Streamline, Scale & Modernise End‑to‑End mRNA Production
As mRNA programmes mature, conventional batch processes and fragmented workflows create unnecessary cost, variability and delays. This stream focuses on the innovations that enable true end‑to‑end efficiency — from continuous IVT and integrated purification to automation, inline analytics and real‑time process control. With expert insights from the University of Sheffield, CEPI and CPI, you’ll discover how to design leaner, faster, digitally connected manufacturing platforms that boost consistency, reduce cost of goods and accelerate your path from development to GMP scale.
Critical Sessions Driving Scalable, Continuous mRNA Manufacturing:
11:30 am Developing a Continuous, Automated, and Digitalised End-to-End RNA Manufacturing Platform
- Designing an integrated end-to-end RNA manufacturing system combining IVT synthesis, purification, formulation, and sterile filtration
- Incorporating inline monitoring sensors for real-time feedback and process control across continuous RNA workflows
- Lessons from the Innovate UK and CEPI-funded development programs, translating research-stage automation to GMP environments
12:00 pm CEPI Playbook: Designing Continuous mRNA Manufacturing Platforms to Reduce Cost, Increase Speed & Enable Global Access
- Engineering simplified, continuous mRNA workflows that shorten process steps and reduce cost of goods while maintaining GMP-grade quality
- Integrating synthetic DNA, continuous IVT, and inline analytics to enable faster release decisions and real-time process control
- Building resilient, scalable manufacturing platforms designed for rapid deployment, technology transfer, and equitable access across global settings
1:00 pm Workshop B – Integrating IVT and Continuous Oligo-dT Purification to Enable Low- Cost, High-Quality mRNA Drug Substance Manufacturing
As mRNA drug substance manufacturing evolves beyond early clinical supply, purification is emerging as a critical lever for both cost control and product quality. Traditional batch-based IVT and downstream purification workflows introduce avoidable material losses, extended processing times, and challenges in maintaining consistency at scale. Led by the University of Sheffield, this workshop will examine how integrating IVT with continuous oligo-dT–based purification can streamline drug substance production into a single, connected operation. Attendees will gain practical insight into how capture-based purification during or immediately post-IVT supports higher purity, improved consistency, and scalable manufacturing while maintaining regulatory robustness.
- Redesigning IVT–purification workflows as a single, integrated unit operation to reduce material loss, processing time, and overall cost of goods
- Leveraging oligo-dT–based capture during or immediately post-IVT to improve mRNA purity, consistency, and removal of truncated species and impurities
- Evaluating how integrated purification strategies support continuous and scalable manufacturing without compromising drug substance quality or regulatory robustness
2:30 pm Leveraging Process Analytical Technologies to Enable Real-Time Control and Automation in mRNA Manufacturing
- Exploring strategies for implementing inline and online measurements to enable realtime mRNA process monitoring and optimization
- Lessons from CPI’s experience with PAT integration across different modalities and how these translate into mRNA workflows
- How emerging biofoundry approaches can accelerate analytical development and data-driven process design
Industry Leaders Redefining the Future of mRNA Production:
Join Europe’s end-to-end dedicated community for mRNA Process, CMC and Manufacturing excellence - where regulators, innovators, and technical leaders unite to set the benchmark for quality, cost-effectiveness, and clinical success.
Attending Companies Include