Webinar

Transforming Your LV Process for CAR T to a Scalable, GMP-Ready Process

Key areas of focus include:

Transitioning from research to clinical application presents numerous challenges, particularly for CAR T developers, academic institutions, and small companies at a pivotal point in their development journey. This webinar is specifically designed to address these groups, aiming to refine their process development for clinical readiness. We will emphasize the need for a shift to a structured, data-driven methodology, crucial for meeting the stringent requirements of large-scale Good Manufacturing Practice (GMP).

Our objective? To help you understand the necessity of shifting from traditional, ad hoc methodologies to a structured, data-based development approach. This segment emphasizes the importance of embracing change and innovation to overcome the limitations of the “this is how we’ve always done it” mindset.

  • Quality by Design (QbD): a systematic development framework
  • Design of Experiments (DOE): understanding and improving your process
  • Scalability: designing a process that can be scaled up from the bench to large, industrial scale
  • USP & DSP: improving production and purification

Our experts can provide insights and answer your queries to advance your CAR T therapy development. This webinar is designed to help you, and if you have additional questions, we invite you to share your questions.

Webinar Product Quality For Cell Therapies

Webinar Product Quality For Cell Therapies

Product Quality For Cell Therapies

This session is set to be a compelling exploration of product quality in Cell Therapies.

Key areas of focus include:

As the field of regenerative medicine and Cell Therapies advances, it underscores a longstanding imperative: the quality, safety, and efficacy of these products has always been and remains the most crucial aspect of any therapy.

While a multi-faceted approach to quality is a standard across various therapies, Cell Therapies present unique challenges due to their nature as living therapies. Specifications for these products will inherently exhibit a range because they are derived from living cells. Consequently, testing strategies for Cell Therapies are more risk-based and require a tailored approach when compared to non-Advanced Therapy Medicinal Products (non-ATMPs).

  • Understanding Cell Therapies
  • The Importance of Product Quality
  • Building a Quality Strategy
  • Testing and Validation
  • Regulatory Landscape

Our experts can provide insights and answer your queries to advance your cell therapy development. This webinar is designed to help you explore and navigate the complexities of product quality strategies for cell therapies. If you have additional questions, we invite you to share them.

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

NecstGen

Email: tristan@necstgen.com

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.

Website: https://necstgen.com

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.

LinkedIn: https://www.linkedin.com/posts/center-for-gene-and-cellular-therapy-aarhus-university-hospital_celltherapy-genetherapy-cgctauh-activity-7018188460528136192-zHhs/?trk=public_profile_like_view

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.

We have a dynamic culture and 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

We explore the field of Cell Therapy with an expert from NecstGen, a Non-Profit Contract Development and Manufacturing Organisation (CDMO) for Cell and Gene Therapies. While examining the complex and innovative work that characterises the company’s activities, we also gain insights into what makes working at NecstGen an exceptional experience in cellular medicine. We spoke with Marten Visser, Cell Therapy Specialist, about his work at NecstGen.

Cell Therapy Specialist

Marten Visser joined the company two years ago and has played a significant role ever since. He has extensive experience in T-cell therapy development and manufacture to treat melanoma and ovarian carcinoma. He specialises in cleanroom operation and translational development to create treatments and deepen the field’s understanding.

“I have experience in all parts of the process, from isolating T-cells from patient material to final formulation all under GMP procedures. Because of my expertise, I can contribute to customer projects in many ways.” –  Marten Visser, Cell Therapy Specialist at NecstGen.

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 role at NecstGen proved the ideal opportunity to apply his knowledge in a broader context. So, in addition to his work in the NecstGen development laboratories, he was also closely involved in setting-up general GMP procedures and processes.

“I felt I was ready for something new. I wanted to use the knowledge I have gained in my previous role, and when I saw the available position at NecstGen, there was a good match. At that time the cleanrooms were being constructed. There were cables and construction 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 had the opportunity to actively contribute to this.” – Marten Visser, Cell Therapy Specialist at NecstGen.

A dynamic workday

A workday at NecstGen is dynamic and open. Being a smaller company there are diverse responsibilities offering scope for growth and development in new areas. For example, when the cleanrooms were still under construction, many workdays revolved around creating processes, procedures and the 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, discussion, and learning. On some days, meetings take precedence over other routine tasks. The diverse functions at NecstGen offer many opportunities for growth and learning.

“At NecstGen everyone is aligned with 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 translating their processes into GMP procedures and clinical production.” Marten Visser, Cell Therapy Specialist at NecstGen.

All in all, working as a Cell Therapy Specialist at NecstGen comes with many opportunities. Each day may be different, from working in the laboratories to writing GMP documentation. Close collaboration with colleagues and customers is crucial to their and NecstGen’s success. Working at NecstGen enables us to develop as professionals in many ways, all while making a difference to the world by contributing to novel Cell- and Gene Therapies.

NecstGen Services

We offer process development solutions, contract preclinical/ GMP manufacturing and cleanroom rental for Cell and Gene Therapies to clinicians, academic, small, medium, and large commercial organisations worldwide.

Viral Vector Manufacturing & Development

Cleanroom Rental

Cell Therapy Manufacturing & Development

About Us

NecstGen is a non-profit CDMO and Centre of Excellence for Cell and Gene Therapy located in a purpose-built GMP facility in Leiden, The Netherlands. Dedicated to the field of Cell and Gene Therapies, we provide expertise and
capacity to focus on patient solutions.

NecstGen

Team

Partners

History

Facility