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

  • Rekha Iyengar Senior Process Development Scientist - Upstream Vector Development, Stanford University


  • 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

  • Sheldon Mink Associate Director Viral Production Core, Regeneron


  • 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


  • 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


  • 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


  • 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

  • Ashish Saksule Principal Scientist Vector Core Lead, Vertex Pharmaceuticals


  • 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


  • 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

  • Sha Sha Senior Scientist Upstream Process Development, Ultragenyx


  • Wild type VS engineered capsids
  • Serotype-specific modifications
  • Shear considerations when assessing your growth media

1:30 pm Selecting The Right Partners

  • Nitin Garg Senior Director Process Development & CMC Gene Therapy, Independent Industry Expert


  • 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

  • Ashish Saksule Principal Scientist Vector Core Lead, Vertex Pharmaceuticals


  • 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


  • 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

  • Chris Canova Chemical Engineering PhD, Massachusetts Institute of Technology


  • 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

Download the Full Event Guide for More information on:

•  20+ Expert Speaker Faculty

•  Interactive Workshops

•  6+ Hours of Dedicated Networking Breaks

•  & Much More!

Viral Vector Process Development & Manufacturing Summit - Full Event Guide