Explore the Agenda
8:55 am Chair’s Opening Remarks
Building Platform-Ready Viral Vector Manufacturing Processes to Increase Vector Productivity & Regulatory Confidence
9:00 am Scalable Novel Engineered Capsids: From Platform Manufacturability to First-in-Human
- Demonstrating that a novel engineered capsid can be manufactured on existing platform processes with productivities and yields comparable to AAV9 and confirmed at 500L clinical scale
- Building the capsid access and tech transfer infrastructure that lets partners move quickly: established master cell banks and rep-cap plasmid at CDMOs, plus low-friction material transfer pathways for academic, foundation, and industry programs
- Constructing an FDA-informed, MOA-driven CMC and preclinical package for a human receptor-targeted capsid to support regulatory filings and first-in-human dosing
9:30 am Harnessing Integrated DOE Strategies Across Upstream & Downstream Development to Maximize AAV Productivity
- Implementing carefully designed DOE studies during transfection development to increase AAV productivity while maintaining process robustness
- Incorporating full-to-empty capsid ratio considerations during upstream optimization to simplify downstream purification and improve product quality
- Connecting upstream process decisions with downstream empty/full separation strategies to increase development success and overall manufacturing efficiency
10:00 am Fireside Chat: Leveraging FDA Platform Technology Designation Program Learnings to Accelerate Multi-Program Development & Reduce Redundant Studies
- Understanding regulatory interactions and data package requirements for platform designation applications, positioning companies to benefit from streamlined review processes and reduced filing burdens
- Sharing knowledge from companies that have successfully obtained platform designation to reduce redundant development, saving years of process characterization work and millions in development costs
- Navigating applicability of platform approaches for small companies with single assets versus large multi-program portfolios, determining when platform investment delivers meaningful return
10:45 am Speed Networking
Building robust, scalable, and cost-effective viral vector manufacturing processes cannot be solved in silos. This structured networking session gives you the opportunity to connect with peers, exchange ideas, benchmark strategies, and build relationships with the leaders advancing viral vector manufacturing
11:15 am Morning Refreshment Break
Leveraging Viral Vector Platform Processes to Accelerate Development & Reduce CMC Burden
11:45 am Partnering With Established Viral Vector Manufacturing Platforms to Accelerate PPQ Readiness & Reduce Commercialization Risk
- Partnering with experienced viral vector CDMOs to accelerate commercialization readiness through proven manufacturing expertise and regulatory support
- Leveraging established platform knowledge to streamline process characterization activities and reduce validation timelines, costs, and resource burden
- Utilizing manufacturing experience and historical data to strengthen regulatory responses and demonstrate consistent PPQ performance
12:15 pm Session Details to be Announced
- Presented by LONZA
12:45 pm Lunch Break & Networking
Developing Robust Vector Purification Platforms to Improve Yield, Purity & Scalability
1:45 pm Advancing Empty/Full Capsid Separation Technologies to Increase Potent Product Yield & Minimize Manufacturing Costs
- Evaluating novel chromatography resins and purification modalities to improve separation of genome containing versus non-genome-containing capsids, reducing the significant product losses that drive up cost per dose
- Implementing emerging analytical technologies including mass photometry, nanomosaic and analytical ultracentrifugation (AUC) for enhanced empty/full characterization to support regulatory filing confidence and process optimization
- Optimizing purification strategies to achieve higher purity levels while maintaining acceptable recovery rates and infectious titer, delivering more doses per batch for improved patient access
2:15 pm Session Details to be Announced
- Presented by Boston BioProducts
2:25 pm Poster Session & Afternoon Break
Explore the latest viral vector manufacturing innovations and practical case studies in this interactive poster session, showcasing approaches to improve productivity, strengthen process robustness, optimize purification, and accelerate scalable AAV, LVV and more novel viral vector production.
Reducing Viral Vector Development & Manufacturing Costs to Enable Sustainable Clinical Commercialization
3:30 pm Minimizing Chemistry, Manufacturing & Controls (CMC) Burden for Rare & Ultra-Rare Disease Programs to Enable Small Company Success
- Streamlining validation package requirements and Process Performance Qualification (PPQ) batch strategies to reduce multi-million-dollar costs that threaten program viability for single-asset developers
- Balancing regulatory compliance with practical cost constraints for small companies, implementing efficient approaches that meet agency standards without excessive financial burden
- Implementing efficient process development strategies that achieve regulatory approval while preserving capital for clinical trials and commercial launch preparation
4:00 pm Increasing Productivity as the Root Cause Solution to Cost Challenges & Long-Term Market Viability
- Improving upstream yields and downstream recoveries to generate more doses per batch and dramatically reduce cost per dose, making therapies accessible to broader patient populations
- Comparing cost of goods across industry to establish benchmarks and identify improvement opportunities, leveraging best practices to accelerate cost reduction initiatives
- Ensuring business sustainability by bringing manufacturing costs down to accessible price points, enabling reimbursement approval and global market expansion