8:00 am
Morning Coffee & Registration

Unlocking Opportunities & Challenges with Viral Vector Downstream Processing

8:50 am Chair’s Opening Remarks

  • Itzcoatl Pla Head of Gene Delivery, Process and Analytical Development, Bristol Myers Squibb

9:00 am Fireside Chat: Developing a Guide for Robust Viral Vector Process Development
Moderated by: Itzcoatl Pla

  • Itzcoatl Pla Head of Gene Delivery, Process and Analytical Development, Bristol Myers Squibb
  • Anadita Seth Vice President, Process & Analytical Development, Neurogene
  • Qingwei Deng Associate Director, Analytical Development Lead, UCB


  • 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


  • 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

  • Gael Debauve Head, Gene CMC Therapy Analytics, UCB , US Pharmacopeia


  •  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


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


  • 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

  • Stephen Zano Associate Director, Early Research & Process Development, Sarepta Therapeutics


  • 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

  • Michael Mercaldi Vice President, CMC Management & Purification & Drug Product Sciences, Oxford Biomedica Solutions


  • 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

  • Ashish Saksule Principal Scientist, Vector Core Lead, Vertex Pharmaceuticals


  • 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)


  • 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

  • Seth Levy Director, Bioprocess Development, Modalis Therapeutics


  • 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

  • Adnan Kapadia Scientist, Vector Process Development, 2Seventy Bio


  • 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

  • Wei Zue Senior Scientist, Ultragenyx


  • 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

  • Itzcoatl Pla Head of Gene Delivery, Process and Analytical Development, Bristol Myers Squibb

4:30 pm Drinks Reception & Poster Session


Connect with your peers over a drink in a relaxed atmosphere to continue forging and growing your new relationships.