Main Conference: September 23-25, 2026 | Boston, MA
Gene Therapy Manufacturing & Analytics
Optimizing gene therapy manufacturing with scalable, cost-effective strategies for enhanced efficiency, quality, and patient access.
End-to-End AAV Manufacturing: Upstream, Downstream & Analytics
The Gene Therapy Manufacturing track is a 2-day roadmap to scaling AAV production with cost-effective strategies that enhance efficiency, quality, and patient access across rare and common diseases. This program delivers actionable insights on optimizing cell line development, upstream processing, capsid recovery, and downstream purification to drive maximum yield and purity. Master the regulatory pathway from R&D to BLA approval while leveraging cutting-edge analytics for product and process characterization that guarantee consistency, reliability, and long-term manufacturing excellence.
Session Spotlight: Pioneering Gene Therapy Manufacturing
Cost Reduction Innovations: Identifying critical strategies to lower production costs while maintaining high standards in gene therapy manufacturing.
- Driving Down CoGs: Exploring transformative advancements in process optimization, automation, AI and scaling to reduce costs without compromising quality.
- Smart Scaling: Balancing speed, cost, and quality to achieve efficient and scalable manufacturing solutions.
- Best Practices in Manufacturing: Practical approaches to enhance efficiency and reduce CoGs in gene therapy production.
- Securing the Supply Chain: Mitigating risks in raw materials and critical components.
- Cost Effective Scaling from Rare to Common Diseases: Overcoming unique challenges in manufacturing for larger patient populations
Keynote Panel Discussion: Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
Thursday, September 24, 2026 9:00 AM
Craig Malzahn, EVP, Product Development and Chief Technology Officer, Regenxbio
Phillip Ramsey, CTO, SVP Technical Operations, Sangamo Therapeutics
Kumar Dhanasekharan, PhD, President and CEO, Gokyo Biosciences Inc.
Jared Simons, VP, Manufacturing, Solid Biosciences Inc.
Keenan Bashour, VP, Manufacturing & Process Development, 4D Molecular Therapeutics
Track Themes: A Blueprint for Gene Therapy Excellence
Cell Line and Upstream Processing Advances
Explore cutting-edge cell line engineering and cell culture innovations and real-world case studies demonstrating how advanced producer cell lines and leveraging systems biology and modelling can increase yields, reduce transfection costs, and enable scalable, cost-effective large-scale gene therapy manufacturing.
Optimizing Downstream Processing for Higher Yields
Discover innovative downstream processing strategies, from high-throughput development and full capsid enrichment to scalable purification methods, that maximize AAV recovery, remove impurities, and overcome clarification challenges for higher-quality yields.
Effective Tech Transfers
Gain insights into proven and evolving strategies for seamlessly transferring gene therapy manufacturing processes to CDMO partners, ensuring robust collaboration, process alignment, and optimized outcomes from clinical to commercial scale.
Fast-Track BLA Approvals
Learn from recent approvals and late-stage products how to meet FDA expectations, build robust commercial release packages, avoid CMC delays, and develop winning strategies for successful BLA filing and gene therapy approval.