Pre-Conference Workshop Day

Tuesday, September 20

Workshop A

9:00 - 12:00

Defining mRNA Drug Substance Quality Control Attributes for mRNA Drug Product

mRNA technology now enables rapid development of vaccines and novel therapeutics. Likewise, quality control and assurance for manufacturing processes and lot release of mRNA are undergoing accelerated evolution. This workshop aims to determine strategies and methods for mRNA quality control and provide a better understanding of the quality requirements for process monitoring and lot release of mRNA-based vaccine and therapeutic products.

  • What are key quality attributes and decisions for mRNA drug substance process?
  • How to better understand and plan for regulatory expectations in terms of drug substance quality and process?
  • How to define a quality control roadmap for effective process scale up and manufacturing?

Workshop Leader:

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Emily English
Senior Director – Quality
Cartesian Therapeutics

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Camilla Foged
Professor – Vaccine Design & Delivery
University of Copenhagen

Workshop B

1:00 - 4:00

Addressing Regulatory Perspectives on Requirements for Effective mRNA Process Scale Up

With increasing investment in mRNA technology platforms and robust regulatory-specific frameworks for mRNA drug substance and product quality, it is now critical to streamline processes and provide greater clarity and guidance for this developing industry. This workshop aims to define the increasing requirements for processes development, methods for regulatory submission pathway and expected quality attributes

  • How to successfully streamline the development of mRNA process development to ensure rapid and effective approval?
  • How to identify the key regulatory bottlenecks from early development to clinical translation for process scale-up?

Workshop Leaders:

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Philippe Alexandre Gilbert
Senior Program Officer - CMC
Bill & Melinda Gates Foundation

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