7:15 am Registration & Morning Networking Coffee

8:05 am Chair’s Opening Remarks

  • Rachit Jain Director – Process Development, Tessera Therapeutics

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

  • Elaine Peters Director – Cell & Gene Therapy Analytical Capabilities, Genentech

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

  • Hunter Stitik Director - Enterprise Science & Innovation, ThermoFisher Scientific

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

  • Jin Zhou Executive Director - Process Development; mRNA & Protein Biologics, Ultragenyx Pharmaceutical

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

  • Serena Smith Director - Strategy & Market Intelligence, Thermo Fisher Scientific
  • Martin Carvalho Head – Quality, mRNA Centre of Excellence, Sanofi
  • Srinivasulu Bandi Director - BioProcess Development, Senda Biosciences
  • Jin Zhou Executive Director - Process Development; mRNA & Protein Biologics, Ultragenyx Pharmaceutical

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

  • Vijay Dhawan Head – Analytical Development/QC, Genomic Medicine, Sanofi

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

  • Rachit Jain Director – Process Development, Tessera Therapeutics

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

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

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

5:30 pm Chair’s Closing Remarks & End of Conference Day One

  • Vijay Dhawan Head – Analytical Development/QC, Genomic Medicine, Sanofi

5:45 pm Poster Session & Drinks Reception

End of Conference Day 1