Conference Day Two: Thursday 25th April

8:00 am Morning Coffee

8:55 am Chair’s Opening Remarks

  • Marcel de Vocht Director - Scientific & Drug Substance Development, Johnson & Johnson Services, Inc

Leveraging Continuous Platform Technologies to Accelerate mRNA Process & Manufacturing Efficiency to Bring mRNA Drugs to Patients Faster

9:00 am Harnessing Continuous mRNA Manufacturing Platforms to Accelerate Process Development & Improve Manufacturing Performance

  • Zoltán Kis Senior Lecturer & Associate Professor, University of Sheffield

Synopsis

  • Utilising continuous platform processes to accelerate development by bridging scales based on the Quality by Design approach
  • Implementing continuous IVT and downstream purification processes for increased productivity, consistent high quality and low cost manufacturing
  • Manufacturing process digitalisation by connecting production equipment and process models to our bespoke dashboard for big data analysis, visualisation and process automation

9:30 am Establishing Closed Continuous Manufacturing Systems to Maximise Process Efficiency & Reduce Costs

  • Harris Makatsoris Professor - Sustainable Manufacturing Systems, King's College London

Synopsis

  • How can we define a closed system for mRNA manufacturing?
  • How can a closed system be connected to a sterile system to maximise quality and reduce cost
  • Distinguishing the process control strategies of a closed manufacturing system in comparison to an open system

10:00 am Session Reserved for CATUG

Synopsis

Home

10:15 am Morning Networking Break

Spotlighting Drug Product Formulation & Manufacturing to Improve Yield, Quality & Stability

11:00 am Maximising Innovations in LNP Chemistries & Stability to Improve Drug Product Formulation & Manufacturing

Synopsis

  • Developing concrete GMP manufacturing and process control strategies for LNPs to facilitate mRNA therapeutic and vaccine routes to market
  • How can we navigate the patent landscape for drug formulation components to improve LNP stability?
  • Innovating and developing LNP formulations to improve mRNA payload optimisation whilst boosting its delivery purpose

11:30 am Overcoming RNase-Related Challenges through RNase-free Single-Use Assemblies and 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 fail
  • Elevating mRNA development and manufacturing processes by mitigating the risk of RNase contamination
  • Exploring the inhibition of RNase through ionised air targeted at enzymes, showcasing an innovative approach to safeguarding bioprocess integrity

11:40 am Roundtable Discussion: Managing & Implementing mRNA Potency Assays for Better Protein Detection to Advance the Development of Precision Medicines for Patients

  • Ashiqul Haque Research & Development & CMC Scientist, Ziphius Vaccines NV

Synopsis

  • How can we optimise current analytical assays to improve drug product assessment?
  • How can we improve the mRNA-LNP packaging ratio for improved drug efficacy?
  • What can be done to control and monitor lipid impurities to aid downstream purification and reduce immunogenicity for mRNA therapeutics?

12:00 pm Lunch Break & Networking

1:00 pm Fireside Chat: Exploring Monovalent & Multivalent Drug Product Manufacturing for Optimised Therapeutic Potential

  • Sukrut Somani Associate Director - Chemistry, Manufacturing, & Controls Drug Product, BioNTech AG

Synopsis

  • How can we advance and maintain drug product stability for prolonged efficacy and reduced degradation, by comparing stability of freeze-dried vs. lipid products?
  • What must be considered with multivalent drug product manufacturing for more complex formulations?
  • How can we define strategies for end of shelf-life specifications?

2:00 pm Afternoon Networking Break

Optimising & Advancing Technology Transfer for Accelerated mRNA Manufacturing to Facilitate Faster Patient Access to mRNA Vaccines

2:30 pm Highlighting Technology Transfer to CDMOs, Challenges & Best Practices to Propel mRNA Manufacturing

Synopsis

  • Bridging know-how from research and development to manufacturing to streamline and speed the transition
  • Highlighting the technical challenges in scalability and GMP-compliance from small to large scale batches during technology transfer to maintain mRNA quality, compliance and reduce cost
  • Leveraging what we learned during COVID-19 to enable rapid mRNA vaccine and therapeutic manufacturing

3:00 pm Equalising mRNA Manufacturing in Low- & Middle-Income Countries to Drive Global Access to mRNA Vaccines & Therapeutics

  • Cristina Bruno Consultant Messenger Ribonucleic Acid Technology Transfer & Programme Manager, World Health Organization - WHO

Synopsis

  • Equipping local communities with a specialised workforce to enable rapid roll out of mRNA vaccines in low- and middle-income countries
  • Improving and designing accessible manufacturing processes to produce safe and efficacious mRNA vaccines and therapeutics for patients globally
  • Overcoming the challenges of current mRNA manufacturing practices to promote sustainability

3:30 pm Chair’s Closing Remarks

  • Sukrut Somani Associate Director - Chemistry, Manufacturing, & Controls Drug Product, BioNTech AG

3:35 pm End of 2nd mRNA Process Development & Manufacturing Summit Europe