Turning promising stem cell research into therapies
How do you produce reliable cell therapies at scale?
Mesenchymal stem cells (or stromal cells) present a strong opportunity for scalable medical treatment, but how can they be scaled?
For patients waiting for a cure, they need therapies that can move beyond those “We're hopeful, but...” conversations.
For doctors and scientists helping people, they need treatments that are safe, can be produced consistently, and scaled responsibly, so they can deliver results.
That is the challenge – and the opportunity – behind mesenchymal stem cell (MSC) therapies.
These cells hold remarkable potential for life-changing applications in regenerative medicine and beyond. Approved MSC products treat a wide range of conditions, including spinal cord injury, critical limb ischemia, arthritis, graft-versus-host disease, and more.
But how are these cells able to grow and turn into effective therapies?
To grow stem cells reliably, researchers need the right environment and the right system to support them. That means choosing both the media that nourishes (or feeds) the cells and the vessels that help expand them consistently as the work moves toward production.
Researchers can make the right decision in the research phase but hit a snag later.
A media formulation that performs well during research may become difficult to source or manage at a commercial scale, while vessel formats optimized for early-stage experiments may create operational challenges as production volumes increase. Corning® MSCulture Max® Media, together with scalable and modular vessel technologies such as Corning CellSTACK® Culture Chambers, Corning HYPERStack® Cell Culture Vessels, Corning CellCube® System, and Corning Microcarriers were designed to support developers as they move from laboratory research toward larger-scale manufacturing environments.
When MSC therapies can be scaled, more patients have access to treatment.
Researchers are looking for ways to scale up their cell therapy research.
The hidden risk in early success
Imagine you’re a scientist in a lab. You choose cells to test, put them into a lab vessel like a “stack” (see photo below), which is filled with a medium for the cells to grow in.
For you, success with early stem cell research can (sometimes) look simple: cells grow well, timelines move forward, and the process appears to work.
But what succeeds at bench scale does not always succeed in manufacturing – where treatments are created at scale, so that people can have a chance at a cure.
Yoshi Shyu, Chief Scientific Officer and Director of Commercial Technology at Corning Life Sciences, works with researchers (like the one you’re imagining) to help make MSC therapies a reality for more patients.
Researchers have to choose their materials carefully, including these stack vessels called Corning CellSTACK culture chambers.
The Corning® HYPERFlask® Cell Culture Vessel helps labs scale up.
Looking outward
“Material needed for bench-scale research, like your culture platforms, media formulations, and vessel formats, they are usually based on convenience or historical use rather than scalability or commercial intent,” Shyu says. “That can create problems later.”
Now imagine you’re a biotech or pharmaceutical company trying to scale up this early research. Multiplying the results may be harder. A process may become too labor-intensive. It may be difficult to automate. It may rely on open handling steps that increase contamination risk. Media volumes, and therefore cost, rise quickly. Or it may lack the control needed to deliver the reproducibility regulators expect.
“As development progresses, those early choices can become harder to defend,” Shyu says. “These systems frequently fail to translate to large-scale manufacturing that aligns with the intended batch size, dosing strategy, manufacturing consistency or therapeutic indication.”
When those issues emerge late, teams are often forced into significant process redesign – adding time, cost, and risk at a stage when programs can least afford it.
“Sponsors often realize too late that media selected during early development cannot be economically sourced, prepared consistently, or managed at commercial scale,” he says, explaining that Corning MSCulture Max Media was developed with this broader challenge in view.
And what’s worse than operational setbacks? Leaving patients waiting for answers.
Building toward commercial reality
“In development, MSC expansion often happens through a series of manual steps: technicians opening vessels inside biosafety cabinets, exchanging media by hand, moving cells from one format to another, and managing separate pieces of equipment across the lab.
These workflows can support fast learning at a small scale. But as volumes grow, every open step adds labor, variability, and contamination risk.
Commercial manufacturing looks very different. The process must be more contained, connected, and consistent. Commercial experiences are designed to reduce operator intervention and support tighter control.
That transition is not always easy to retrofit.
Shyu’s advice is simple: “First, start with the end in mind.”
He suggests that teams ask harder questions during the development process: Can this process scale without becoming too labor intensive or too costly? Can it produce the same quality cells, batch after batch, as demand grows?
“Regulatory agencies prioritize reproducibility, process understanding, and control strategies over maximum throughput or growth rates,” Shyu says, adding that regional differences also complicate things.
“Anyone working with Corning has access to our highly trained application scientists,” Shyu says. “They can share information across regions and give them a chance at MSC therapies at a global level.”
In MSC development, the best process is not simply the one that grows the most cells the fastest. It is the one that can reliably deliver the right therapeutic cells, in the right way, over time, while being compliant with multiple regulations.
Solutions like Corning MSCulture Max Media will help make MSC manufacturing more consistent.
Corning’s application scientists help customers put products into practice
So a research team has decided to conduct their work with media and vessels optimized for later scalability. How can they optimize their materials with their workflow? That’s where Corning’s Field Application Scientists can make a difference.
Small inefficiencies early on, like extra handling steps, difficult transfers, disconnected equipment, or workflows that depend too heavily on operator technique, can become major obstacles as a process scales.
Corning’s Field Application Scientists work closely with customers, helping to evaluate process needs, identify workflow challenges, and recommend fit-for-purpose solutions based on the intended manufacturing strategy. From vessel selection and media considerations to scale-up planning and process fit, their support is designed to help teams make decisions that hold up beyond the lab.
Somewhere, someone is waiting
With MSCulture Max Media, scalable vessel technologies, and access to scientific expertise, Corning helps cell therapy developers build manufacturing strategies that support the journey from research to commercialization. By enabling more scalable and reproducible MSC production, these tools can help bring promising therapies closer to the patients who need them.