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

  • Michael Rieger Head of mRNA Process, Chemistry, Manufacturing & Controls Data Science, Sanofi

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

  • Rok Sekirnik Head Process Development, mRNA, pDNA, Sartorius BIA Separations

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 Session Reserved for Quantoom Biosciences

Synopsis

BioPark - The Science - Driven BioPark at the heart of Europe - News -  Single News Details - eTheRNA immunotherapies and Quantoom Biosciences  Announce a Strategic Collaboration for the Development of

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 Session Reserved for Exothera Nucleic Acids

Synopsis

Exothera SA - CMOCRO

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

  • Simon Unthan Senior Director RNA Manufacturing Technology Development & Automation, BioNTech SE
  • Prasun Chakraborty Founder, Innovator & Chief Executive Officer, Genevation LTD.
  • Zoltán Kis Assistant Professor & Lecturer, University of Sheffield
  • Harris Makatsoris Professor - Sustainable Manufacturing Systems, King's College London

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

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 Session Reserved for Syngoi

Synopsis

SYNGOI TECHNOLOGIES – Columbus Venture Partners

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

4:55 pm Chair’s Closing Remarks

5:00 pm End of Conference Day One