Tuesday 10th March - Main Conference Day OneTuesday, 10 March 2026 - PT (Pacific Time, GMT-08:00)

Digital twins are revolutionizing manufacturing by creating virtual replicas of processes, enabling rapid scenario testing, de-risking tech transfer, and accelerating scale-up. This session will feature case studies on how advanced analytics and hybrid models (mechanistic + AI/ML) are driving more efficient process development, reducing variability, and lowering costs. Discussion will include regulatory perspectives and cross-functional adoption strategies.

Case studies on optimizing purification processes to manage high upstream titers, including new capture methods, improved resins, and process adjustments to maintain product quality.

Presentations on implementing continuous downstream technologies and hybrid approaches to intensify processes, reduce footprint, and enhance product consistency. Talks will highlight how digital twins, predictive modeling, and AI/ML tools are driving efficient process design and real-time control in continuous operations.

Case studies on scaling allogeneic (off-the-shelf) cell therapies from lab to commercial scale, with emphasis on process modeling, automation, and strategies to reduce cost of goods

A forward-looking discussion on how manufacturing innovation, digitalization, and improved supply chains can expand patient access and to viable business cases.

This panel will move beyond the “which is better” debate to address how leading companies evaluate and select the right upstream strategy across their portfolios. Experts will share case studies and business studies on decision-making frameworks, considering factors such as molecule type, clinical phase, cost of goods, regulatory expectations, facility readiness, and long-term scalability. Discussions will also explore the role of modeling, digital twins, and AI-driven analytics in simulating productivity and risk trade-offs between fed-batch, intensified, and fully continuous processes.

Digitalization is as much about people and strategy as it is about technology. This session will explore how senior leaders are overcoming organizational and cultural barriers to digital adoption. Talks will address governance frameworks, workforce reskilling, and strategies for building digital maturity across global networks. Real-world examples will highlight how leaders are aligning digital roadmaps with business priorities and regulatory expectations.

Case studies highlighting analytical and QC strategies for CGT products, including rapid potency testing, impurity monitoring, and chain-of-identity management for autologous therapies.

A comparative panel on the unique manufacturing, supply chain, and scalability challenges of autologous vs. allogeneic approaches, with emphasis on future trends and digital tools for decision-making.