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.
Actionable Insights from our Cell Therapy Experts
Explore the full Cell Therapy Manufacturing & Analytics Agenda
Cell Therapy Manufacturing & Analytics: Q&A & Expert Insights
Why is the transition to closed, automated systems critical for cell therapy?
Automating cell therapy manufacturing (e.g., using robotic isolators) removes human error and ensures sterility, which is essential for regulatory compliance. Closed systems enable the scalable production of both autologous and allogeneic therapies by maintaining a controlled environment from "vein-to-vein" and simplifying the validation of the manufacturing process.
What are the key bottlenecks limiting the scalability and affordability of CAR T cell therapies?
Despite clinical success, CAR T manufacturing remains constrained by complex, time-intensive, and resource-heavy processes that drive up costs and limit global access. Key challenges include donor variability in autologous products, inefficient isolation and expansion technologies, labor-intensive manual operations, and cryopreservation complexities. Addressing these bottlenecks requires strategic investments in closed-system automation, process intensification to increase yield per batch, advanced gene-editing platforms for allogeneic approaches, and optimized fill-finish processes that enable dose control and streamlined distribution networks.
What analytical strategies are essential for meeting regulatory expectations in cell therapy manufacturing?
Implementing Quality by Design (QbD) principles is critical for identifying and controlling Critical Quality Attributes (CQAs) throughout the manufacturing process. Manufacturers must develop rapid characterization assays that enable real-time decision-making, establish robust in-process controls, and design potency assays that accurately reflect the mechanism of action. Leveraging cutting-edge analytical technologies—including high-throughput automation, single-cell digital droplet PCR, and plate-based assay platforms—accelerates development timelines while ensuring products meet regulatory requirements for release testing and batch consistency.
How can decentralized manufacturing models improve patient access to cell therapies?
Decentralized manufacturing addresses critical barriers to patient access by reducing treatment burdens, minimizing logistics complexity, and enabling regional production closer to clinical sites. Success requires proven strategies for multi-site coordination, regulatory harmonization across facilities, robust system integration, and standardized processes that maintain product quality regardless of manufacturing location. This patient-centric approach not only improves accessibility for geographically dispersed populations but also reduces cold-chain dependencies and shortens vein-to-vein times for autologous therapies.