Scaling Advanced Therapy Medicinal Products (ATMP) Manufacturing: Key Insights from ISPE’s Compilation Podcast Episode
A recent episode of the ISPE Podcast: Shaping the Future of Pharma brings together key voices from the advanced therapy medicinal products (ATMP) ecosystem to examine one of the most pressing challenges in the sector: how to move from today’s highly manual, resource intensive production methods to scalable, cost efficient, and patient ready industrialization.
This episode highlights insights from the 2025 ISPE Europe Annual Conference and features perspectives from leaders driving automation and manufacturability in the ATMP space:
Their combined expertise spans robotics, engineering, manufacturing strategy, and full process ATMP automation—providing listeners with a multifaceted view of what it will take to make advanced therapies accessible to far more patients.
The Cost Challenge at the Heart of ATMP Manufacturing
One of the core themes explored across this compilation is the persistent cost barrier surrounding ATMP production. Current workflows remain dominated by manual and semi automated processes, many of which evolved directly from early laboratory procedures. Moving these methods into good manufacturing practice environments introduces significant expense—from cleanroom requirements and specialized consumables to large staffing needs.
Speakers emphasize that while the industry has made progress in areas such as transportation logistics and supply chain resilience, the greatest opportunity for cost reduction lies directly within the manufacturing process itself. Cleanroom staffing alone represents a major burden, with facilities required to maintain high-grade environments for operations that still depend heavily on human intervention.
The episode outlines how workforce limitations, training demands, and inefficiencies in manual handling create both operational bottlenecks and elevated risk of error. As Marco Flori notes, the cumulative impact of these factors places therapies at price points accessible to only a small fraction of patients—an issue the industry widely acknowledges and is motivated to address.
Industrialization Through Standardization and Modular Automation
Throughout the episode, guests highlight a shared view: automation is essential, but it must be approached strategically. The next phase of ATMP growth will depend on standardized consumables, modular manufacturing platforms, and automation systems that integrate seamlessly with existing, proven tools rather than replacing them outright.
Dan Strange underscores that early-stage biotech companies rarely prioritize manufacturability during development. Their initial focus rightly centers on clinical efficacy, often relying on the best available technologies for early trials. The challenge emerges later, near approval, when processes must scale and industrialize. At this point, wholesale redesign becomes impractical, making adaptable automation solutions crucial.
By leveraging robotics, closed single-use systems, and modular process steps, manufacturers can begin shifting production out of high-grade cleanrooms and into more manageable environments. This transition can reduce contamination risks, improve operator consistency, and enable significant gains in yield, a factor that can influence the cost of goods more dramatically than efficiency improvements alone.
The Role of Consumable Standardization
Another recurring topic is the importance of standardizing consumables, such as tubing sets, sterile connectors, and bioreactor interfaces. Today, many consumables are designed for human dexterity, not robotic actuation. Standardization would unlock broader mechanization, promote vendor competition, increase supply chain reliability, and lower costs through increased production volumes.
Speakers draw parallels to other sectors that followed a predictable pattern: rapid diversification of technologies, followed by eventual convergence around shared standards. ATMPs appear to be in the early stages of this journey. Identifying pockets of similarity across therapy types and manufacturing methods will help the industry move toward unified processes that support higher throughput and greater affordability.
Scaling to Meet Future Patient Needs
The compilation also reflects the growing demand for ATMPs. As indications expand and therapies evolve from late-line to earlier-line treatments, production volumes will need to transition from hundreds of patients to tens of thousands—and eventually far more. Meeting that demand will require manufacturing approaches that can scale without exponential increases in cost or facility footprint.
Among the episode’s most striking examples is a conceptual shift from producing approximately 300 batches annually in a 100 m² cleanroom to potentially 10,000 batches in the same space through modular, closed, automated design. Although theoretical, it demonstrates the magnitude of change possible through industrialization.
Stories That Highlight Urgency
The episode also includes reflections on real patient experiences—both the transformative successes and the sobering reminders of why continued progress is essential. These stories reinforce that industrialization is not simply a technical challenge; it is a mission to expand access to life changing therapies and reduce the global inequities associated with current costs.
Listen to the Full Conversation
For those engaged in ATMP development, manufacturing, regulatory strategy, engineering, or automation, this compilation offers valuable insights into where the industry stands and where it is heading.
The episode provides an essential look at the technological, operational, and strategic advancements shaping the future of advanced therapies, exploring the collaborative work needed to make them accessible to patients who need them most.
