Main Conference: September 23-25, 2026 | Boston, MA
Cell Therapy Manufacturing & Analytics
Smarter, faster, and more cost-effective production of autologous, allogeneic, iPSC, and gene-edited therapies.
Transforming Cell Therapy Manufacturing: Innovation at Scale
The Cell Therapy Manufacturing track is a 2-day programme delivering proven strategies and real-world case studies tackling the COGs crisis and scalability challenges for autologous and allogeneic cell therapies. Discover how to implement closed systems and automation at scale while leveraging novel analytical technologies for process and product characterization. Master the approaches that ensure consistency, quality, and an accelerated pathway to regulatory approval.
Session Spotlight: Automation and Closed Systems
Automated Closed-System Expansion of Pluripotent Stem Cells: Enhancing Process Consistency and Reproducibility for Cell Therapy Manufacturing
Thursday, September 24, 2026 2:45 PM
Sheila Sharifzad, Process Development Scientist – Cell Therapy at Bayer
Pluripotent stem cell (PSC)-based therapies hold transformative potential for regenerative medicine, yet their translation to clinical and commercial scale is hindered by process variability inherent to manual cell culture operations. This work presents the development of a fully closed, automated process for PSC expansion that standardizes all critical process steps, including vial thawing, cell feeding, passaging, and harvesting. By minimizing operator dependency across the entire workflow, this integrated approach significantly enhances process consistency and achieves high inter-run reproducibility. This advancement addresses a fundamental challenge in scalable cell therapy manufacturing by providing a robust and reliable framework for producing high-quality pluripotent stem cells suitable for downstream therapeutic applications.
Track Themes: A Blueprint for Industrializing Cell Therapies
Automation and Closed Systems
See how leaders are implementing closed, automated systems to scale 'off-the-shelf' allogeneic therapies.
Solving the COGS Crisis
Hear real-world case studies on how to optimize processes, cut costs at scale, implement meaningful automation, and leverage novel technologies to make ex vivo cell therapy manufacturing more efficient, scalable, and commercially viable.
Novel Analytical Technologies for Cell Therapy Product and Process Characterization
Discover cutting-edge analytical technologies and QbD strategies to identify and control CQAs, develop rapid characterization assays, and meet regulatory expectations for in-process controls, potency assays and release testing in cell therapy manufacturing.
Decentralized Manufacturing
Explore proven strategies for implementing decentralized cell therapy manufacturing at scale, addressing regulatory control, multi-site coordination, system integration, and patient-centric solutions to improve accessibility and reduce treatment burdens.