Conference Day One
Wednesday | February 21, 2024
8:00 am Registration & Welcome Coffee
8:50 am Chair’s Opening Remarks
Exploring the Landscape of Viral Vector Market: A Comprehensive Analysis of Market Trends, Regulatory Framework, & Innovative Capsid Engineering Strategies
9:00 am Audience Discussion: Best Practices In Facility Management to Enhance the Efficiency & Quality of Viral Vector Production
Synopsis
- Discussing strategies for efficient facility design to optimize operational efficiency
- Setting up a manufacturing facility, integrating automation for streamlined manufacturing processes
- Addressing regulatory requirements and maintaining high documentation standards to ensure compliance and traceability
- Establishing effective communication with quality assurance and quality control teams to enable collaboration for strong product quality
9:30 am A Paradigm Shift: Reimagining Novel Viral Vectors to Transform Development Cost Dynamics
Synopsis
- Clinical translation & exciting developments in capsid engineering
- Payload-specific capsids for AAV
- Discussing the specifics: reducing immunogenicity
10:00 am Lead Partner Presentation – Lonza
10:30 am Morning Refreshments & Speed Networking
Upstream Process Development
Chair Person: Aziza Manceur, Research Officer, NRC
Giving a Kickstart: Producer Cell Line Engineering & Manufacturability Assessments
11:30 am From The Beginning: Evaluating Critical Manufacturability Criteria
Synopsis
- Balancing biodistribution with translational outputs
- Plasmid combinations with specific genes of interest
Optimizing Transfection & Navigating the VolumeDependant Challenges Analogous to Upscaling Viral Vector
12:00 pm Cell Equilibrium: Mammalian Cell Health vs Protein Expression & Switching Culture Vessels
Synopsis
- Transitioning between culture vessels: assessment of cell stacks & hyper stacks
- Controlling host cell expression of vector proteins: overcoming the cytotoxic side-effects
- Innovations in cell culture & assessing viral safety: adventitious agents
Downstream Process Development
Sequencing the Future: Revolutionizing Upscaling with Next-Generation Strategies & Assay Design for High-Titre Compatibility
11:30 am Next Generation Sequencing Strategies to Facilitate the Upscale Process
Synopsis
- Application of NGS for improved vector integrity
- Conducting gene interest analysis
- Quantifying host cell/DNA
Enhancing your Platforms & Augmenting Recovery for Improved Product Yield
12:00 pm Route to Regulatory: Superior Platform Technologies
Synopsis
- Developing platforms: Flexibility in the DSP platform approach
- Defining your platform to accelerate the transmission of gene therapies from lab to the regulatory space
- Gene therapy & cell therapy platforms: utility design & making reoptimization redundant
12:30 pm Lunch
1:30 pm Creating an Isogenic Population: Subcloning, Plasmid Production & Transfection Techniques to Reduce Variability
Synopsis
- Subcloning amenable cells for optimal efficiency
- Uncovering the techniques used to isolate cells (Berkley Lights)
- Methods to eliminate or reduce HEK293 plasmid production costs
2:00 pm Troubleshooting, Modifying & Optimizing Formulation for Improved Vector Behavior
Synopsis
- Wild type VS engineered capsids
- Serotype-specific modifications
- Shear considerations when assessing your growth media
1:30 pm Selecting The Right Partners
Synopsis
- Bridging the gap between industry, partners & academia
- Align on manufacturing process robustness vs speed for early phase programs
- Collaboration rather than competition mindset between various institutions and/or organizations
2:15 pm Innovation Partner Presentation – ChromaTan
2:30 pm Afternoon Refreshments & Poster Session
3:30 pm ROUNDTABLE: Enhancing Downstream Enrichment for AAVs & Optimizing Processes for Cost Efficiency & Scalability
Synopsis
- Addressing the critical importance of optimizing downstream manufacturing processes using technology to increase efficient production and manufacturing
- Sharing and delving into insights on how a robust scalable transfection process can enhance efficiency and cost-effectiveness
- Discussing the significance of achieving high purity and yield in AAV purification to meet regulatory standards
- Outlining practical approaches to achieve scalability in the purification and enrichment of AAVs and how this contributes to cost reduction
4:15 pm Standardized Full Capsid Enrichment and PCR Sample Preparation Platforms for AAV Process Development
Synopsis
- Outlining the need for standardization in the manufacturing of AAV gene therapies to ensure reproducible and scalable processes
- Demonstrating two products to provide a platform solution for critical steps within the AAV workflow
- Presenting a serotype specific AEX buffer screening kit to facilitate quick and scalable identification of the optimal equilibration and elution formulation needed for high recovery and purity
- Illustrating a standardized AAV sample preparation platform for use in PCR applications that demonstrates robustness across serotypes and steps within the manufacturing workflow
4:45 pm Upscaling Transfection: Overcoming the Challenges Analogous to Increasing Transfection Volume with Increasing Bioreactors
Synopsis
- Extending the window of transfection complex formation: evaluating affinity resins
- Evaluating transfection reagents with improved stability over extended periods
5:15 pm Chair’s Closing remarks
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• 20+ Expert Speaker Faculty
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