Conference Day Two: Thursday 25th April
8:00 am Morning Coffee
8:55 am Chair’s Opening Remarks
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
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
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 Plasmid DNA: How Good is Good Enough for mRNA Production?
Synopsis
- Supercoiled DNA percentage is a key in-process control of linear DNA template for mRNA drug substance manufacturing
- Open circular DNA in plasmids caused by nicks, though won’t be reflected by the linear DNA purity, will directly impact mRNA major CQA as well as key process yield
- Four different processes, covering enzymatic capping and co-transcriptional capping, as well as non-affinity purification and affinity purification have been investigated
- The findings contribute insights into in-process control strategy for linear DNA template production and the determination of suitable processes for mRNA manufacturing
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
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?
12:10 pm Lunch Break & Networking
1:10 pm Fireside Chat: Exploring Monovalent & Multivalent Drug Product Manufacturing for Optimised Therapeutic Potential
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
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