Background
CAR-T cell therapies represent one of the most advanced modalities of cellular immunotherapy. However, developers face challenges balancing scalability, flexibility, quality, and cost when translating therapies from concept to clinic. Manufacturing remains a major hurdle — processes are often manual, open, resource-intensive, and variable, requiring high-grade cleanroom infrastructure and skilled personnel. At the same time, no single platform offers a universal solution: all-in-one systems simplify operations and reduce variability, while modular systems provide flexibility and scalability.
CCRM Nordic’s Approach
To address these challenges, CCRM Nordic established state-of-the-art CAR-T manufacturing workflows that reflect real-world developer needs. We established 12-day processes using both all-in-one systems (e.g., Miltenyi Biotec’s CliniMACS Prodigy®) and modular platforms (e.g., Cytiva’s Sepax™, Sefia™, and Xuri™ systems alongside Wilson Wolf’s G-Rex®) in parallel. Each workflow included T-cell isolation, activation, lentiviral transduction, expansion, and harvest — representing the complete manufacturing process from patient cell to CAR-T product.
Our Contribution
What made this work unique was our comparative and holistic approach. Rather than focusing on a single technology, we generated side-by-side insights into product quality, cost, and operational performance across both integrated and modular platforms.
Our work centered on three pillars:
- Industry-relevant workflows that mirror real-world CAR-T development practices and can be easily adapted to client needs.
- Comprehensive quality control (QC) covering key critical quality attributes (CQAs) such as safety, yield, viability, purity, impurity, potency, and immune phenotype.
- Detailed cost and performance analyses quantifying direct manufacturing costs per run and per million CAR-T cells with different platforms, helping developers make informed, evidence-based decisions.
This approach provides developers with transparent data to support platform selection and process optimization.
Results and Impact
Through this program, we achieved several key outcomes:
- Proof-of-concept CAR-T manufacturing data using both modular and all-in-one systems, demonstrating successful end-to-end production of CAR-T cells with industry-leading platforms.
- Comprehensive performance comparison between systems, detailing relative strengths in scalability, throughput, operator training requirements, and facility needs.
- Established QC methods encompassing all major CQAs of CAR-T cells, ensuring reliable and comparable assessment of product quality across platforms.
- Detailed direct manufacturing cost analyses mapping costs per run and per million CAR-T cells across various platforms, identifying major cost drivers and areas for potential optimization.
- Demonstrated process flexibility, showing that both integrated and modular systems can be adapted to different process requirements, cell sources, and manufacturing scales.
The outcomes are applicable to various cellular immunotherapies and will support developers with a clear, data-driven foundation for selecting the most suitable manufacturing platform — whether their goal is to maximize yield, reduce costs, or streamline operations. By combining deep technical expertise with a not-for-profit collaborative model, CCRM Nordic helps accelerate the path toward safe, effective, and accessible CAR-T therapies.