Pre-Conference Workshop Day: Tuesday, 6th May
8:30 am Registration & Morning Coffee
9:00 am Workshop A – Leveraging Biocatalysis & Enzyme Engineering: Rethinking mRNA Process Development for Scalable, Efficient & High-Quality Production
Synopsis
This interactive workshop delves into the role of biocatalysis and enzyme engineering in mRNA process development and manufacturing. Discover how precision enzyme design and optimization can overcome production and scaling bottlenecks to deliver high-quality therapeutics and vaccines for meeting global demands and regulatory expectations efficiently. By bridging theory and real-world applications, this session will provide expert insights and actionable strategies to streamline workflows, reduce costs, and improve product quality.
- How can biocatalytic approaches be leveraged to streamline mRNA production for improved reaction efficiency and reduction of cost in process development?
- How to optimise enzymatic processes in IVT to maximise performance at room temperature, yield and scalability without compromising mRNA integrity?
- How to leverage high-throughput screening methods to rapidly identify enzyme variants and mutants for improved catalytic efficiency in IVT?
- How can enzyme selection and engineering be tailored to align mRNA production with evolving EU regulatory requirements for clinical readiness?
11:00 am Morning Break & Networking
11:30 am Workshop B – Harnessing Inline Analytics for Real-Time mRNA Process Control: Driving Quality, Efficiency & Compliance for More Efficacious mRNA Drugs
Synopsis
Inline analytics act as the real-time lens into process outcomes, providing critical insights that transform mRNA manufacturing. By enabling continuous monitoring and control, these systems empower process development experts to make data-driven decisions, reduce waste, and enhance product quality. This workshop will explore the shift from offline to inline analytical methods, showcasing how they help achieve stringent quality standards, minimize variability, and accelerate regulatory approval with confidence.
- How have inline analytics evolved from traditional immuno-based assays to enable continuous and precise monitoring of mRNA quality in real time?
- How can real-time feedback systems identify and address process deviations early, reducing batch failures and optimizing resource usage?
- How does QbDD (Quality by Digital Design) integration with inline analytics enable end-to-end process simulation, improving efficiency and minimizing trial-and-error in mRNA manufacturing?
- How can inline analytics support consistent data collection to streamline regulatory documentation and facilitate faster approval processes?
1:30 pm Lunch Break & Networking
2:30 pm Workshop C – Leveraging Synthetic DNA for Faster, Scalable & Cost-Effective Solutions to Meet Scaling Manufacturing Demands
Synopsis
Synthetic DNA presents a game-changing opportunity to address challenges inherent to pDNA—such as endotoxicity, immunogenicity, and long production timelines. While it has yet to achieve widespread adoption, the time is ripe to harness its potential and revolutionise mRNA manufacturing processes. This workshop will explore how synthetic DNA can drive efficiency, scalability, and customisation in mRNA production, empowering manufacturers to meet diverse therapeutic and vaccine demands.
- How can synthetic DNA protocols be optimised to minimise error rates and reduce raw material costs while achieving yield targets with up to 50% less DNA input?
- How can synthetic DNA templates accelerate manufacturing timelines, from 9 weeks to 1 week, for continuous manufacturing and enhanced readiness for largescale and personalised demands?
- How do tailored synthetic platforms create opportunities for custom mRNA production, enabling rapid adaptation for diverse therapeutic and vaccine needs?
- What are the key barriers to adopting synthetic DNA, and how can they be overcome to accelerate mainstream implementation in mRNA manufacturing?