7:30 am Morning Coffee & Registration
8:20 am Chairs Opening Remarks
Optimizing Raw Materials to Improve mRNA Yield, Quality & Reduce Cost for Future-Proofing Regulatory Success at Scale
8:30 am Accelerating the Path from Innovation to Implementation
9:00 am CMC, from pDNA and mRNA to LNP with Multiple Nucleic Acids Payloads
9:30 am Fireside Chat: Enhancing Plasmid DNA Quality Through GMP Compliance, Assay Design & Poly-A Control to Improve IVT Performance
10:00 am Morning Break & Speed Networking
Synopsis
Our dedicated speed networking session is the perfect opportunity to have in-depth conversations and forge long-lasting connections with fellow technical experts working within mRNA process development & CMC.
Track 1: Research Scale
Optimizing Process Development for Emerging mRNA Modalities to Expand Indication Reach & Maximize Therapeutic Performance
11:00 am Novel mRNA Drug Product to Improve Potency
Shirisha Meda, Associate Director, BioNTech
11:30 am Improving mRNA Manufacturing and Delivery Timelines Using Optimized Synthetic Linear DNA from Pure Synthetic DNA
Julen Oyarzabal, Chief Scientific Officer & Founder, SYNGOI SLU
12:00 pm Tackling Stability Challenges in Self-Amplifying mRNA to Strengthen Early-Stage Development & Set the Foundation for Scale
Eric Yearley, Associate Director - Messenger Ribonucleic Acid & Analytical Development, CSL
Track 2: IND Enabling & Clinical Scale
12:30 pm Lunch Break
12:30 pm Chromatan Sponsored Lunch
Synopsis
Steady-state Continuous Purification of mRNA with fully integrated PAT for improved recovery and product quality to enable next generation mRNA manufacturing facility
Track 1: Research Scale
Strengthening Manufacturing to Overcome Gene Editing Therapeutic Bottlenecks & Advance Production
1:30 pm Guiding mRNA Format Selection with Analytical Strategies to Match Modality-Specific Needs in Gene Editing
Linnea Jansson-Fritzberg, Scientist, Editas Medicine
2:00 pm Innovation in Assays and Enzymes of RNA Therapeutics Development
May Guo, CSO, Vazyme
2:30 pm Synthetic Biology-Driven Innovation in mRNA Process Development
Diana Posadas, director, GreenLight BioSciences
3:00 pm Unlocking the “True” Potential of Membrane-Based Chromatography – Solutions for the Next Generation of mRNA Manufacturing
Track 2: IND Enabling & Clinical Scale
3:10 pm Afternoon Break & Poster Presentations
Synopsis
Contribute to the conversation and share your cutting-edge research with like-minded mRNA experts. To present a poster, register your place and submit an abstract highlighting your breakthrough discovery. *Please visit the website for T&Cs for presenting a poster
Building Robust CMC Processes that Enable Scalable, Phase-Ready mRNA Development to Accelerate Clinical Advancement with Confidence
4:00 pm Defining CQAs, QC Methods & Release Specifications to Drive Consistency & Predictability in mRNA CMC Processing
4:30 pm Trade-offs between yield and full-length product in RNA manufacturing
Synopsis
- Although an mRNA QC panel has many components, yield and percent full-length product (FLP) cut to the heart of costs and purity.
- The direction of the correlation between yield and FLP can change with study scale (i.e., within vs between constructs, range of tested conditions), but there is strong theoretical and empirical evidence that these two values commonly trade-off against each other.
- Variables to consider when process developing to optimize an mRNA manufacturing process for maximum quantity without compromising quality.