8:00 am
Morning Coffee & Registration
Unlocking Opportunities & Challenges with Viral Vector Downstream Processing
8:50 am Chair’s Opening Remarks
9:00 am
Fireside Chat: Developing a Guide for Robust Viral Vector Process Development
Moderated by: Itzcoatl Pla
Synopsis
- Delivering properly defined CQAs to ensure the quality of the final product
- Bringing process modeling into the viral vector field to enhance the robustness and reliability of the manufacturing process
- Adopting automation and digitization in viral vector process control: Are we there yet?
9:45 am Commercializing Cell & Gene Therapies – the Lonza Approach for Robust Process & Analytics
Synopsis
- Developing solutions for scalable, robust and automated manufacturing of viral gene therapeutics
- Overview of Lonza’s platform technologies
- Lonza’s approach to de-risk, develop and industrialize your process
10:15 am What’s in Your Capsids? Review of analytical weapons allowing the Characterization of Empty, Full & Partial Capsids
Synopsis
- What’s a full/empty capsid?
- What are the current technologies: pros/cons
- Focusing on the current hot topics: data interpretation and specification setting
10:45 am
Structured Networking & Morning Coffee
Synopsis
This session is the perfect opportunity to get face-to-face time with the key
opinion leaders in viral vector process development & manufacturing.
Establish meaningful business relationships to build upon for the rest of the
conference and gain individual insight into the pioneering work ongoing.
11:30 am Optimized AEX Buffer Formulations for AAV Full Capsid Enrichment
Synopsis
- Identifying key factors that affect full/empty separation using AEX chromatography through an extensive DOE with multiple parameters (pH, elution salt, excipients, surfactants, stabilizers)
- Establishing serotype-dependent optimized buffer formulations using this DOE approach
- Confirming biological activity by employing a novel cell-based assay monitoring RNAtranscription
of full capsids
11:45 am Reimagining Strategies to Accelerate AAV productivity
Synopsis
- Leveraging small molecule enhancers to ramp up AAV Production
- Utilizing a QbD by DOE approach to optimize production parameters
12:15 pm Increasing AAV Process Productivity while Ensuring Scalability
Synopsis
- Increasing the purification process scale to manage >1E15 vg/L bioreactor productivity
- Establishing extensive platform design space to enable straightforward and linear scale-up
- Leveraging platform to allow for successful multi-product manufacturing
12:30 pm
Networking Lunch Break
1:30 pm Roundtable Discussion: Determining a Pragmatic Approach to Improving the Downstream Purification of Viral Vectors
Synopsis
- Exploring the most commonly used purification methods for viral gene therapy vectors
- Comparing chromatography and non-chromatography approaches and their impact on yield and product purity
- How can you decrease the number of required steps for downstream purification to maximise purity while minimising cost?
Optimizing Your Process Development for Viral Vector to Achieve Economics at Scale
2:00 pm Improvements of Purification Recovery & Productivity Using Column-Free Continuous Purification of Gene Therapy Products Via Continuous Countercurrent Tangential Chromatography (CCTC)
Synopsis
- 1st generation column based purification is not well suited for gene therapy production because of product size, fragility and specific purification challenges
- Higher recovery and scale up challenges are significant drivers for the industry
- New column-free modality (CCTC) is breaking new ground as a fully closed, fully continuous platform that decreases residence time, runs at steady-state and saves resin volume
2:15 pm Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing Demand For these Viral Vector Delivery Systems
Synopsis
- Addressing the scale up of difficult cell lines and cultures
- How do you scale up to meet clinical demands?
- Optimizing the drug product formulation to meet stability requirements at scale
2:45 pm
Afternoon Refreshments
3:15 pm Developing a Next-Generation LVV Purification Process with Improvements to Product Purity, Cost of Goods, & Regulatory Risk Mitigation
Synopsis
- Improving impurity reduction performance through development of a next-generation capture chromatography step
- Eliminating the use of animal derived raw materials and components from the process
- Maintaining consistent infectious titer yield throughout LVV purification
3:45 pm Developing an Intensified AAV Production Process to Reduce CoGs
Synopsis
- Implementing perfusion for AAV production to increase cell density and achieve high volumetric AAV yield
- Achieving significant CoGs reduction to support clinical and commercial
manufacturing targets
4:15 pm Chair’s Closing Remarks & End of Day One
4:30 pm Drinks Reception & Poster Session
Synopsis
Connect with your peers over a drink in a relaxed atmosphere to continue forging and growing your new relationships.