Conference Day One - Wednesday, September 18
7.30 Check In & Morning Coffee
8.20 Chair’s Opening Remarks
Accelerating mRNA Process Development Through Platform-Level Advancement to Expedite Drug Manufacturing
8.30 Platform-Based Approaches to Streamline mRNA Drug Substance Process Development & Validation
9.00 mRNA-LNP Manufacturing Platform
9.30 Panel Discussion: Planning for the Future of mRNA Drugs: How Can CMC Platforms Support the Next Wave of Approvals in the mRNA Field?
10.00 Morning Break & Speed Networking
Research Scale Track
Chair: Nicole Eschmann, Principal Scientist – Bioprocess R&D, Pfizer
Overcoming Bottlenecks with IVT Reactions for Faster Scale Up While Maintaining mRNA Yield & Quality
11.00 Addressing Purification Challenges Resulting from Scale Up of Design of Experiments (DOE) Optimized IVT Reactions
11.30 Optimized Synthetic DNA: Speeding Up Delivery Times & Improving mRNA Quantity & Quality
12.00 Optimizing IVT Reactions to Effectively Scale-Up mRNA Production from Research to Pre-Clinical Scale & Beyond
12.30 Overcoming Pump Tube Limitations in Demanding mRNA Manufacturing Steps
IND-Enabling & Clinical Scale Track>
Chair: Babak Sanii, Associate Director Biochip R&D, Nutcracker Therapeutics
Chair: Babak Sanii, Associate Director Biochip R&D, Nutcracker Therapeutics
Highlighting Process Analytical Technologies (PATs) to Predict & Control mRNA Quality, Stability & Potency
11.00 Spotlighting a Novel Fluidics Approach to the Manufacturing of RNA That is Fully Pure at the Outset & Implementing a Novel On-Line Assay to Determine RNA Quality
11.30 Innovative Cap Analog Design for Enhanced mRNA Immune Evasion
12.00 Outlining Analytical & Potency Assays for RNA Product Predictability of Efficacy for Multivalent Drug Products
12.30 More Samples & Faster Turnaround Measuring Capped mRNA Integrity & 5’ Capping Efficiency
12.40 Lunch Break & Networking
Enhancing Next Generation mRNA Process Development to Accelerate the Production of Novel Modalities
1.40 Overcome dsRNA Challenge: Innovation in Assays & Enzymes
2.10 Early-Stage mRNA Development: Key Considerations for Establishing Robust Processes for Novel Modalities like circRNA
Getting a Fast Start into the Clinic: Tackling Bottlenecks While Scaling Up mRNA Drug Product Manufacturing
1.40 LNP Process Characterization & Optimization for Phase III Readiness for a Personalized Cancer Therapy
2.10 Maintaining High Yield & Drug Product Quality to Confidently Accelerate your mRNA Candidate into the Clinic
2.40 Afternoon Networking Break & Poster Session
Approaching mRNA Process Development & Manufacturing Bottlenecks for Gene Editing Therapeutics to Achieve High Quality mRNA for Enhanced Editing Efficiency
3.40 Fireside Chat: Spotlighting mRNA Manufacturing Considerations Specific to Gene Editing Therapeutics
4.10 Innovative RNA Manufacturing: Breaking Barriers with Mutant T7 Polymerase
Synopsis
- Leverage our experience advancing cell and gene therapies with tailored manufacturing solutions supporting your development and commercialization goals
- Explore our innovative capabilities for diverse production needs, from preclinical to commercial-scale manufacturing
- Benefit from our integrated approach to a single-source manufacturing solution encompassing DNA, mRNA, LNP, and process enzymes