A recent episode of the ISPE Podcast: Shaping the Future of Pharma tackles this issue head-on. Drawing on insights from the 2025 ISPE Europe Annual Conference, the episode brings together leaders from across the ATMP ecosystem to explore what it will take to move beyond today’s highly manual, resource-intensive production models and toward industrialized, automated manufacturing.
Expert Voices from the Front Lines of ATMP Manufacturing
The episode features perspectives from:
- Marco Fiori, Global Account Manager at Staubli Robotic UK
- David Phasey, Business Development Director at 3P Innovation
- Dan Strange, Chief Technology Officer and Co-Founder of Cellular Origins
Together, their expertise spans robotics, engineering, manufacturing strategy, and end-to-end ATMP automation. The result is a multifaceted conversation that blends technical insight with strategic foresight, offering listeners a clear picture of where the industry stands today and what must change next.
The discussion centers on the persistent cost barrier shaping ATMP access. Many current manufacturing workflows are still rooted in laboratory practices, relying heavily on manual or semiautomated steps. When these processes are transferred into GMP environments, costs escalate rapidly because of cleanroom requirements, specialized consumables, and large, highly trained workforces.
The speakers emphasize that although logistics and supply chains have grown more robust, the greatest opportunity for meaningful cost reduction lies directly on the manufacturing floor. Cleanroom staffing alone represents a substantial fiscal burden, particularly when human intervention remains central to processes that could be automated.
Rather than calling for radical reinvention, the episode underscores a more pragmatic path forward: industrialization through standardization and modular automation. ATMP’s next growth phase will depend on systems that integrate with existing, validated tools—reducing risk while enabling scale.
Modular automation, robotics, and closed, single-use systems offer a way through this challenge. By incrementally automating discrete process steps, manufacturers can shift operations out of high-grade cleanrooms, reduce contamination risk, improve operator consistency, and unlock significant yield improvements, often with a greater impact on cost of goods than efficiency gains alone.
Another cornerstone of the discussion is consumable standardization. Today, many consumables (tubing sets, sterile connectors, and interfaces) are designed for human hands, not robotic systems. This limits the scope of automation and reinforces dependence on manual labor. Standardization would enable broader mechanization, foster vendor competition, increase supply chain resilience, and drive down costs through higher manufacturing volumes.
The speakers draw parallels to other industries that followed a similar trajectory: rapid innovation and divergence, followed by convergence around shared standards. ATMP manufacturing appears to be at the beginning of this journey.
Scaling to Meet Tomorrow’s Patient Demand
As ATMPs move from late-line to earlier-line treatments, demand will increase dramatically. Manufacturing systems designed for hundreds of patients per year will need to scale to serve tens of thousands without proportional increases in cost or facility size.
One illustrative example discussed is the theoretical shift from producing roughly 300 batches annually in a 100 m² clean room to as many as 10,000 batches in the same footprint using modular, closed, automated designs. Though conceptual, this example highlights the magnitude of transformation industrialization could deliver.
Interwoven throughout the episode are reflections on real patient stories, powerful reminders that industrialization is not just a technical exercise. It is a mission to expand access, reduce inequity, and ensure that life-changing therapies reach the people who need them most.
Listen and Join the Conversation
For professionals involved in ATMP development, manufacturing, automation, engineering, or regulatory strategy, this episode offers essential insight into the future of advanced therapies.
Listen to the ISPE Podcast: Shaping the Future of Pharma to explore how collaboration, standardization, and smart automation are shaping a more scalable and more equitable future for ATMPs
