8:00 am Check-In & Light Breakfast
8:50 am Chair’s Opening Remarks
Optimising Different Techniques Used for Accurate mRNA Characterisation to Enhance Efficiency & Accuracy in Order to Achieve Robust Results
9:00 am Unlocking the Importance for Adaptability for Release Assays & Navigating the Regulatory Seas For The Development of Effective mRNA Vaccine
Synopsis
- Could we consider the current mRNA vaccine regulatory landscape as foggy?
- Emphasize the importance of adaptability in the context of fast changing environment
- How can we differentiate the release and characterisation assays for mRNA vaccines?
- Using Analytical Platform Technologies and life cycle management to support accelerated mRNA vaccines development
9:30 am Roundtable Discussion: Navigating Existing Standards & Regulatory Requirements for Analytical Development of mRNA Vaccines to Ensure a Streamlined Approval
Synopsis
- Delving into the quality issues regarding mRNA vaccines and how we can overcome them
- Discussing what is expected by the regulatory agencies for the clinical and non-clinical requirements
- Understanding the regulatory guidelines for CMC’s and manufacturing testing to allow a streamline approval
- Exploring the advances of having a platform approach for vaccines to allow a more rapid approval of your mRNA vaccines
10:30 am Morning Break & Speed Networking
Synopsis
This session is your opportunity to get face-to-face time with many of the brightest minds working in the mRNA Analytical Development field, and establish meaningful business relationships to pursue for the rest of the conference.
Overcoming Production Hurdles for mRNA to Improve Quality & Achieve High Purity Samples
11:30 am Integrity Analysis of mRNA: Characterisation of Break-off Transcripts & Degradation Products
Synopsis
- Molecular integrity of therapeutic mRNAs is essential for their functionality, and understanding of product-related impurities is important to ensure product quality.Â
- Approaches to analyze mRNA integrity by liquid-chromatography with UV and mass spectrometric detection will be presented.
- Aim: Improve understanding of species derived from full-length mRNA
12:00 pm Roundtable Discussion: Innovations in Addressing dsRNA Challenges to Develop More Precise, Potent, & Safer mRNA Therapies
Synopsis
- Understanding dsRNA ability to effectively target specific mRNA sequences, resulting in increased specificity and accuracy in mRNA analysis
- Discussing the possible strategies to improve its specificity and reduce the potential for off-target effects
- Addressing the regulatory hurdles in the use of dsRNA in mRNA analytical development to ensure safety and efficacy of these technologies
1:00 pm Overcoming dsRNA Challenge: Innovation in Assays & Enzyme
Synopsis
- Current status of mRNA therapeutic drugs: dsRNA can strongly stimulate the intracellular RNA receptors RIG-I and MDA5, activate the innate immune response, and cause inflammation. Therefore, the content of dsRNA is related to the safety and efficacy of vaccines
- mRNA therapeutic drug process development challenges and solutions:It will describe the dsRNA quantitative detection and process control challenges encountered during development, and propose solutions to overcome these challenges
- Vazyme’s work in mRNA raw materials and process innovation:GMP Grade,DMF Record
1:30 pm Networking Lunch
Enhancing Stability, Efficacy & Potency to Produce Safe & Effective mRNA Therapies
2:30 pm Development of Analytical Methods to Support mRNA Manufacturing & mRNA Characterisation
Synopsis
- Development of novel rapid AEX HPLC methods to monitor IVT reactions to support mRNA manufacturing
- Direct mRNA sequencing using mass spectrometry
- Future directions for expanding the analytics toolbox to support mRNA manufacturing and mRNA characterisation
3:00 pm Introducing Advanced Biophysical Characterisation Methods to Quality Control of mRNA Pharmaceuticals
Synopsis
- What are the advanced biophysical characterisation methods
- What are the principles of biophysical techniques
- How do you apply biophysical methods in assessing mRNA stability, structure, and purity
Virtual Presentation
3:30 pm Exploring the Recent Advances in Capillary Electrophoresis & Their Impact on Analytical Chemistry to Streamline Development
Synopsis
- Investigating the advantages of using capillary electrophoresis over current methods to get high sensitivity and the ability to analyze samples with low volumes
- Discussing the development of new analytical methods for the characterisation of interactions between antigens and adjuvants in vaccines by capillary electrophoresis
- Reviewing what is in store for the future of capillary electrophoresis and its potential for speeding up analytical methods