8:00 am Morning Coffee & Registration
8:50 am Chairs Opening Remarks
Optimizing Raw Materials to Improve mRNA Yield, Quality & Reduce Cost for Future-Proofing Regulatory Success at Scale
9:00 am Bridging the Innovation Gap: Characterizing New Materials & Translating mRNA Platform Advances into GMP-Ready Processes
Synopsis
- How to transfer new modalities (sequence, cap, and LNP) and innovations from R&D into robust CMC frameworks
- Building phase-appropriate control strategies in collaboration with MSAT to support robust, scalable manufacturing
- Characterizing new materials and processes to justify parameters for regulatory submissions
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9:30 am CMC, from pDNA and mRNA to LNP with Multiple Nucleic Acids Payloads
Synopsis
- The mRNA/pDNA/LNP production process involves four steps: 1) expression and purification of plasmid DNA (pDNA, minicircle DNA) in E.coli or synthetic production, followed by linearization for mRNA synthesis, 2) in-vitro transcription (IVT), 3) mRNA purification, and 4) nucleic acid encapsulation and LNP purification. Each step must meet cGMP criteria, ensure batch consistency, and be well characterized
- LNPs with multiple payloads are very sheer sensitive, therefore the TFF purification should be replaced with CIM monolith column chromatography deprived of shear forces
- LNPs with multiple payloads are very heterogenous, chromatography approach is required to purify the product and secure the robustness of the batch-to-batch product consistency
- To enable the batch-to-batch product manufacturing consistency new analytical method to characterise the LNP with multiple payloads and surface “decoration”, including the LNP stability and heterogeneity determination as well lapidated RNA amount should be used
10:00 am Enhancing Plasmid DNA Quality Through GMP Compliance, Assay Design & Poly-A Control to Improve IVT Performance
Synopsis
- How to design and apply advanced pDNA assays for conformation and residual contaminants to improve upstream process control and IVT outcomes
- Ensuring GMP-grade plasmid production aligns with evolving regulatory expectations to de-risk preclinical and clinical transitions
- Preserving and amplifying poly-A tail integrity during pDNA production to maximize IVT transcript quality and reduce downstream impurity loads
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10:30 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
11:30 am Novel mRNA Drug Product to Improve Potency
Shirisha Meda, Associate Director, BioNTech RNA Pharmaceuticals
12:00 pm Session Reserved For Syngoi
12:30 pm Tackling Stability Challenges in Self-Amplifying mRNA to Strengthen Early-Stage Development & Set the Foundation for Scale
Eric Yearley, Associate Director, samRNA Development, CSL
Track 2: IND Enabling & Clinical Scale
1:00 pm Lunch Break
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 II, Editas Medicine
2:00 pm Session Reserved For Vazyme
2:30 pm Synthetic Biology-Driven Innovation in mRNA Process Development
Diana M Posadas, Director, Strategic Research, GreenLight BioSciences
3:00 pm Session Reserved For Purilogics
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
3:40 pm Defining CQAs, QC Methods & Release Specifications to Drive Consistency & Predictability in mRNA CMC Processing
Synopsis
- Defining and linking critical quality attributes (CQAs), release specs, and control points to maintain mRNA batch consistency while improving confidence in clinical outcomes
- Evolving QC strategies beyond basic purity and identity to incorporate attributes that better predict safety, efficacy, and immunogenicity
- Ensuring alignment between internal and external teams on release expectations to support streamlined validation and global regulatory acceptance
4:10 pm Session Reserved For Aldevron
4:40 pm Streamlining Vaccine Release: Linking In Vitro Potency to In Vivo Immunogenicity for Smarter CMC Strategy
Synopsis
- Defining and measuring functional potency in line with evolving regulatory guidance and use it as a surrogate for in vivo immunogenicity.
- Identifying and prioritizing critical quality attributes (CQAs) that drive potency and simplify your final release testing panel.
- How to design an efficient comparability strategy that reduces analytical burden without compromising on consistency or regulatory expectations.
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