Conference Day One: Wednesday 24th April
8:00 am Morning Registration & Coffee
8:55 am Chair’s Opening Remarks
Improving Purification Through Novel Techniques to Battle Contaminants for Optimised mRNA Quality & Yield
9:00 am Optimising & Innovating Purification Techniques to Increase mRNA Quality & Yield
Synopsis
- Understanding how to optimise current chromatography strategies to reduce dsRNA and improve mRNA quality
- Ensuring GMP-compliance with purification techniques to aid their implementation in late-stage development
- Implementing digital twin modelling for optimised chromatography techniques to predict and control quality in real-time
9:30 am Highlighting a Combined Mechanistic Modelling & Machine Learning Approach to the IVT Reaction to Improve mRNA Yield & Process Controls to Aid Downstream Purification
Synopsis
- Learning how a hybrid modeling approach improve process controls and understanding
- Utilising digital twin modelling as key ingredient to a Quality by Design manufacturing approach
- Demonstrating how model-driven optimisation leads to a higher mRNA purity to facilitate downstream purification
10:00 am Increasing Productivity of mRNA Production Through Integration of At-Line Analytics
Synopsis
- Design of IVT reaction through DOE supported by at-line HPLC monitoring significantly enhances mRNA production efficiency and cost-effectiveness.
- Oligo dT affinity purification with CIM monolith demonstrates consistent performance independent of residence time or mRNA size with high yield and purity, offering fast processing times
- Scalable removal of residual dsRNA, abortive fragments and residual template is shown with SDVB monolith
10:30 am Morning Break & Speed Networking
Accelerating Scalability of Process Development from Small to Large Scale to Bring mRNA Therapeutics for All Diseases to Patients Faster
11:30 am Rapid & Scalable Processes to Achieve CEPI’s 100-Day Mission for Faster Roll Out of mRNA Vaccines & Therapeutics
Synopsis
- Implementing mRNA vaccine technology for rapid response vaccine manufacturing
- Standardising technology transfer to reduce risk of comparability for faster scale up
- Highlighting assay standards across the drug product development lifecycle
12:00 pm NtensifyTM Technology – Ever Dreamed of a Simple, Scalable & Cost-Efficient Way to Produce mRNA Vaccines?
Synopsis
- NtensifyTM technology provides a tailored solution for mRNA vaccine developers across the entire product development journey
- NtensifyTM offers a de-risked construct-agnostic mRNA process ensuring high yields and quality, reduced reagent consumption, and minimized resource-intensive scale-up needs
- NtensifyTM solution yields mRNA vaccines with no safety concern, yet able to elicit directed immune response
12:30 pm Overcoming Hurdles with Scaling Processes Down & Out to Better Manufacture mRNA-Based Vaccines for Personalised Medicine
Synopsis
- Accelerating small scale batch production using different starting DNA sequences to reduce time and cost
- Optimising parameters to enable scaling down of equipment for batch-to-batch production of mRNA vaccines and therapeutics for personalised medicines
- Effectively scaling process development for personalised medicines for larger patient populations, using current process procedures
1:00 pm Lunch Break & Networking
2:00 pm Revolutionizing mRNA Production: The Paradigm Breaking Nfinty™ Continuous-Batch RNA System
Synopsis
- Showcasing the world’s first continuous-batch RNA manufacturing system
- Demonstrating a construct agnostic process for high quality drug substance
- No scale up required due to a radical redesign of the process
- Simplified, integrated, automated workflow in a single system enabling mg to kg production
2:30 pm Panel Discussion: Developing Flexible Platform Technologies to Enable Scale Up or Down to Enable Roll Out of mRNA Vaccines & Therapeutics to Patients Faster
Synopsis
- How quickly can a small batch size be upscaled to enable rapid roll out of manufacturing for emerging and future health threats?
- Can we leverage current large scale platform technologies for smaller scale process development and manufacturing for personalised mRNA drugs?
- How can we achieve process control strategies that fit a flexible platform for improved and standardised parameters?
3:30 pm Empowering Enzymes for mRNA Optimised Manufacturing
Synopsis
- INOFEA’s technology empowers enzymes to make them fit for industrial processes
- Our comprehensive toolbox for enzymes meets the industrial expectations of mRNA development and manufacturing in terms of reaction efficiency and product quality
- INOFEA teams up with industrial partners in various sectors to co-develop tailor-made solutions
3:40 pm Afternoon Networking Break & Poster Session
Implementing New Innovations to Boost the Starting Material to Enable Advanced & Improved mRNA Manufacturing
4:15 pm Optimised Linear Synthetic DNA as GMP Starting Material to Improve mRNA Production & Delivery Times
Synopsis
- Understanding how to reduce delivery times of GMP DNA template to 6-8 weeks instead of waiting 8 months for a pDNA template
- Increasing mRNA production yield by three times with high purity
- Reducing the mRNA cost by 40%
4:25 pm Highlighting Advances in Plasmid DNA Manufacturing to Accelerate Scale Up & Aid Downstream Process Steps
Synopsis
- Highlighting the latest advances in plasmid DNA manufacturing to optimise downstream steps
- Optimising scale up of plasmid manufacturing to accelerate processes from small to large batches
- Tackling hurdles in plasmid DNA internalisation and externalisation to produce improved drug substance