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Turning regenerative medicine from research to scalable production

Most breakthroughs in regenerative medicine never reach patients because they can't be produced at scale. Manual lab processes don't translate easily into consistent, industrial manufacturing, and that's where we come in.

 

At ReGEN Biomedical, we help partners bridge that gap. We combine cell biology, automation, bioprinting, and engineering under one roof, so you can move from a working protocol to a scalable, reproducible process, and ultimately, to clinical and commercial reality.

What we offer

We work with partners in three complementary ways. Whether you need to prove tissue production as a proof-of-principle, an existing protocol made scalable, or custom equipment built from the ground up, we can support you across the full path from lab to manufacturing.

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Development of equipment for tissue manufacturing

Some challenges in regenerative medicine simply don't have off-the-shelf equipment. Drawing on our engineering and biology expertise, we design and build custom automation solutions tailored to the specific tissue, scale and quality requirements of your work. This ranges from individual processing units or modules to integrated production lines.

This is for you if: the equipment you need doesn't exist yet, or existing systems don't fit your process. We focus on throughput, low shear stress, and consistent quality.

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Process development as a service

A protocol that works on the bench rarely works the same way at scale. We take your existing process and turn it into a scalable, reliable and manufacturing-ready process. We re-engineer steps, introduce automation where it adds value, and validate along the way.

This is for you if: you've proven a concept in the lab and now need to make it robust, reproducible, and ready for the next stage of process or therapy development.

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Empowering regenerative medicine by building knowledge & collaborations

To showcase the capabilities of our team and our facility, we run several projects in which we produce micro and macro tissue using automated workflows. These projects are predominantly grant-funded (subsidized) initiatives, aimed at driving innovation in regenerative medicine. Innovations are validated and we deliver proof-of-concept, with and for our partners.

 

This is for you if: you need knowledge and collaboration on the process development part of an innovative, regenerative medicine topic.

Our areas of expertise

Across these three offerings, our team brings hands-on experience in a broad range of cell biology, tissue engineering and automation techniques. Behind every capability listed below is an expert who's spent years working with it, meet the people who bring this expertise to your project.
 

We've grouped our capabilities into five categories below. Click on any category to see the specific techniques and platforms we work with.

  • hMSC expansion in small-scale stirred tank bioreactors

  • hMSC and chondrocyte expansion in plates

  • iPSC expansion in Vertical Wheel bioreactor

  • iPSC expansion in plates

  • Bioreactor expansion: adherent cultures using microcarriers

  • Bioreactor expansion: suspension cultures

  • Cell expansion on microcarriers

  • Static and dynamic microcarrier-based cultures in well plates

Don't see exactly what you need? Many of our techniques can be adapted, combined or extended for new applications.

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Our facility & quality approach

Quality is built into how we design and run our operations, not bolted on at the end.

 

A facility built for the work

Our laboratories are designed to support high-quality cell culture and advanced therapy development. The setup includes classified cleanroom environments and controlled laboratory spaces, with continuous environmental monitoring of particulates, temperature, humidity and pressure. This allows us to maintain controlled conditions and proactively manage contamination risks.
 

A quality system that scales with you

Our Quality Management System (QMS) ensures that all activities are performed in a controlled, traceable, and risk-based way. It integrates the processes you'd expect of a partner working toward clinical and commercial readiness, including Deviation Management, CAPA, Change Control, and Risk Management. Together, these support both our current R&D activities and the future transition to regulatory-compliant operations.

A clear pathway to GMP

While we currently operate in an R&D setting, our quality approach is guided by established industry standards, including ISO-based practices and GMP principles. Our facility is upgradeable, and our systems are designed to support a clear pathway toward regulatory-aligned development when our partners need it, whether that's early-stage development today or clinical and commercial production tomorrow.

How we work with partners

Every regenerative medicine project is different, so we adapt how we engage based on what you need. Most of our collaborations fall into one of three models:

Service engagement

You bring a defined need, such as tissue production, a process to scale, or a piece of equipment to design. We deliver against an agreed scope, with clear timelines and deliverables.

Joint development

We work side by side on a longer-term challenge, contributing our automation, scale-up and engineering expertise alongside your scientific and clinical knowledge. Our Development Program is one of the main routes for partners interested in this kind of collaboration.

Consortium partner

We participate in research consortia and (EU-)funded projects, contributing automation and scale-up know-how to multi-partner programs such as NEOLIVER, m2M and WISER.

Design partners

We bring our Functional Model, you bring your cells and materials. Together we validate the new equipment, and we adapt our design based on your feedback. Become a design partner and gain early access to next-generation equipment while helping shape its future development.

Ready to explore working together?

Whether you're scaling up a promising therapy, looking for a development partner, or trying to solve a manufacturing problem that doesn't have an off-the-shelf answer, we'd be glad to hear from you.

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©2026 by ReGEN Biomedical.

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