7:15 am Registration & Morning Networking Coffee
8:05 am Chair’s Opening Remarks
Unravelling Upstream & Downstream mRNA Process Development to Achieve Efficient Bench to Clinic & Clinic to Commercial Scale Production
8:15 am Redefining Scale-Up Challenges from Bench to Clinic & Beyond
Synopsis
- Step by step or jump big? – Accelerating requirements across the product life cycle
- Identifying how critical quality attributes change to ensure effectivity at a larger scale
- Improving sensitivity between upstream and downstream processes and equipment to ensure appropriate method scale-up
8:45 am End-to-End Solutions for mRNA vaccines and therapeutics
Synopsis
- Accelerate the development and manufacturing of mRNA vaccines
and therapeutics - Products and services to support R&D through commercialization
- Clinical trial and regulatory support
9:15 am Going Beyond Vaccines – Next-Generation mRNA Drug Substance & Technology Transfers
Synopsis
- Current challenges and opportunities delivering mRNA as therapeutics vs. vaccines
- Novel & rapid approaches for drug substance platform development
- mRNA Modality-based technology transfer, scale-up and manufacturing
9:45 am Development of a Manufacturing-Ready Scalable Platform for (sa)mRNA-LNPs
Synopsis
- Introduction to case studies that outline platform development at CPI
- Development of an extensive toolbox of analytical methods to assess product quality
- Overview of CPI’s expertise and offering in the design and development of RNA platform processes
10:00 am Morning Break & Speed Networking
Unlocking CMC & GMP-Compliant Manufacturing Processes to Improve mRNA-Based Drug Production
11:00 am CMC Strategy for Advancing mRNA Therapeutics for Rare Diseases
Synopsis
- Considerations and challenges using mRNA for rare disease indication
- Improving integrity and reducing impurities in drug substance development
- Considerations in early and late-stage CMC development
11:30 am Platform Manufacturing Process of any Size & Form of mRNA
Synopsis
- Improved IVT and mRNA purity
- Supported by at-line HPLC methods
- Turnkey manufacturing process from pDNA to mRNA allows for tech transfer in less than 6 months
12:00 pm Panel Discussion – A New Age of GMP-Manufacturing for Future mRNA Therapies
Synopsis
The development and manufacturing of mRNA for use as vaccines and therapeutics have been established since emergency use authorisation of this technology for COVID-19. As more and more candidates now enter the clinic, there is a greater need to accelerate the production of mRNA to GMP standards. This discussion will delve deeper into GMP-source and level requirements to support your projects from discovery through to clinical development and fit your program requirements
- Developing methods to ensure sufficiency of reagents, solvents, enzymes, and nucleic acids at GMP level
- Exploring the complexities around decision making and criterion for GMP compliant products
- How to achieve a gold standard with next generation GMP-compliant technology, accuracy and reliability for mRNA constructs and clinical phases?
12:30 pm Networking Lunch Break
Reimagining the Future of mRNA Drug Process Development with Innovations to Meet Global Demands
Afternoon Chair
1:30 pm mRNA Hub Technology Transfer Program: A Cost-Effective Platform for mRNA Vaccine Innovation in LMICs?
Synopsis
- Sharing the essential elements of an mRNA vaccine design, development and production platform geared to enable LIMCs to produce mRNA products
- Discuss and outline the key challenges and learnings in establishing a “green fields” mRNA end to end commercial production process
- Discuss product innovations for effective, affordable and accessible mRNA vaccines suitable for LMICs and its relevance to pandemic preparedness
2:00 pm Effects of Single-Use Pumping Technologies on LNP Quality Attributes during mRNA Manufacturing TFF Operations
Synopsis
- Process stream characterization needs to include the impact of SU pumping technologies on LNP quality attributes
- SU Pump technology selection can impact integrity, size and mRNA encapsulation in LNPs
- Practical testing can broaden the equipment options for all unit operations used in mRNA-based manufacturing operations
2:30 pm Achieving a Successful Route to Equitable Global mRNA Drug Substance Process Development
Synopsis
- Custom good analysis for producing mRNA at different scales
- Resource and supply requirements for mass-producing mRNA for global LMIC endemic and pandemic demand
- Sustainable model for LMIC market
3:00 pm Afternoon Networking Break
3:30 pm mRNA Process Development and Manufacturing at Curia
Synopsis
- mRNA Process Development
- mRNA Drug Substance Manufacturing
- mRNA Drug Product Manufacturing
3:40 pm mRNA Without Borders: Throughput, Innovation, Scaling
Synopsis
- Influence of mRNA design on manufacturability
- Robust mRNA manufacturing platform: Challenges and perspectives
- State-of-the-art process development for throughput and scalability
4:10 pm Round Table Discussion – Clinical Trials to Global Development: Challenges of Large-Scale Process Manufacturing
Synopsis
- How to scale up early phase clinical trials to transition into development of global scale mass production of mRNA-based vaccines and therapeutics
- Emerging technologies to provide the capabilities of scaling up methods beyond the clinic
- How do you make the changes that you need to accommodate the scale along the way with practicality, troubleshooting and batch-to-batch reproducibility?
5:00 pm Biofoundry-in-a-Box: Modular Microfactories for Powering the Rapid & On-Demand Global mRNA Production
Synopsis
- Compacting and modularizing mRNA product manufacture through intensification technologies for rapid and on-demand deployment and manufacture
- Overcoming mRNA substance manufacturing hurdles with innovative technologies
- Evaluating the opportunity of smart manufacturing to transform manufacturing methods towards commercialization