Explore the Agenda
8:55 am Chair’s Opening Remarks
Implementing Stable Producer & Packaging Cell Line Strategies to Reduce Manufacturing Complexity & Improve Process Robustness
9:00 am Evolving AAV Manufacturing: Comparing Transient Transfection & Producer Cell Line Platforms to Enable Scalable Gene Therapy Production
- Managing transient transfection variability at scale to improve manufacturing consistency, reduce operational complexity and support reliable pipeline delivery
- Comparing transient transfection and producer cell line platforms to inform technology selection decisions based on technical, operational and economic requirements
- Optimizing producer cell line clone selection workflows through scale-down screening models to accelerate high-performing clone identification and process development
9:30 am Improving Triple Transfection Consistency to Reduce Batch-to-Batch Variability & Minimize Manufacturing Risk
- Addressing transfection cocktail stability challenges and time-sensitive nature of plasmid-reagent complexation, preventing the batch failures that waste resources and delay clinical supply
- Optimizing mixing and pumping parameters to ensure uniform delivery of transfection complexes to cells, achieving consistent yields and quality attributes that support reliable manufacturing
- Implementing quality measurements of transfection cocktails before use to predict and prevent batch failures, reducing the costly losses that occur when transfection variability impacts downstream performance
10:00 am Morning Refreshment Break & Networking
Scaling Viral Vector Manufacturing Processes to Maintain Product Quality & Ensure Clinical & Commercial Readiness
11:00 am Panel Discussion: Establishing Risk-Based Process Development Decision Frameworks to Accelerate Clinical Progression
- Defining fit-for-purpose process performance criteria to accelerate clinical progression while maintaining robust, reliable and reproducible viral vector manufacturing
- Assessing technology adoption and supplier diversification strategies to reduce operational risk while maximizing value from established manufacturing platforms
- Balancing process optimization efforts against program timelines, manufacturing costs and patient demand to enable data-driven development decisions
11:45 am Showcasing Insect Cell-Based AAV Manufacturing Capabilities to Enable Scalable Clinical & Commercial Production
- Demonstrating an insect cell-based AAV production platform with proven process development strategies to achieve robust clinical manufacturing readiness
- Presenting a 1,000L clinical manufacturing case study with regulatory-approved quality outcomes to validate large-scale production performance
- Leveraging scalable 1,000L AAV manufacturing capabilities for neurodegenerative therapies to support broader patient access efficiently
12:15 pm Leveraging Platform & Prior Knowledge for Accelerated PPQ Campaign & Commercial Readiness Under Compressed CMC Timelines
- Establishing risk-based process characterization strategies using platform knowledge to accelerate development activities without compromising regulatory expectations
- Implementing streamlined PPQ planning and execution approaches to achieve manufacturing readiness despite limited time, historical data and resources
- Applying platform-derived control strategies to strengthen regulatory submissions, expedite CMC preparedness and support successful product approval
12:45 pm Lunch Break & Networking
Strengthening Sponsor-CDMO Tech Transfer Alignment to Accelerate Manufacturing Readiness & Clinical Timelines
1:45 pm Roundtable Discussion: Overcoming Tech Transfer Bottlenecks Through Better Sponsor-CDMO Collaboration to Accelerate Manufacturing Readiness
- Identifying documentation gaps, batch record deficiencies and training challenges to improve first-time-right tech transfer execution
- Strengthening sponsor-CDMO communication practices to reduce transfer failures, rework cycles and manufacturing delays
- Benchmarking successful transfer approaches and lessons learned from failures to accelerate clinical timelines and patient access
Optimizing Upstream Production Platforms & Downstream Purification Strategies to Reduce Viral Vector Manufacturing Costs
2:45 pm Implementing Packaging & Producer Cell Lines to Eliminate Plasmid Transfection Complexity & Reduce Manufacturing Costs
- Evaluating stable producer cell lines as alternatives to transient transfection for simplified GMP manufacturing, eliminating the expensive plasmid costs and transfection variability that drive up manufacturing expenses
- Assessing quality comparisons between transient transfection and stable cell line-derived vectors, ensuring product comparability and regulatory acceptability when transitioning platforms
- Understanding cost-benefit analysis including development timelines, productivity and regulatory considerations, making informed decisions on when producer cell line investment delivers meaningful return
3:15 pm Optimizing Anion Exchange Chromatography Strategies to Enhance AAV Empty-Full Capsid Separation Efficiency
- Establishing anion exchange chromatography as a critical purification strategy to maximize empty-full capsid separation across AAV manufacturing processes
- Comparing multiple anion exchange chromatography approaches to select the most effective strategy for specific AAV process requirements
- Aligning anion exchange method selection with serotype characteristics, impurity load and partial capsid distribution to improve purification performance