When Mariana Argenziano joined Ncardia, the potential of induced pluripotent stem cells was already well understood in drug discovery. What remained unresolved was whether these models could be produced with the consistency and control required to support real development decisions. As Associate Director of Manufacturing, that challenge defines her work.
Trained in molecular biology and stem cell biology, Argenziano spent much of her early career in academic research. But even though the science itself was rewarding, the outcome often felt incomplete. Thus, her move into industry was driven by a desire to see scientific work translated into something tangible. She wanted stem cell technologies to move beyond proof-of-concept and into real-world applications. Ncardia offered that opportunity, along with progress that depended on collaboration.
Variability is inherent to iPSC technology. Different donor lines and genetic backgrounds introduce differences that cannot be eliminated, only controlled. For Argenziano, that makes manufacturing discipline essential.
“Having robustness in your process is critical,” she said. “If not, it’s something you cannot control.”
At Ncardia, manufacturing relies on bioreactor-based differentiation, where oxygen, pH, metabolites, and other parameters are monitored continuously. This level of control supports reproducibility across batches and enables scaling without losing performance.
Manufacturing quality matters even more because Ncardia uses its own cells internally. The same products supplied to clients are used in discovery workflows and cardiotoxicity assays, creating clear and immediate performance expectations.
One principle underpins Argenziano’s approach: scalability cannot be added later. It must be built in from the start. Rather than generating cells first and deciding later how they will be used, Argenziano’s team starts with the intended application.
“We know what the cells need to do,” she said. “And then we make sure we make the cells for that purpose.”
Development proceeds through pilot batches until performance is stable and reproducible. Only then are processes moved into catalogue or custom production. This integrated setup removes the traditional handoff between R&D and manufacturing and reduces friction as workflows scale.
Maintaining batch-to-batch consistency depends on systems as much as science. Ncardia’s manufacturing relies on well-characterized cell banks, defined reagents, detailed workflows, and continuous in-process monitoring. Morphology, viability, aggregate size, differentiation progression, metabolites, and functional markers are tracked throughout production.
Equally important is historical context. Over time, Ncardia has accumulated data from more than 500 cardiomyocyte manufacturing runs. That dataset allows teams to compare each new batch against established performance patterns. When deviations appear, teams can investigate early or stop a run before further resources are invested. So, even though not all runs were successful, failures still contribute valuable information.
Bioreactors are central to Ncardia’s manufacturing approach, but Argenziano is clear that the technology continues to evolve. Automation in this space still trails behind more established industries.
To close that gap, Ncardia collaborates with bioreactor manufacturers, sensor developers, and automation partners. These collaborations allow emerging technologies to be tested in real manufacturing workflows and refined for broader use.
“We’re always trying to improve the technology,” she said, “to make sure we’re building something that will actually serve the industry.”
Across the industry, the shift toward human-based models is accelerating. With it comes pressure to manufacture iPSC-derived cells at larger scales, with higher throughput and tighter control.
Argenziano believes the biggest impact will come from fully controlled systems where environmental parameters and differentiation dynamics can be adjusted with precision. Ncardia is preparing by continuously optimizing its bioreactor platforms, strengthening in-process analytics, and expanding manufacturing capacity.
Because the company also develops assays and disease models internally, it has a clear benchmark for what “good” looks like. Manufacturing systems are designed to meet those expectations at scale.
Manufacturing is ultimately about impact. Reliable, human-relevant models help reduce uncertainty in drug discovery and support faster, better-informed decisions.
One project stands out. While details remain confidential, she describes supporting the development of a therapy for a severe neurodegenerative disorder using disease-relevant donor lines. Seeing promising data in that context reinforces why she moved into the industry.
In a field where new biology often advances faster than the infrastructure required to deliver it, Argenziano’s work highlights a central truth. Human relevance depends not only on the model itself, but on the ability to manufacture it consistently. At Ncardia, manufacturing is where biological promise becomes something drug developers can depend on.