In the rapidly evolving field of cell therapy, scalability and accessibility remain two of the biggest challenges for widespread patient impact. Cellistic, a leading company that is pioneering allogeneic cell therapy solutions, is tackling these obstacles head-on with its novel induced pluripotent stem cell (iPSC) technologies. In this interview, Stefan Braam, PhD, Founder & Chief Technical Officer of Cellistic, shares insights into the company’s journey, its innovative platforms—including Pulse™, Echo™, and the newly introduced Allo Chassis™—and how these advancements are poised to redefine cell therapy development as we known it.
With a clear focus on efficiency, cost reduction, and clinical translation, Cellistic is at the forefront of making off-the-shelf, immune-cloaked cell therapies a reality. Enjoy!
Interview with Stefan Braam, Cellistic Founder & CTO
Cade Hildreth: What inspired Cellistic to be created/founded and how has its vision evolved over time?
Stefan Braam: Cellistic was founded on a key realization: while autologous cell therapies are highly effective, their complex logistics, manufacturing challenges, lack of scalability, and high costs make them inaccessible to most patients—leaving many without the treatments they need.
With advances in autoimmune disease and solid tumor treatments, demand for cell therapies continues to grow. To address this challenge, we must fundamentally rethink how these therapies are developed. At Cellistic, we believe allogeneic cell therapy is the solution, and induced pluripotent stem cells (iPSCs) provide the most promising foundation to make this a reality.
We have developed the complex stem cell technologies necessary for effectively scaling iPSC-based therapies, with the goal of enhancing patient access to these life-changing treatments.
Cade Hildreth: What are key challenges that Cellistic aims to solve?
Stefan Braam, PhD: We’re tackling the biggest challenges in cell therapy development—high costs, lengthy timelines, and limited scalability—which prevent many patients from accessing the treatments they need.
By leveraging our expertise in stem cells and our proprietary Pulse™ platform for cell line development and Echo™ platform for cell differentiation and drug product manufacturing—we’re not just addressing inefficiencies; we’re actively changing the accessibility of cell therapies.
Cellistic’s technology platforms allows any cell therapeutic developer, either based on autologous technology, donor-derived technology or iPSC based, to seamlessly switch to an off-the-shelf allogeneic solution with much lower manufacturing costs and faster timelines.
Cade Hildreth: Cellistic’s recent introduction of Allo Chassis™promises to tackle some of the biggest hurdles in allogeneic therapies. How do you envision this product transforming not just cell line development processes, but the future possibilities of cell therapy itself?
Stefan Braam, PhD: Allo Chassis™ is the latest addition to our portfolio, offering ready-to-use, immune-cloaked iPSC lines that are HLA-null. These lines provide a strong starting point for cell line development, reducing development timelines by approximately 1.5 years compared to starting from scratch. The gene edits in Allo Chassis™ target B2M and CIITA, resulting in a functional knockout of HLA class I and II. These genes were selected based on market analyses, which identified them as the most targeted genes in allogeneic cell therapy.
Cade Hildreth: What specific innovations in the Allo Chassis™ directly contribute to making it a cost-effective solution for allogeneic therapies?
Stefan Braam, PhD: The Allo Chassis™ is an off-the-shelf resource of GMP compliant iPSC cell lines with key gene edits already incorporated, eliminating the need for developers to engineer their own starting materials. The cells also work well with our differentiation protocols, therefore reducing the risk, time and cost of the manufacturing process development.
By reducing development time and making a GMP compliant cell line available for drug product manufacturing process development, it’s a highly efficient solution for developing scalable, allogeneic therapies.
Cade Hildreth: What quality control measures does Cellistic implement to ensure the consistency and reliability of cell products?
Stefan Braam, PhD: At Cellistic, quality control is embedded in every stage of development to ensure consistency and reliability. Since we operate an EMA-certified GMP facility, we follow strict GMP principles from donor material to reprogramming, gene editing and cell banking.
Our Allo Chassis™ ready-to-use iPS cell lines has been manufactured under our own quality management system. Our approach integrates state of the art workflows, high-end automation, along with validated QC testing and analytical characterization to deliver a cell line that meets the highest regulatory standards.
Cade Hildreth: How does the integration of STAR-CRISPR™ technology within the Allo Chassis™ impact IP considerations and licensing for developers?
Stefan Braam, PhD: Cellistic owns the STAR-CRISPR™ editing technology used to create the gene modifications integrated in the Allo Chassis™, which give us a clear IP position, and allows us to make the cells available to our therapeutic development partners based on clear licensing terms.
With key gene edits already incorporated into the off-the-shelf cell lines, they can advance their therapies without additional gene-editing IP licenses. This streamlined approach reduces complexity and provides a clear path to commercialization with a transparent cost structure.
Cade Hildreth: What’s the impact of immune cloaking in the Allo Chassis™ iPSC cell lines on enhancing their customization and efficiency for therapeutic development?
Stefan Braam, PhD: Immune cloaking in the Allo Chassis™ iPS CD34+ and CD4+ derived cell lines enhances customization and efficiency by minimizing immune rejection, allowing for broader therapeutic applications. This reduces the need for patient-specific engineering, enabling faster and more cost-effective development. For a deeper understanding of the importance of cloaking, I invite you to read Suzanne Snellenberg’s article about Cloaking, which provides granular insights into this strategy— an area that is a core part of Cellistic’s expertise.
Cade Hildreth: How does the Allo Chassis™ off-the-shelf iPSC cell lines complement Cellistic’s cell line development and manufacturing solutions? And what advantages do they bring to therapeutic developers?
Stefan Braam, PhD: The Allo Chassis off-the-shelf iPSC cell lines complement Cellistic’s cell line development and manufacturing solutions by providing a ready-to-use, immediately available starting point for the development of a therapeutic product.
Cellistic offering is modular, and can be adapted to the client needs, Allo Chassis™ can be purchased as a standalone resource and further edited by developers, or they can partner with Cellistic for additional development and manufacturing, leveraging our cell line development platform (Pulse) and our differentiation and manufacturing platform (Echo).
Cellistic modular offering provides an attractive proposition for companies already working on iPSC-based processes or to therapeutic developers that intent to migrate to an off-the-shelf allogeneic approach in minimum time and with predictable costs.
Cade Hildreth: What unique technologies or innovations do you leverage in your cell manufacturing and differentiation processes?
Stefan Braam, PhD: Cellistic’s Echo™ platform offers scalable, pre-built differentiation and expansion protocols in bioreactors, utilizing chemically defined media and feeder-free conditions, all executed in an EMA-certified GMP facility.
Our EMA approved cGMP facility was designed with iPSC processes in mind, and can execute client processes as well as our Echo platform. Areas and equipment are validated to perform all unit operations, from cell banking to drug substance and drug product manufacturing. The product leaves our facility labeled and ready for clinical use.
This compliant and flexible infrastructure allows us to develop scalable manufacturing processes at fast pace while maintaining high standards of quality and reproducibility.
Cade Hildreth: How does Cellistic support clients in navigating regulatory challenges associated with iPSC-based therapies?
Stefan Braam, PhD: Cellistic supports clients in navigating regulatory challenges associated with iPSC-based therapies by providing expert guidance throughout the entire development and manufacturing process. Our team is well-versed in global regulatory requirements, and we ensure compliance with cGMP standards in our EMA-certified facility. We also assist clients in preparing for IND submissions, regulatory filings, and conducting the necessary quality control and analytical testing to meet regulatory expectations, helping streamline the path to clinical trials and commercialization.
Cade Hildreth: Off-the-shelf solutions are poised to revolutionize patient access to cell therapies; what developments do you foresee that will further validate their importance in the treatment landscape?
Stefan Braam, PhD: Since the first derivation of human pluripotent stem cells (hPSCs), significant advancements have been made in differentiation control and manufacturing, leading to a growing number of clinical trials using hPSC-derived therapies. As of December 2024, 116 clinical trials testing 83 hPSC-based products have received regulatory approval. These trials primarily target eye diseases, central nervous system disorders, and cancer.
To date, over 1,200 patients have been treated with hPSC-derived therapies, with more than 10¹¹ cells administered in clinical settings. Importantly, no generalizable safety concerns have been observed. The successful progression of iPSC therapies to late-stage clinical trials and eventual commercialization is crucial for the field, as it will validate their therapeutic potential and pave the way for broader adoption.
Cade Hildreth: What future developments or advancements can we expect from Cellistic that will further advance the field of cell therapy?
Stefan Braam, PhD: Cellistic is committed to driving the future of allogeneic cell therapy by continuously advancing our Pulse and Echo platforms. Our goal is to simplify, de-risk, and accelerate the development of immune cell-based therapies, making them more accessible and scalable.
Looking ahead, we will focus on:
- Enhancing the Pulse Platform: Expanding our portfolio of ready-to-use iPSC lines, including further immune-cloaking strategies and gene edits that improve persistence, functionality, and manufacturability.
- Advancing the Echo Platform: Optimizing differentiation and manufacturing processes to ensure highly efficient, scalable, and reproducible production of allogeneic cell therapies.
- Streamlining Clinical Translation: Developing processes that shorten process & analytical development timelines and increase regulatory confidence, supporting the successful transition of iPSC-derived candidate therapies into clinical trials and commercialization.
- Expanding Cell Therapy Applications: Exploring new immune cell types and engineering strategies to further broaden the impact of allogeneic therapies in oncology, autoimmune diseases, and beyond.
By continuing to push the boundaries of iPSC-derived therapies, Cellistic aims to be a key enabler in the successful clinical and commercial adoption of allogeneic cell therapies.
To learn more about Cellistic, please visit them at Cellistic.com.