8:00 am Morning Coffee & Registration
Bridging the Gap to Purification Prevention: Advancing Upstream Process Execution to Ensure RNA Purity from the Outset & Eliminate the Need for Purification
9:00 am Reviewing the Relationship between DNA Starting Materials & IVT Fidelity to Build RNA Purity From the Beginning
Synopsis
- Comparing plasmid, enzymatic, dbDNA, and synthetic DNA templates to assess their impact on IVT yield, fidelity, and dsRNA formation risk
- Defining template-specific quality attributes and impurity thresholds to improve process consistency and regulatory readiness
- How to strategically select and qualify DNA starting materials to reduce downstream purification burden and accelerate development timelines
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9:30 am Roundtable Discussion: Defining Upstream Material Specs in Line with Analytics to Minimize Impurity Risk and Strengthen Process Control
Synopsis
- How can early-phase analytics predict downstream impurity risk and inform pDNA acceptance criteria
- What QC tests are essential to ensure pDNA and buffer inputs meet process needs without triggering unexpected impurity profiles in the IVT
- Imbedding early standardization of raw material specifications to support regulatory alignment and tech transfer
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10:30 am A Roadmap to Better Designer Polymerase Enzymes: Decoding IVT Reaction Kinetics to Define Optimal Mutant Polymerases That Minimize DSRNA Formation & Preserve Yield
Synopsis
- Defining the characteristics of ideal mutant polymerases that balance high fidelity and reduced dsRNA formation for superior IVT performance
- Applying kinetic modeling and enzyme behavior analysis to identify polymerases best suited for different IVT systems, template types, and sequence lengths
- Using data-driven approaches and mechanistic insights to guide the design and discovery of next-generation polymerases for enhanced IVT efficiency and purity
11:00 am Morning Break
Evaluating Novel Purification Methods to Reduce Number of Downstream Steps & Build More Robust & Reproducible Purification Processes at Scale
12:00 pm Optimizing Next-Gen Membrane-Based affinity Purification to Enhance Resolution & Reduce Process Complexity
Synopsis
- What role do membrane-based materials play in improving separation of dsRNA, enzymes, and truncated products
- How can media performance be benchmarked under variable loads, flow rates, and buffer conditions to ensure robustness
- How are new purification materials helping reduce process footprint, buffer volumes, and COGs
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12:30 pm Roundtable Discussion: Selecting the Right Capture Method: Comparing Resin Based, HIC & Affinity Techniques Across Modalities
Synopsis
- Evaluating resin based, HIC, and affinity capture strategies to meet diverse modality needs while maximizing mRNA recovery and resolution
- What are the pros and cons of each platform for assessing transcript integrity, residual DNA, and impurities
- Applying real-world learnings from circular and self-amplifying RNA programs to improve platform purification decisions
- Balancing modality complexity with platform standardization to reduce development time and streamline scale-up
1:30 pm Lunch Break
Advancing dsRNA Removal Strategies to Improve Purity, Reduce Immunogenicity, & Meet Regulatory Expectations
2:30 pm Implementing Layered Control Strategies to Mitigate dsRNA Production & Downstream Processing
Synopsis
- Mapping dsRNA generation risk points across IVT and purification to implement control points that reduce immunogenic impurity formation
- Characterizing and differentiate between critical impurities such as dsRNA, truncated transcripts, uncapped RNA to prioritize control strategies that safeguard clinical success and efficacy
- Tailoring dsRNA specifications based on modality and dose sensitivity to ensure impurity limits are appropriate for vaccines versus more sensitive IV therapeutics, supporting both safety and regulatory success
3:00 pm Harnessing Raman Spectroscopy vs IR Spectroscopy to Improve dsRNA Detection & Strengthen In-Process Control Strategies
Synopsis
- Applying Raman spectroscopy for real-time, non-destructive detection of dsRNA during downstream purification to enable faster decision-making and reduce batch failure risk
- Integrating Raman with multivariate data analysis to differentiate dsRNA from full-length mRNA and truncated species for more precise impurity profiling
- Validating Raman spectroscopy as a GMP-compliant PAT tool to support regulatory confidence and strengthen impurity clearance claims during late-stage development
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3:30 pm Unlocking Next-Gen Sequencing for In-Process Detection of dsRNA Impurities
Synopsis
- Integrating NGS into in-process workflows to detect and quantify dsRNA impurities with high resolution and sensitivity
- Comparing NGS with traditional detection methods to improve decision-making on critical quality attributes
- Optimizing sampling points and readout strategies for real-time insight into impurity formation during IVT and purification
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