Conference Day One

7:50 am Registration & Morning Networking Coffee

8:50 am Chair’s Opening Remarks

Overcoming Barriers to Achieve a Flexible & Continuous mRNA Manufacturing Process

9:00 am Introducing Flexibility in the Production of mRNA Therapeutics & Vaccines to Optimise their Function

  • Tilmann Roos Senior Director of Technical Solutions, CureVac


  • Discussing the key process parameters that introduce flexibility to produce different constructs from a standard platform
  • Altering the critical process steps to achieve a flexible manufacturing process
  • Outlining potential risks to the drug substance resulting from a flexible manufacturing process

9:30 am Panel Discussion: Understanding the Viability of a Cost-Effective Continuous Manufacturing Platform


  • Sharing recent successes and failures in the development of continuous manufacturing platforms for mRNA therapeutics and vaccines
  • Identifying major bottlenecks in the development of continuous manufacturing platforms for mRNA therapeutics and vaccines
  • Assessing the cost/benefit trade-off of a continuous manufacturing platform

10:30 am Development of In-Process Analytics to Enable Robust mRNA Manufacturing


  • Typical mRNA production process involves four key steps: 1) plasmid DNA (pDNA) expression in E.coli, linearisation and pDNA purification, 2) in-vitro transcription (IVT) reaction, 3) mRNA purification and 4) mRNA encapsulation
  • In this paper a chromatographic toolbox and optimised IVT synthesis, including instant in-process analytics, will be presented
  • This well controlled and high IVT yield process reduces the overall number of purification steps, improves recoveries, results in extra low protein and dsRNA impurity levels and allows for rapid scale-up and straightforward tech transfer to different manufacturing sites

11:00 am Morning Break & Speed Networking


As the mRNA community is united, this valuable session will ensure you can connect with your peers in the room to make new and lasting connections. Also, don’t forget to enjoy some refreshments before we come back after the break!

Uncovering Process Development Considerations to Optimise Drug Substance Quality

12:00 pm Revealing Critical Quality Attributes for mRNA Therapeutics & Vaccines


  • Uncovering applications of liquid chromatography-mass spectrometry to analyse mRNA therapeutics and vaccines
  • Using mass spectrometry for rapid sequence mapping and identity testing of mRNA
  • Analysing polyA tail length/distribution and 5' capping efficiency using mass spectrometry

12:30 pm Comparison of Maglev Centrifugal and Diaphragm (4 Piston) Pumping Effects on mRNA Encapsulated LNP


  • Revealing Equipment selection criteria and considerations for transferring mRNA encapsulated LNPs, while maintaining CQAs
  • Evaluating the impact of prolonged recirculated pumping to the mRNA encapsulated LNP fluid stream to mimic worst case TFF manufacturing operations
  • Assessing the impact of across a range of maglev centrifugal and diaphragm (4 piston) pumps on mRNA and LNP degradation in recirculated applications.

1:00 pm Understanding the Differences in Process Development Considerations for mRNA Therapeutics & Vaccines to Achieve Appropriate Drug Substance Quality


  • Exploring differences in critical quality attributes for mRNA therapeutics and vaccines
  • Unpacking unique critical process steps for mRNA therapeutics and vaccines to achieve this quality
  • How might this accelerate novel drugs into the clinic?

1:30 pm Networking Lunch

Spotlight on Process Development Advances to Improve Process Efficiency & Cost Effectiveness for Different mRNA Types

2:30 pm Exploring How Template Stability and Quality Control Impacts Purity and Efficacy of mRNA Drug Products

  • Taylor Scott Senior Scientist, Process Development, GeneLeap BioTech


  • Evaluating template quality and suitability for mRNA production
  • Understanding the effects of template quality on mRNA purity and functionality
  • Exploring design considerations to maximise template stability

3:00 pm Unlocking Access to mRNA-Based Vaccines & Therapeutics


  • Outlining a simple, scalable, and cost-efficient way to intensify and chain manufacturing steps for continuous and automated production
  • Significantly reducing the footprint to enable high portability and optimise the use of expensive cleanroom space, while minimising manual steps to improve safety and product quality to the highest levels
  • Improving the availability of expensive biologics, particularly for LMICs

3:30 pm Afternoon Networking Break

Understanding Scalability to Transition from Small to Large Scale Manufacturing to Meet Global Demands

4:00 pm Scale Up of Reliable Commercial Manufacturing Processes for Parenteral Drug Products

  • Mostafa Nakach Global Head Of Process Engineering & For Biologic Drug Product Development, Sanofi


  • Discussing the scale-down/scale up considerations when bringing an mRNA product to the clinic
  • What are the requirements for successful scale up?

4:30 pm Flexible and scalable solutions for mRNA production, from discovery to clinic


  • Introducing an automation-ready magnetic bead-based workflow for mRNA synthesis and purification
  • Reducing manufacturing footprint by reuse of template in modular in-vitro transcription reactions
  • Navigating through scale-up and scale-down strategies to ensure a smooth mRNA process development

5:00 pm Capping the Budget: Novel Solutions to Reduce the Cost of 5’ Capping


  • Outlining the potential solutions to eliminate this bottleneck
  • How would altering the 5’ capping process affect the upstream and downstream process steps?
  • Determining how much capping should be carried out

5:30 pm Chair’s Closing Remarks

5:45 pm End of Conference Day One