NecstGen and Aarhus University Collaborate in Groundbreaking Initiative for GMP-Compliant Stem Cell Production

NecstGen and Aarhus University Collaborate in Groundbreaking Initiative for GMP-Compliant Stem Cell Production

Leiden November 16th, 2023 — NecstGen, Netherlands, a pioneering biotechnology center and non-profit CDMO specialising in Gene and Cell therapy, is proud to announce its groundbreaking collaboration with the Center for Gene and Cellular Therapy at Aarhus University Hospital (AUH), Denmark. This partnership aims to advance the production of mesenchymal stromal cells (MSCs) for experimental clinical use, ushering in a new era of advanced therapies and medical breakthroughs.

Mesenchymal stromal cells hold immense promise for regenerative medicine due to their remarkable ability to regenerate damaged tissue and regulate the immune system. However, their large-scale production while complying with strict Good Manufacturing Practice (GMP) standards has remained a challenge. NecstGen and AUH’s Center for Gene and Cellular Therapy are joining forces to address this challenge by introducing bioreactor-driven GMP-compliant MSC production processes.

Key Highlights of the Collaboration:

  • Advanced Bioreactor Use: Utilizing advanced bioreactors, the partnership will enhance MSC production, ensuring large-scale availability for clinical trials.
  • Strict GMP Adherence: Commitment to GMP standards guarantees the highest quality of MSCs, crucial for clinical use and future therapy commercialization.
  • Faster Clinical Trials: The initiative aims to fast-track the development of therapies for conditions like degenerative diseases and immune disorders through efficient MSC production.
  • Global Patient Impact: The collaboration is poised to make a substantial contribution to regenerative medicine, offering new treatment avenues for patients worldwide.
  • Scientific Excellence: Both entities are united in their pursuit of excellence, with a common goal to revolutionize healthcare through innovative cell therapies.

Dr. Melissa van Pel, Head of Cell Therapy at NecstGen, expressed her excitement about the collaboration, stating, “This partnership marks a significant milestone in the field of regenerative medicine. By combining our expertise with AUH’s Center for Gene and Cellular Therapy, we are poised to make substantial advancements in the production and clinical application of mesenchymal stromal cells.”

Dr. Bjarne K. Møller, Director of AUH’s Center for Gene and Cellular Therapy, added, “Our shared commitment to GMP compliance and rigorous scientific standards ensures that the MSCs produced through this collaboration will meet the highest quality and safety requirements. We are excited about the potential of this research to benefit patients in the near future.”

The collaboration between NecstGen, NL, and AUH’s Center for Gene and Cellular Therapy represents a leap forward in the field of regenerative medicine. Together, they aim to drive innovation, accelerate clinical development, and ultimately provide new hope for patients seeking advanced treatments for challenging medical conditions.

For media inquiries, please contact:

Tristan Pritchard-Meaker

Head of Business Development



Phone: +31 6253 44 672

About NecstGen:

The Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen) comprises a state-of-the-art facility for development and GMP manufacturing of Cell and Gene Therapies. NecstGen additionally offers cleanroom rental, Quality Control services and a Qualified Person to allow organisations to maintain control of production while de-risking the capital investment required to do so.


About Aarhus University Hospital’s Center for Gene and Cellular Therapy:

The Center for Gene and Cellular Therapy at Aarhus University Hospital is dedicated to advancing the field of regenerative medicine through research, development, and clinical applications. Its mission is to bring cutting-edge therapies to patients with unmet medical needs.


Working at NecstGen: Sydney Langerak

Working at NecstGen: Sydney Langerak

NecstGen is proud to have a state-of-the-art facility resulting from dedication and effort of our colleagues. Sydney Langerak, the Maintenance Technician overseeing Facility and Maintenance, played a pivotal role in shaping the company and its facilities. Today, he diligently maintains the equipment and pristine cleanrooms and shares his experiences at NecstGen.

A Journey of Technical Excellence

Sydney Langerak has a background in mechanical installations and maintenance, specifically in HVAC systems. He has 14 years of experience at the Leiden University Medical Center (LUMC), where he had many diverse responsibilities. Subsequently, Sydney was asked to join NecstGen to oversee the construction and set up maintenance.

“The opportunity at NecstGen came up, and it was an exciting challenge because I could be involved in the project from start to finish and also set up the maintenance. That’s unique because usually, you build something and then have to hand the project over to another department. Here, we do everything ourselves, which makes it special and one of the reasons I joined.” – Sydney Langerak, Maintenance Technician at NecstGen.

Inception to Completion: A Remarkable Journey

When NecstGen found a suitable place to build their cleanrooms, they had to strip down the third and fourth floors completely. Even some walls and floors were dismantled to allow for building and large equipment placement. Sydney was closely involved in the construction of the cleanrooms, working alongside Melissa van Pel, who handled the facility design. Both Sydney and Melissa were part of the team managing the consultants, engineers, and builders from outside organisations.

“I work with a fantastic team. In our Facility & Services department, I have two direct colleagues, and we are all responsible for the technical aspects. The Head of our department oversees all areas, including cleaning, inventory, and maintenance. Ronald van Tuijl and I focus on maintaining all in-house installations and ensuring they function properly. We were included in the construction process and witnessed it day by day.” –Sydney Langerak, Maintenance Technician at NecstGen.

A Day in the Life: Maintaining Excellence

A typical workday for Sydney begins at 7 a.m. and generally concludes around 4:30 p.m. Upon arriving at the workplace, he activates the building automation system to check for any overnight issues. If any concerns are identified, they are promptly addressed. A more normal day starts when the team turns on their computers and manages meetings and tasks. Each day presents unique challenges, and in the event of a malfunction, it can necessitate several hours to rectify. Furthermore, the team is constantly optimising maintenance procedures there is always room for improvement! The daily routine also involves monitoring the installations for any unusual occurrences and making necessary adjustments to ensure the facility’s smooth operation.

“Our Facility and Services department is open to helping everyone and willing to do whatever it takes. We are always there for each other, day, and night. Even after work hours, we are always available if needed. We back each other up, and it’s a mutually supportive environment. We are open, honest, and transparent, which, I believe, is the most effective way to work.” – Sydney Langerak, Maintenance Technician at NecstGen.

The Future at NecstGen: Opportunities Await

When considering career options at NecstGen, you can’t help but feel excitement as one envisions a future filled with growth and development. Opportunities for ongoing training and the potential to grow with the company promise a dynamic career path.

“The management is excellent. Because of our dynamic culture, the door of our CEO and senior management is always open. There are many opportunities at NecstGen to contribute. That makes my work interesting and, at the same time, enables me to grow in my career.” – Sydney Langerak, Maintenance Technician at NecstGen.

Working at NecstGen: Marten Visser

Working at NecstGen: Marten Visser

In this interview, we explore cell therapy with an expert from NecstGen, a reputable Contract Development and Manufacturing Organization (CDMO). We will uncover the complex and innovative work that characterizes their company culture while gaining insights into what makes working at NecstGen an exceptional experience in cellular medicine. We spoke with Marten Visser, a Cell Therapy Specialist, about his work at NecstGen.

Cell Therapy Specialist

Marten Visser, Cell Therapy Specialist at NecstGen, joined the company two years ago and played a significant role ever since. Before that, Marten worked at the Leiden University Medical Center (LUMC) at the Laboratory of Medical Oncology. He was devoted to T-cell therapy for melanoma and ovarian carcinoma. He specializes in cleanroom operation and research to enhance treatments and deepen the field’s understanding.

“I have experience in all parts of the process, from isolating T-cells from patient materials to handling GMP procedures. Because of my expertise, I can contribute to customer projects in many ways.”

When Marten was ready for a new challenge, NecstGen crossed his path. From the beginning, Marten witnessed and contributed to the company’s growth in multiple ways. His job at NecstGen proved the ideal opportunity to apply his knowledge in a broader context. So, in addition to his work as a scientist, he was closely involved in developing and improving processes.

“I thought about following a PhD program but was ready for something else. I wanted to use the knowledge I developed at the LUMC, and when I saw the position at NecstGen, there was a good match. I ended up in a startup: the cleanrooms only consisted of concrete. There were cables everywhere, it was bare, and there were workers everywhere. When I started, they had just begun contouring the cleanrooms on the third floor. Everything had to be built from scratch, and I actively contributed to that.”

A Dynamic Workday

A workday at NecstGen is dynamic and adaptable. Being a smaller company, the nature of responsibilities is diverse. For example, when the cleanrooms were still under construction, many workdays revolved around creating processes and corresponding documentation. Customer projects are more prominent now, resulting in many days of conducting experiments and working hands-on in the laboratory. Of course, there is also plenty of time dedicated to data analysis, tasks related to GMP adherence, and other responsibilities. On some days, meetings take precedence over other routine tasks. The diverse functions at NecstGen offer many opportunities for growth and learning.

“There’s much dedication at NecstGen: everyone believes in our mission to translate research programs into life-saving treatments. As a company, we are flexible and have the expertise and the commitment to assist customers in transitioning to GMP and production.”

All in all, working as a Cell Therapy Specialist at NecstGen comes with many opportunities. Each day differs, from working in the labs to ensuring GMP compliance. Close collaboration with colleagues and customers is crucial to their success. Working at NecstGen enables experts to develop as professionals in many ways, all while making a difference in the world by contributing to cell- and gene therapies.

Working at NecstGen: Warda Cardozo

Working at NecstGen: Warda Cardozo

Working at NecstGen: Warda Cardozo

NecstGen is a Non-Profit Contract Development and Manufacturing Organisation focused on enabling novel Cell and Gene Therapies. The state-of-the-art facility in the heart of the Leiden Bio Science Park in the Netherlands offers Cell Therapy, Viral Vector development, and manufacturing solutions for clinical researchers and industry to facilitate breakthroughs and innovation in healthcare.

We asked Warda Cardozo, Head of HR what it’s like to work at NecstGen and how cooperation is one of the key drivers in offering development support and GMP production of Cell and Gene Therapies.

The Team at NecstGen

NecstGen is a small company, powered by highly skilled professionals with big ambitions. The company has teams for Cell Therapy and Viral Vector. Experts within the Quality department provide Quality Assurance and Quality Control support. The Facilities & Services team underpins these divisions and consistently demonstrates operational excellence. In addition, the indispensable contributions of our business support divisions, including Business Development, Finance, and Human Resources, further bolster the enterprise.

At NecstGen, the flat hierarchy structure fosters an approachable, inclusive, and ‘decision making by consensus’ style environment. That was particularly evident when the compcaany obtained it’s GMP Manufacturing License last year.

‘During this critical period, I witnessed consistent dedication from each team member, with everyone collectively putting forth their utmost effort when it mattered most.’ – Warda Cardozo, Head of HR.

All employees of NecstGen display admirable dedication and diligence, which serves as a testament to the company’s strong work ethic. NecstGen values transparency and openness as part of its culture,reflected in various practices. For instance, the company holds regular meetings that involve the entire workforce to discuss progress and future plans.

‘Our team comprises individuals from various nationalities, resulting in a diverse and inclusive environment at NecstGen. Inclusivity is paramount in fostering a workspace where we can tackle challenges from different perspectives. This diversity allows us to cater to our client’s needs with the highest accuracy.’ – Warda Cardozo, Head of HR.

Personal development

NecstGen prioritises professional development within its organisational culture. Their mission is to accelerate Cell and Gene Therapies to patients. However, NecstGen also emphasises taking care of colleagues by offering personalised development plans that are meticulously designed to nurture growth opportunities within their current roles and career path.

‘As part of our commitment to individual growth, this year all employees were given the opportunity to participate in language courses focusing on either English or Dutch to enhance their communication proficiencies.’ – Warda Cardozo, Head of HR.

Additionally, NecstGen offers an internship program that promotes educational and professional growth. As active contributors to project initiatives, interns receive excellent support from their peers, supervisors, and the company. Groups of students seeking to understand the complexities of working with Cell and Gene Therapies are routinely welcomed by NecstGen, as they recognise the importance of nurturing and educating the next generation of potential employees in this field.

Working at NecstGen

At NecstGen, being an exemplary colleague means embodying the company’s core values, which place teamwork to cultivate an open and collaborative culture at the forefront. A flexible and cooperative mindset is essential for navigating the dynamic work environment. NecstGen highly values these qualities, which are crucial for colleague and company success.

Additionally, possessing solid expertise in the relevant field is considered paramount. Throughout the hiring procedure, applicants are asked to showcase their skills by preparing and presenting a business case, which is a fundamental component of our evaluation case-study.

‘At NecstGen, we prioritize identifying individuals who are not only qualified but are also passionate and unwaveringly dedicated to our mission to bring these innovative therapies faster to patients. We seek colleagues who share our firm commitment to this cause and value these qualities greatly.’ Warda Cardozo, Head of HR

At NecstGen, the working culture is vital to success. The open and collaborative environment gives space to contribute to the Regenerative Medicine ecosystem and facilitate the translation of promising novel Cell and Gene Therapies.

Are you looking for a position within NecstGen? Find current openings here.

What are iPSCs? And what is their potential?

What are iPSCs? And what is their potential?

What are iPSCs? And what is their potential?

The concept of reverting a cell to its most primitive and adaptable state is no longer a mere figment of imagination. This is the reality of induced pluripotent stem cells (iPSCs), which have the potential to morph into nearly any cell type in the human body. But how can this be harnessed for the betterment of patient care?

Stem Cell Spectrum

Stem cells are foundational cells with the unique ability to develop into various cell types in the body. They are primarily divided into two main categories: embryonic stem cells and adult stem cells.

Embryonic stem cells are extracted from the inner cell mass of embryos. These cells are pluripotent, which means they can transform into more than 200 different cell types in the body. Their versatility makes them a kind of “blank slate.” This inherent plasticity, self-renewal and differentiation potentials has made them a significant focus of scientific research.

What are induced Pluripotent Stem Cells (iPSCs)?

Introducing induced pluripotent stem cells (iPSCs) added a new dimension to the stem cell spectrum. iPSCs are generated from somatic cells, like skin cells, that have undergone genetic reprogramming to revert to a pluripotent state akin to embryonic stem cells. Due to their adult somatic origin, iPSCs have sidestepped many of the ethical concerns tied to embryonic stem cell research.

In summary, iPSCs emerged as a game-changer in stem cell research. By harnessing the potential of pluripotent cells and merging it with the patient-specific origin, they offer immense promise for therapeutic applications, disease modelling, and further scientific exploration.

Cellular Time Machines

The term “cellular time machines” aptly describes induced pluripotent stem cells (iPSCs). At their core, iPSCs are adult cells that have undergone a transformative process, allowing them to revert to an embryonic-like state. This reprogramming grants them the flexibility and adaptability characteristic of embryonic cells.

To understand this analogy, consider the life of a cell. As cells mature, they differentiate and become specialized, losing their original pluripotency. However, with iPSCs, scientists have found a way to reverse this process. It’s akin to turning back the hands of time on a cell’s life, restoring its youthful potential and versatility. This remarkable ability to revert mature cells to their primitive state is why iPSCs are often likened to “time machines” in the cellular world.

Yamanaka Factors: The Cellular Catalysts

In 2006, a pivotal shift occurred in stem cell research. Shinya Yamanaka and his team introduced the world to induced pluripotent stem cells (iPSCs). This discovery was not just another scientific finding; it represented a monumental leap, bridging the gap between the theoretical potential of stem cells and their tangible applications in medical science.

Central to creating iPSCs are the Yamanaka factors: Oct4, Sox2, Klf4, and c-Myc. These factors play a crucial role in the reprogramming process. When introduced into adult cells, they reactivate the dormant pluripotency genes, effectively rejuvenating the cell and reverting it to an embryonic-like state. It’s as if these factors hold the “keys” to unlocking the latent potential within cells, enabling them to regain their youthful flexibility and adaptability. This process has opened up new avenues in stem cell research, offering a more ethical and accessible way to harness the power of pluripotent cells.

Transformative Role of iPSCs in Regenerative Medicine

Induced pluripotent stem cells (iPSCs) are at the forefront of advancements in regenerative medicine, heralding a new era of therapeutic possibilities. Their inherent versatility is showcased in multiple ways.

For instance, they can potentially repair damaged tissues, such as cardiac tissues after a heart attack or neural tissues following spinal cord injuries*. This ability to regenerate and restore function to injured areas offers hope to many patients with limited treatment options.

Furthermore, the potential of iPSCs extends beyond tissue repair. Scientists are exploring their capacity to grow entire organs for transplantation*. Imagine a future where patients no longer have to wait on extensive donor lists for a life-saving organ. Instead, they could receive a custom-grown organ derived from their cells, diminishing the risks of organ rejection.

The adaptability of iPSCs is genuinely unparalleled. For instance, in neurodegenerative diseases like Parkinson’s, researchers are investigating how iPSCs can be used to replace damaged dopamine-producing neurons*. Similarly, in the field of diabetes research, there’s an ongoing exploration into how iPSCs can be transformed into insulin-producing beta cells, potentially offering a more definitive solution for diabetes patients*.

As the landscape of regenerative therapies continues to evolve, iPSCs stand out as a cornerstone. Their diverse applications, from tissue repair to organ generation, make them invaluable. With each research breakthrough, the promise of iPSCs broadens, bringing us closer to medical solutions that once seemed beyond our reach. As we delve deeper into the capabilities of these cells, the future of medicine looks brighter, offering hope for transformative treatments and cures.

Advancing Disease Modelling

Beyond their role in regenerative medicine, induced pluripotent stem cells (iPSCs) are pivotal in disease modelling and drug discovery. Generating patient-specific cells allows researchers to gain a more profound understanding of various diseases at a cellular level. This personalized approach provides a unique window into the intricacies of disease mechanisms, facilitating the identification of potential treatment pathways. As a result, iPSCs are accelerating the discovery of effective treatments and paving the way for potentially revolutionary cures in the medical landscape.

Ethical Advantages

Stem cell research, particularly involving embryonic stem cells, has long been at the centre of ethical debates. However, induced pluripotent stem cells (iPSCs) offer a distinct advantage in this contentious arena. Derived from adult cells, iPSCs eliminate the need to use embryos, sidestepping the primary ethical concerns that have overshadowed embryonic stem cell research. As a result, iPSCs present a more universally accepted approach, providing the scientific community with a powerful tool that aligns more harmoniously with ethical considerations.

The Future of iPSCs

Looking forward, the prospects for induced pluripotent stem cells (iPSCs) are incredibly promising. These cells hold the potential to drive unprecedented medical advancements, reshaping the landscape of healthcare. As research continues to delve deeper into the capabilities of iPSCs, we are on the cusp of transformative breakthroughs that could herald a new era in medical treatments and interventions. The journey of exploring iPSCs leads us towards a profound evolution in healthcare, with possibilities that were once deemed the stuff of science fiction now within reach.

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