmmune Bio

Synopsis

  • Focusing the dynamics behind payload to lipid association to understand the degree of interaction within the lipid nanoparticle
  • Quantifying the dispersity of payload across a lipid nanoparticle to understand the location of the drug substance
  • Reviewing the differences in characterization across varying payloads, from RNA to CRISPR to cell therapies

5:00 pm Overcoming the Bottlenecks Associated with Co-Formulated Lipid Nanoparticles to Successfully Differentiate the Encapsulated Material

  • Yi Pu Group Head, Prime Medicine

Synopsis

  • Introducing the formulative approach to develop a co-formulated lipid nanoparticle
  • Showcasing the challenges faced when characterizing the internal dynamics of 2 payloads of varying size and compositions
  • Generating metrics to accurately record the ratios of payloads within a lipid nanoparticle

5:30 pm Chair’s Closing Remarks

5:45 pm End of Day One