Pre-Conference Workshop Day
Tuesday 18th November 2025
7:30 am Check-In & Light Breakfast
8:30 am Workshop A – Providing a Comprehensive Overview of Core Analytical Methods & Assays for Successful Regulatory Submissions & Batch Release of LNP-Mediated Drugs
Synopsis
Unlock the fundamental and critical analytical strategies behind successful LNP drug development in this hands-on 101 workshop. Gain a clear understanding of essential QC release assays, enabling accurate execution to meet regulatory expectations and confidently drive your LNPs from lab to market.
- Delving into a regulatory-focused list of required QC release assays for robust regulatory submissions
- Uncovering the go-to analytical methods, such as Ribogreen assays and DLS, for assessing LNP physicochemical properties
- Learn how to accurately assess potency and purity of LNP-mediated drugs to ensure regulatory compliance and approval
10:30 am Morning Networking Break
11:00 am Workshop B – Improving the Standard QC Release Assays by Overcoming Their Limitations to Ensure Accurate & Precise Analysis of LNPs
Synopsis
As LNP-mediated medicines continue to advance, the need for more precise, robust and sensitive QC release assays has never been greater. This workshop will take a critical look at the limitations of the current standard methods and examine the emerging orthogonal analytical techniques that can complement or replace existing assays to improve data quality and regulatory confidence.
- How to overcome the bias of the state-of-the-art analytical methods towards larger LNPs?
- Designing a regulatory submission that optimally showcases accurate analysis and characterization of LNP drug products
- Uncovering orthogonal techniques that can overcome the limitations of the gold standard analytical methods such as Ribogreen and Dynamic Light Scattering
1:00 pm Lunch & Networking
2:00 pm Workshop C – Leveraging Heightened Characterization Strategies for Deeper Understanding of LNP Products to Accelerate Safe & Effective Drugs to the Patients in Need
Synopsis
During this workshop explore how advanced characterization techniques can be robustly integrated into LNP development workflows to enhance morphology analysis, derisk formulation, and support regulatory submissions. Learn how to build an efficient, multi-modal analytical pipeline to accelerate safe and effective drug delivery to patients.
- How to robustly implement heightened characterization methods into your workflow for better LNP morphology analysis?
- How to derisk formulation and process development by leveraging advanced characterization techniques?
- Building an efficient pipeline of advanced characterization methods to complement your regulatory submissions