8:00 am Coffee & Light Breakfast
8:40 am Chair’s Opening Remarks
Delivering on the Regulatory Expectations for Successful mRNA-Based Therapeutics & Breakthroughs Modifying Protein Structures
8:45 am Panel Discussion: Reviewing Standards & Regulatory Requirements of the Analytical Field of mRNA-Based Therapeutics
Synopsis
- Delving into how to give evidence of a state of control and maintain regulatory compliance for your mRNA analytical techniques
- Revealing how to integrate the new novel mRNA analytical technologies to align to GMP guidelines
- Understanding how to standardize your mRNA analytical techniques to align to CQAs and CPIs to allow efficient and rapid approval
9:30 am The mRNA Capping Process & Analysis of Capping Efficiency & Impurities
Synopsis
- An overview of the mRNA capping process
- Novel cap analogs for stronger gene expression
- LC-MS based methods for capping efficiency and poly-A characterization
10:00 am Highlighting the Advancements in mRNA Poly (A) Tail Characterization to Enhance Efficacy
Synopsis
- Discussing the latest methods used to characterize the poly (A) tail to provide valuable information about the dynamics of mRNA regulation
- Uncovering new insights into the mechanisms underlying protein expression of the mRNA to pave the way for more effective treatments for a wide range of diseases
10:30 am Advancing LC-based Analytical Tools & Techniques for mRNA Analysis
Synopsis
- The benefit of ultra-low adsorption chromatography
- Tools and techniques for mRNA critical quality attribute (CQA) analysis
10:40 am Morning Break & Networking
Advancing mRNA Analytical Development Through Optimized LNP Formulation & Characterization to Enhance Stability & Delivery Efficacy
11:30 am Session Reserved for InDevR
Synopsis
12:00 pm Advanced Characterization Approaches for Quality Control of LNP Formulation
Synopsis
- What considerations should be taken into account when formulating LNPs for various types of therapeutic payloads, such as mRNA, siRNA, or small molecules?
- Addressing concerns related to immune response, biodistribution, and targeted delivery
- What strategies can be employed to improve the encapsulation of mRNA molecules within LNPs?
12:30 pm Maximizing the Strategies for Enhancing LNP Stability & Payload Loading
Synopsis
- Innovations in lipid selection and engineering for improved LNP stability
- Approaches to optimize mRNA loading and release kinetics
- Exploring the influence of lipid components, ratios, and modifications on LNP stability and mRNA delivery
1:00 pm Advancement in mRNA Therapeutics and Vaccines: Overcoming RNase-Related Challenges through RNase-free Single-Use Assemblies & Non-Thermal Plasma-based Inhibition
Synopsis
- Pioneering Non-Thermal Plasma inhibition of RNases as a cutting-edge alternative for ensuring RNase-free single-use bioprocess containers and assemblies, when conventional methods like thermal, irradiation and chemical inactivation fail
- Elevate mRNA development and manufacturing processes by mitigating the risk of RNase contamination
- Exploring the inhibition of RNase through ionized air targeted at enzymes, showcasing an innovative approach to safeguarding bioprocess integrity
1:10 pm Lunch & Networking
2:00 pm A Tale of Tails: Using the Power of Capillary Electrophoresis for the Analytical Characterization of mRNA
Synopsis
- Development of a robust CGE workflow for mRNA poly(A) tail characterization achieving single-nucleotide resolution
- Supports diverse poly(A) tail assessments without optimization required for LC gradient methods
- QC-friendly method well suited for release testing of mRNA therapeutics and vaccines
2:30 pm mRNA Analytical Development Update from Gennova
Synopsis
- Updates on the investigational mRNA analytical development techniques
- Optimizing mRNA analytical development techniques to bring mRNA therapeutics to patients in need
3:00 pm Afternoon Break & Refreshments
Advancing mRNA Analytical Development Through Optimized LNP Formulation & Characterization to Enhance Stability & Delivery Efficacy
3:30 pm Optimizing Analytical Techniques for LNP Characterization to Avoid Impurities & Uncertainties
Synopsis
- Exploring the techniques to assess LNP size, charge, encapsulation efficiency, and payload release kinetics
- Addressing the importance of reliable analytical methods in guiding formulation optimization
- Discussing how impurities can affect LNP stability, therapeutic delivery, and patient safety
4:00 pm Analysis of Uncapped & 5’ Cap Structures of In Vitro-Transcribed mRNA Using LC-MS & LC-UV Methods
Synopsis
- Overview of methods used for the generation of 5’-end fragment of mRNA
- Optimization of Ribozyme assay to generate 5’-end fragment of mRNA
- Development and optimization of reversed phase chromatography method for the separation of uncapped and cap structures of mRNA
4:30 pm Novel Stability-Indicating Method for the Simultaneous Determination of RNA & DNA Co-Loaded in a Single LNP
Synopsis
- Development of a stability-indicating method is crucial for assessing the integrity and quality of RNA and DNA co-loaded in LNPs
- This novel stability-indicating method provides a valuable tool for researchers and industries working with RNA and DNA-loaded LNPs, ensuring the reliability of their formulations