Pre-Conference Workshop Day: Monday, April 29, 2024

LNP Discovery
& Screening

Workshop A: 9.00 – 12.00

Navigating the Complex Lipid Library Available for LNP Formulation with An Understanding of Lipid Properties

Synopsis

  • Encompassing the role of lipid components in LNP size, structure, stability, PKa, encapsulation efficiency and endosomal release
  • Understanding the key functions of ionizable cationic lipids regarding LNP encapsulation of payload and eventual endosomal release
  • Running advanced screening strategies to generate a through lipid profile, minimizing risk of instability and impurity of the LNP

Recommended job titles for this track:

LNP / Lipid Discovery, LNP Screening, Particle Engineering, LNP Chemistry

LNP Formulation &
Delivery

Workshop C: 9.00 – 12.00

Reviewing the Compositions of LNPs & Opportunities for Tissue-Specific Delivery

Synopsis

  • Overviewing therapeutic applications of LNP delivery
  • Discussing compositions of LNPs and opportunities for modifications towards different therapeutic applications
  • Projecting future of advancing tissue / cell specific LNP delivery

Recommended job titles for this track:

Pre-Formulation, Delivery, Formulation, Stability, Drug Substance

LNP Characterization & Analytical Development

Workshop E: 9.00 – 12.00

Debating the Current Pitfalls Across Analytical Technology & Required Advancements to Progress LNP Understanding

  • Mark Brader Biotech Product Development Scientist Group Leader, Moderna

Synopsis

  • Discussing the required next steps in the development of analytical technology to advance LNP functional understanding of heterogeneity
  • Critiquing the technology currently accessible to industry to establish what data is available for analytical teams, considering the nanostructure of LNPs
  • Evolving analytical techniques to accommodate for the next wave of LNPs as innovative methods provide fresh analytical considerations, specifically the complexity of non-covalent phenomena

Recommended job titles for this track:

Analytical Development, Bioanalytical, Characterization, Assay Development

LNP
Process Development & Manufacturing

Workshop G: 9.00 – 12.00

Discussing the Current Challenges With LNP Drug Product Manufacturing

  • Ramesh Marasini Scientist, mRNA Drug Product Development, Walter Reed Army Institute of Research

Synopsis

  • Navigating the tech transfer from R&D platform to manufacturing to avoid financial and timing inefficiencies
  • Identifying the process development steps for quality and quantity of drug product
  • Implementing consistency in process design between platforms with differing technology to accommodate for LNP design

Recommended job titles for this track:

Manufacturing, GMP, CMC, QC, QA, Tech Transfer, MSAT, Process Development, Process Optimization, Drug Product

12:00 pm Networking Lunch

Workshop B: 1.00 – 4.00

Screening the LNP Delivery Outcome Across Varying Models Available for Research

  • Rohit Sharma Postdoctoral Scholar, University of California, Berkeley

Synopsis

  • Balancing potency and toxicity considerations when screening LNPs
  • Translating toxicity findings across models to in vivo human trials to ensure safety of product
  • Maximizing experimental findings in in vitro studies to form a foundation of understanding to translate in vivo

Workshop D: 1.00 – 4.00

Removing Liver from Deliver – Innovative Approaches to Extra-Hepatic LNP Delivery

  • Stephan Stern Laboratory Co-Director, Director of Research & Development, Nanotechnology Characterization Laboratory, Frederick National Laboratory for Cancer Research
  • Ruvanthi Kularatne Scientist II, Frederick National Laboratory for Cancer Research
  • Jeffrey Clogston Principal Scientist, Frederick National Laboratory for Cancer Research

Synopsis

  • Reaffirming LNP lipid composition as a key contributing factor to the binding of apolipoprotein E, resulting in increases hepatic delivery
  • Combining research of lipid carriers and lipid composition of LNP to maximize specificity of LNP carrying to target organs
  • Addressing the emerging ligands available for LNP formulation which provide promise for accurate delivery

Workshop F: 1.00 – 4.00

Defining The Empty LNP & Benchmarking the Standardized Metrics Across a Sample

  • Sixuan Li Graduate Research Assistant, Johns Hopkins University
  • Yizong Hu Postdoctoral Associate, Massachusetts Institute of Technology

Synopsis

  • Utilizing analytical techniques to quantify distribution of payload across an LNP sample, establishing a full vs empty ratio
  • Introducing size-based separation technique to the single particle analyzer to quantify the size of LNP, differentiate empty LNPs from RNA-loaded LNPs
  • Correlating LNP content with LNP size, and revealing their heterogeneity 

Workshop H: 1.00 – 4.00

New Oral Delivery Platform to Treat Ulcerative Colitis

  • Chunhua Yang Assistant Professor, Georgia State University
  • Didier Merlin Regents University Professor, Georgia State University

Synopsis

  • Need for a new therapy to treat ulcerative colitis.
  • Developing a new type of well-defined lipid nanoparticles (LNPs) through reverse engineering.
  • Successfully orally deliver new LNPs loaded with mRNA to treat ulcerative colitis.