Constraints in cell production became evident as cells emerged as viable therapeutics and biological drug producers — driving the cost of certain life-saving therapies to as much as USD 500,000 per dose. As automation increasingly presents a practical response to long-standing challenges in cell manufacturing, a small number of enterprises have taken the lead in redefining how cellular therapies may be produced at scale.
High therapeutic promise alone no longer meets the demands of advanced therapies. The path from biological potential to patient access is constrained by scalability and regulatory risk — challenges that place manufacturing automation at the heart of scientific progress. © Green Elephant Biotech.
Advanced Therapy Medicinal Products (ATMPs) encompass both blood-derived cells (e.g., Chimeric Antigen Receptor, or CAR T-cells) and non-blood cells (e.g., induced pluripotent stem cells, or iPSCs). Following the first approval of a commercially successful ATMP, these “living drugs” gained sustained scientific and industrial attention, with more than 2,000 ATMP-based clinical trials initiated worldwide to date (1).
In Europe, 25 ATMPs have been approved by the European Medicines Agency so far, seven of which either failed to renew their authorization or withdrew their application due to commercial limitations. This results in an effective approval success rate of 59%, which is lower than that observed for other medicinal products and underscores the gap between current manufacturing practices and regulatory expectations (2).
Automated cellular manufacturing offers more than cost-efficient scale-up. By improving process control, reproducibility, and documentation, automation directly supports the demonstration of safety and efficacy – key prerequisites for regulatory approval. For patients, this progress carries the promise of broader access to life-saving therapies, including the potential for localized, on-demand ATMP production (3).
Building on the successful integration of pipetting robots and robotic handling systems, automation-driven innovation continues to expand across ATMP bioprocessing. Among the diverse solutions now shaping the future manufacturing infrastructure of regenerative medicine, four players stand out: Cellares, Wilson Wolf Manufacturing, Ori Biotech, and Green Elephant Biotech.
Cellares: Cell therapy factory in a box
Cellares is widely recognized as a market leader, with its Cell Shuttle platform integrating multiple unit operations required for advanced therapy manufacturing. From cell selection to expansion, the system is designed to automate handling-intensive and quality-sensitive steps that traditionally represent major sources of variability in ATMP development.
The platform aims to modernize manufacturing facilities by enabling the parallel processing of up to 16 patient batches. While this full-stack automation has attracted significant interest from ATMP developers, its deep integration into predefined workflows also reveals a core limitation (4).
The physical footprint and capital expenditure associated with the Cellares “smart factory” may constrain its long-term suitability for clinical manufacturing industrialization due to rising facility costs.
Wilson Wolf Manufacturing: Automation of the tricky step
Wilson Wolf Manufacturing focuses on cell culture devices across multiple applications and is best known for its G-Rex® technology, which leverages principles of fluid mechanics. The system minimizes protocol disruption while ensuring uniform distribution of nutrients and oxygen throughout the cell culture.
This design enables consistent cell expansion without interrupting cell-to-cell signaling or altering growth conditions. Although G-Rex® is expected to support the scale-up of therapies for up to 45 patients per carbon dioxide incubator, the platform is not designed for seamless integration into an end-to-end workflow (5).
As a result, substantial supporting infrastructure remains necessary for upstream and downstream manufacturing steps.
Ori Biotech: Digitally-regulated ecosystem
Ori Biotech represents a digitally driven approach to advanced manufacturing, offering a closed ecosystem that automates and digitizes labor-intensive stages of ATMP production. Its IRO® platform places a strong emphasis on reducing regulatory uncertainty by providing real-time process monitoring and data-driven feedback.
Given that regulatory complexity remains one of the most significant challenges faced by ATMP developers, Ori Biotech has steadily expanded its network since 2024 (6).
However, development-stage protocols — frequently revised and optimized in ATMP programs — can be difficult to accommodate within the IRO® platform’s digitally controlled framework.
Green Elephant Biotech: Advantages built on the disadvantages of others
Green Elephant Biotech differentiates itself by preserving workflow flexibility within an end-to-end manufacturing context – an attribute often limited in highly integrated automation platforms. Its flagship technology, CellScrew®, addresses both biological and mechanical variability at the process level, enabling reproducible cell cultivation and scalable transfer from R&D to GMP environments.
Rather than imposing rigid, capital-intensive manufacturing architectures, Green Elephant Biotech delivers sustainable infrastructure that integrates seamlessly into existing facilities. This approach supports a broad range of applications, including vaccine manufacturing and HEK-293 seed train expansion.
The underlying principle of CellScrew® – a dynamic 2D culture system for adherent cells enables the production of traceable and clinically effective therapeutics with a reduced risk of contamination. This design therefore fosters patient access through more decentralized and adaptable manufacturing strategies.
The trajectory of cell manufacturing is increasingly defined by convergence rather than competition, bringing together automation, regulatory robustness, and biological understanding into manufacturing systems.
As ATMP pipelines move closer to clinical and commercial reality, the emphasis is shifting from fixed infrastructures toward adaptable platforms that support both early development and GMP-compliant end-to-end production. Green Elephant Biotech’s approach aligns closely with this shift.
The CellScrew® system has been shown to provide up to 33% reduction in handling time and harvest efficiency over 90%, making it comparable to bioreactors. These and further features of this automation-driven system address regulatory and manufacturing concerns persistent among the ATMP developers, successfully bridging the gap in the advanced therapy landscape.
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References:
- Melocchi, A, Schmittlein, B, Sadhu, S, Nayak, S, Lares, A, Uboldi, M, Zema, L, Robilant, BN, Feldman, SA, Esensten, JH, Automated manufacturing of cell therapies (2025), J Control Release, pp. 1-20. doi: 10.1016/j.jconrel.2025.02.057.
- Izeta, A, Cuende, N, Regulation of advanced therapies in Europe: Are we on the right track? (2023), Cell Stem Cell, pp. 1013-16. doi: 10.1016/j.stem.2023.07.004.
- Moutsatsou, P, Ochs, J, Schmitt, RH, Hewitt, CJ, Hanga, MP, Automation in cell and gene therapy manufacturing: from past to future (2019), Biotechnol Lett, pp. 1245-523. doi: 10.1007/s10529-019-02732-z.
- Autolus Therapeutics Explores the Feasibility of Adopting Cellares’ Cell Shuttle Platform. (2026). Sternberg, C, Contract Pharma. Available https://www.contractpharma.com/breaking-news/autolus-therapeutics-explores-the-feasibility-of-adopting-cellares-cell-shuttle-platform/ (Accessed 07 January 2026).
- ScaleReady announces series of G-Rex awards, topping $40 million in grants. (2025). Abbott, J, BioProcess Insider. Available https://www.bioprocessintl.com/upstream-downstream-processing/scaleready-announces-series-of-g-rex-awards-topping-40-million-in-grants (Accessed 07 January 2026).
- Ori Biotech’s IRO® Platform Receives FDA Advanced Manufacturing Technology (AMT) Designation. (2025). Businesswire. Available https://www.businesswire.com/news/home/20250903899010/en/Ori-Biotechs-IRO-Platform-Receives-FDA-Advanced-Manufacturing-Technology-AMT-Designation (Accessed 07 January 2026).
