Conference Day Two
Friday, November 8, 2024
8:45 am Chair’s Opening Remarks
Developing a Robust Potency Assay to Reflect the Mechanisms of Action & Total Functionality of the LNP
9:00 am Driving Translatability of Assay Development, Pinpointing In Vitro to In Vivo Potency Correlations
Synopsis
- Reducing the gap between in vitro and in vivo assay readouts to drive seamless clinical progression
- Conducting thorough assessment for in vivo potency definition to mimic such conditions in vitro
- Underpinning the fundamental mechanisms of action in vitro to gain a firm understanding of what should be expected in vivo
9:30 am Building Robust Molecular & Cellular-Based Assays for mRNA & gRNA Encapsulated Lipid Nanoparticles
Synopsis
- Characterizing priority assays which are pivotal to validate the key mechanisms of action
- Showcasing the shift in approach to potency assay development when handling co-formulated lipid nanoparticles
- Overcoming the challenges faced when utilizing cell-based assays to minimize sample variability
10:00 am Session Reserved for Nanofcm
Synopsis
10:15 am Morning Refreshments & Speed Networking
Benchmarking Analytical Requirements Across Phase Development & Enlightening Optimal Cross Departmental Communication
10:45 am Roundtable Discussion: Designing a Matrix of Potency Assays to Create an All-Encompassing Model of Functionality
Synopsis
- Implementing a widespread assay development plan across early stages to gather a vast array of data points
- Revealing the vital assays required to advance the analytical development of the drug product, and those which lack importance
- Outlining the process of tailoring the potency matrix as the drug product progresses through the clinic
11:15 am Navigating the Analytical Journey from Early Stage to Late-Stage Development To Ensure Seamless Progress
Synopsis
- Discussing with formulation and process development teams to fully grasp the mechanistic detail of the lipid nanoparticle drug product
- Relaying this information to customize the analytical toolbox to ensure the required data is extracted to inform the success of the process
- Evolving this analytical strategy as knowledge of the product develops, to ensure the highest quality metrics are consistently available
11:45 am Panel Discussion: Streamlining the Relationship Between Analytical Development & Quality Control To Align in Product Expectations
Synopsis
- Focusing the necessary relationship between quality control and analytical development teams to ensure alignment in development goals
- Outlining the required touchpoints through phase development which require deeper discussion to ensure the quality of drug product remains consistent
- Implementing a robust feedback model to ensure transparency between QC and analytical development departments throughout phase development
12:30 pm Lunch & Networking
Comparing the Array of Technology Available to Curate a Thorough Analytical Profile
1:30 pm Roundtable Discussion: Reviewing the Current Technological Pitfalls Experienced Throughout the Field, Preventing Holistic Characterization
Synopsis
- Investigating the future of LNP characterization and analytical development with promising emerging technologies
- Discussing the strengths and limitations of current analytical tools in market
- Comparing the technologies currently in use with academic institutions in comparison with those across pharma and biotechnology companies
2:15 pm Advanced Analytical Methods for the Chemical & Structural Characterization of Lipid Nanoparticles
Synopsis
- Introducing advanced cryogenic-aided surface chemical analysis for the measurements of lipid nanoparticles
- Expanding on advanced methods for the chemical analysis of complex and advanced therapeutics
- Discussing the current state of the art, needs and gas in standardization of analytical methods for lipid nanoparticles and development of relevant reference materials
2:45 pm Creating a Definitive Tool To Quantify the Degree of Encapsulation with In- Depth Empty vs Full Analytics
Synopsis
- Benchmarking the percentages of empty LNPs within a sample which can still provide potent delivery with no adverse effects
- Implementing characterization techniques to quantify the degree of encapsulation across a lipid nanoparticle sample
- Highlighting the degree of encapsulation required to classify a lipid nanoparticle as ‘full’ to standardize dosage