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

  • Weiyu Zhao Principal Scientist, Strand Therapeutics
  • Nikita Lomis Senior Scientist, LNP Process Development, Strand Therapeutics

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 Process Development & Manufacturing

Workshop G & H

Workshop G: 9.00-10.30

Discussing the Current Challenges With Process Development and LNP Drug Product Manufacturing

  • Ramesh Marasini Messenger Ribonucleic Acid-LNP Drug Development Lead Scientist, Walter Reed Army Institute of Research

Synopsis

  • Reviewing mRNA-LNP manufacturing
  • Identifying the process development steps for quality and quantity of drug product
  • Navigating the tech transfer from R&D to manufacturing

Workshop H: 10.30-12.00

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

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 Assistant Project Scientist, 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

LNP Characterization & Analytical Development

Workshop E & F

Workshop E: 1.00-2.30

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

Workshop F: 2.30-4.00

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

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

Synopsis

  • Utilising 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

Recommended job titles for this track:

Analytical Development, Bioanalytical, Characterization, Assay Development

4:00 pm Site Visit: RECIBIOPHARM IN WATERTOWN

Synopsis

Please join us at our Watertown facility to tour the site and see how we’re set up to manufacture mRNA, from plasmid to IVT to LNP formulation and fill/finish in one facility. We will have our SME’s on hand to answer your questions and will even be able to give you sneak peek of our continuous manufacturing process for mRNA. We hope to see you there!

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2024 FULL EVENT GUIDE
PRE-CONFERENCE LNP 101 DAY