At NecstGen, scientists are focussing on bridging the gap between induced pluripotent stem cell (iPSC) research and clinical application. We spoke with Catalina Gomez-Puerto, Senior Scientist at NecstGen, about her journey in this field and the company’s strategic role in enabling iPSC-based innovations.
Catalina’s Background and Expertise
What inspired your interest in iPSCs, and what motivated your move to NecstGen?
I’m originally from Colombia, and when I started my undergraduate studies, Cellular Biology wasn’t offered as a standalone program. The main options were Medicine or Microbiology. I chose Microbiology because I was fascinated by how the human body responds to pathogens and wanted to explore that through research, rather than clinical practice.
Later, I received two scholarships to pursue a Master’s in Molecular and Cellular Life Sciences in the Netherlands. During my internship at the Hubrecht Institute, I worked with induced pluripotent stem cells (iPSCs) for the first time, and it was a turning point. The fact that these cells can become any cell type in the body is incredible! It opened my eyes to the possibilities of regenerative medicine.
During my PhD at UMC Utrecht, I focused on how hematopoietic and mesenchymal stromal cells maintain their stemness and avoid differentiating into mature cells like white blood cells or osteoblasts. That work deepened my interest in stem cell biology. For my postdoc, I wanted to move closer to clinical application, so I joined Leiden University Medical Center (LUMC) to study the molecular mechanisms behind Pulmonary Arterial Hypertension. Later, at Cambridge University, I returned to iPSCs, this time using them to model the disease in a patient-specific way.
Eventually, I moved into industry, where I focused on developing iPSC differentiation protocols, particularly for neurodegenerative applications. What really motivated my move to NecstGen was the opportunity to be one step closer to the patient. Here, I’m working on translating iPSC protocols into scalable, GMP-compliant processes for clinical manufacturing helping turn promising science into real therapies that can make a difference in people’s lives.
NecstGen’s Work with iPSCs
What makes NecstGen’s approach to iPSCs different?
What sets NecstGen apart is that we are a mission driven, non-profit organisation focused entirely on enabling the field of Cell & Gene Therapy to move forward. Our mission is to make advanced therapies accessible, and that means working alongside both academic groups and industry partners to translate iPSC research into clinical reality.
Being wholly owned by Leiden University Medical Center gives us a unique position. LUMC brings extensive expertise in pluripotent stem cell research and ongoing iPSC-based clinical activities, and that knowledge base is directly connected to our work. It allows us to combine scientific depth with the infrastructure and mindset required for GMP manufacturing.
We are development-focused, not just production-focused. That means we invest time in helping our partners design robust processes, analytical methods, and strategies that are reliable and reproducible at clinical scale. Our team of experts is actively engaged in this journey, rather than simply providing a service.
Current iPSC Projects and Challenges
What kind of iPSC-related projects are you working on?
We are supporting partners and clients with iPSC cell line generation, cell banking, process development, analytics, and GMP manufacturing.
For example, we are collaborating with Leiden University Medical Center (LUMC) on the RegMedXB U(iP)Scale project, which is part of the RegMed XB Diabetes Moonshot. The goal is to use iPSCs to develop regenerative therapies for Type 1 diabetes. Today, managing the disease means lifelong insulin administration using injections or pumps, along with constant glucose monitoring. iPSC-derived treatments could potentially restore the body’s ability to produce insulin, offering a real chance to cure the disease rather than just manage it.
In this project, NecstGen’s role is to demonstrate reliable scale up of stem cell-derived islets. Using bioreactors, we aim to facilitate scalable manufacturing. Technology transfer has been undertaken from LUMC into NecstGen’s process development laboratories, where our team is now collaborating with LUMC towards a cost-efficient, scalable manufacturing process.
What are the biggest challenges in iPSC differentiation, and how is NecstGen handling them?
One of the main challenges is ensuring that iPSCs develop into the right cell type for a specific therapy. For example, treating Parkinson’s disease requires generating dopaminergic neurons. We focus on making differentiation methods clinically viable, safe, and consistent so they can be used in treatments.
To achieve this, we optimise protocols through systematic process development, using a Design of Experiments (DoE) approach to identify and fine-tune the key parameters that influence differentiation outcomes efficiently. These can include cell seeding density, media composition, timing and concentration of growth factors, oxygen levels, and the type of culture surface or microcarrier system used.
Differentiation is highly sensitive to small variations, which is why it requires skilled personnel. Interpreting cell morphology, adjusting protocols based on subtle shifts in behaviour, and troubleshooting unexpected outcomes all demand deep stem cell expertise. Our team has hands-on experience with both adherent and suspension cultures across a range of iPSC-derived lines. By combining this expertise with robust experimental design and a quality-by-design mindset, we help our clients move from research protocols to GMP-ready differentiation processes with confidence.
NecstGen’s Expertise and Capabilities
What should potential clients know about NecstGen’s iPSC expertise?
At NecstGen we take a very different approach compared to many CDMOs that allows us to be truly collaborative and development oriented.
Within the Cell Therapy team, I work alongside Melissa van Pel, our Head of Cell Therapy, who sets the strategy and ensures that projects are designed with clinical translation in mind, and Óscar Bártulos, our Lead Scientist, who brings almost two decades of experience in pluripotent stem cells. Together, we integrate process development, analytical testing, and manufacturing expertise into a single, joined-up pathway.
My own focus is on process development for iPSC-derived therapies. That means helping partners design and optimise methods for iPSC expansion and differentiation—whether in adherent or suspension systems, with manual steps or in bioreactors. We make sure those protocols are robust, reproducible, and can be smoothly transferred into GMP cleanroom production.
Because we have purpose-built GMP cleanrooms, development labs, and in-house QC capabilities, we can support partners all the way from early-stage concepts through to GMP manufacturing. Our goal is always the same: to ensure the therapies developed with us are scientifically robust, technically feasible, and manufacturable under clinical conditions—ready to move into the clinic and, ultimately, to patients.
The Future of iPSC Therapies
Where do you see iPSC research heading, and what role will NecstGen play?
IPSCs are incredibly versatile, they can be used not just for cell replacement therapies, but also for disease modelling, drug discovery, and personalised medicine. Starting from a single donor sample, we can generate a virtually unlimited supply of therapeutic cells, which could truly transform how we treat disease.
Of course, there are still challenges. There is a need for more consistent and reproducible differentiation methods across laboratories and scales. Transitioning to GMP manufacturing can introduce hurdles regarding cost and scalability. And before these therapies can become standard practice, safety, long-term engraftment, and regulatory approval need to be addressed.
One exciting direction is creating iPSC lines that are less likely to trigger an immune response. This could make off-the-shelf therapies possible, using the same cells to treat many patients. If it works, it could be a game-changer, making treatments more accessible and moving beyond the need for patient-specific approaches.
Working at NecstGen
What do you enjoy most about your work?
Being part of a growing company means having the chance to shape processes and build something new. The team here is also very collaborative, everyone is working toward the same goal of making these therapies a reality.
Final Thoughts
Catalina and the NecstGen team are focused on moving iPSC-based therapies closer to the clinic. By combining scientific expertise with clinical manufacturing, NecstGen supports the translation of iPSCs from research to therapies.
