8:30 am
Morning Coffee
Optimizing Upstream Processes to Enhance Scalable Viral Vector Manufacturing
9:20 am Chair’s Opening Remarks
9:30 am Developing Baculovirus Expression Vectors to Decrease Time to IND Filing
Synopsis
- Introducing challenges associated with baculovirus expression vector development
- Identifying strategies to address lengthened development times
- Uncovering proof of concept data supporting how the identified strategies can improve development time and stability
10:00 am Process Development & Scale Up Of rAVVs Processes: Opportunities for Acceleration & Cost Reduction
Synopsis
- 400x scale up of the rAAV production process: lessons learned and best practices
- Optimization of affinity chromatography for capsid recovery and impurity removal
- Accelerated process development/characterization through digitization and high-throughput enablement
10:15 am Panel Discussion: Comparing the Triple Transfection Process to Viral Based Production System to Ensure Quality, Scalability & Productivity
Synopsis
- Examining the advantages and disadvantages of triple transfection and viral based production systems
- Navigating the production systems in early stage versus late stage development
- How do you approach the differences in production systems in relation to systemic or localized administration?
11:00 am
Speed Networking & Morning Coffee
12:00 pm Process Development & Scale Up Of rAVVs Processes: Opportunities for Acceleration & Cost Reduction
Synopsis
- π-Alpha 293 AAV High-yield Production Platform: Improved scalability & Biosafety
- π-Omega and π-Lambda Plasmid Production Platforms: Higher Yield and Quality with Lower Cost
- Case study will be discussed with a successful scale up of a developed process from bench-scale to clinical-scale
12:15 pm Shall We Relieve the Painful rAAV Process Development & Regulatory Concerns In Advance?
Synopsis
- Selecting an idea HEK293 suspension cell line for triple transfection while considering regulatory guidance, upstream cell culture, AND downstream purification
- Introducing regulatory guidance preferred HEK293 suspension clone candidates that demonstrate zero aggregation under high-density cell culture and significantly low nutrient consumption
- Demonstrating a full spectrum cell line evaluation example to meet both upstream and downstream’s demands Meeting Regulatory Expectations, On & Below
12:45 pm
Networking Lunch Break
Meeting Regulatory Expectations, On & Below the Lines
1:45 pm Establishing Product Quality Standards for AAV Vectors to Enable Smooth Gene Therapy Regulatory Filing
Synopsis
- Highlighting the significance of holding and understanding CQAs early on to allow comparability throughout process changes and batch
- Outlining the landscape of regulatory expectations for viral vectors, such as contaminant levels of host protein, adventitious virus, and empty/full specifications
- How can you best defend your product meeting critical attributes with regulatory bodies?
2:15 pm Enabling Large-scale LV vector production to Achieve Improved Process Speed and Cost
Synopsis
- Streamlining your choice of bioreactor and upstream production platform foryour product
- How can you ensure good scalability between the full-scale and the small-scale processes?
- Highlighting critical process parameters and key steps in production that you should optimize to ascertain a successful LV vector production
At the end of the session, we will ask each group to share feedback and open up for further Q&As.