Development of a robotic cluster for automated and scalable cell therapy manufacturing
Open accessPublished version of a preprint
Abstract
BACKGROUND AIMS: The production of commercial autologous cell therapies such as chimeric antigen receptor T cells requires complex manual manufacturing processes. Skilled labor costs and challenges in manufacturing scale-out have contributed to high prices for these products. METHODS: We present a robotic system that uses industry-standard cell therapy manufacturing equipment to automate the steps involved in cell therapy manufacturing. The robotic cluster consists of a robotic arm and customized modules, allowing the robot to manipulate a variety of standard cell therapy instruments and materials such as incubators, bioreactors, and reagent bags. This system enables existing manual manufacturing processes to be rapidly adapted to robotic manufacturing, without having to adopt a completely new technology platform. Proof-of-concept for the robotic cluster's expansion module was demonstrated by expanding human CD8+ T cells. RESULTS: The robotic cultures showed comparable cell yields, viability, and identity to those manually performed. In addition, the robotic system was able to maintain culture sterility. CONCLUSIONS: Such modular robotic solutions may support scale-up and scale-out of cell therapies that are developed using classical manual methods in academic laboratories and biotechnology companies. This approach offers a pathway for overcoming manufacturing challenges associated with manual processes, ultimately contributing to the broader accessibility and affordability for personalized immunotherapies.
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Integrating robotic arms within isolator systems represents a promising hybrid approach, enabling high-throughput, GMP-compliant cell manufacturing in compact, modular setups.
“Integrating robotic arms within isolator systems represents a promising hybrid approach, enabling high-throughput, GMP-compliant cell manufacturing in compact, modular setups (Melocchi et al., 2024; Ochs et al., 2022).”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Melocchi et al., 2024
The Robotic Cluster Design section describes a robotic arm surrounded by task-specific modules, and the Discussion says the system could support parallel processing and scale-up in a small footprint. But the paper does not describe integrating the arm within an isolator or establish GMP compliance; the Sterility of Robotic Processing section reports a proof-of-concept test in a standard, non-cleanroom laboratory. (LLM, conf=0.89)
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Cites
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Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17 · see citing works
- Authors
- Melocchi, A., Schmittlein, B., Jones, A. L., Ainane, Y., Rizvi, A., Chan, D., Dickey, E., Pool, K., Harsono, K., Szymkiewicz, D., Scarfogliero, U., Bhatia, V., Sivanantham, A., Kreciglowa, N., Hunter, A., Gomez, M., Tanner, A., Uboldi, M., Batish, A., Balcerek, J., Kutova-Stoilova, M., Paruthiyil, S., Acevedo, L. A., Stadnitskiy, R., Carmichael, S., Aulbach, H., Hewitt, M., Jeu, X. D. M. D., Robilant, B. D., Parietti, F., & Esensten, J. H.
- Affiliations
- University of Milan (IT)
- Harvard University (US)
- University of California, San Francisco (US)
- Marlboro College (US)
- Thermo Fisher Scientific (Germany) (DE)
- Charles River Laboratories (United States) (US)
- Thermo Fisher Scientific (United States) (US)
- Corresponding author
- Melocchi, Alice
- ORCID
- Venue
- Cytotherapy
- Publisher
- Elsevier BV
- Published
- 2024-09
- Volume
- 26
- Issue
- 9
- Pages
- 1095-1104
- ISSN
- 1465-3249 (ISSN-L)
- OpenAlex
- W4392872806
- Cited by
- 15
- References
- 1
- Citations by year
- 2026: 7 · 2025: 5 · 2024: 3
- FWCI
- 2.58
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Cytotherapy (publishedVersion, cc-by-nc-nd)
- bioRxiv (Cold Spring Harbor Laboratory) (acceptedVersion, cc-by-nd)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Physical Sciences › Engineering › Industrial and Manufacturing Engineering › Flexible and Reconfigurable Manufacturing Systems
- Physical Sciences › Engineering › Control and Systems Engineering › Robot Manipulation and Learning
- Keywords
- CAR T cell manufacturing, autologous cell therapy, CD8+ T cell proliferation, horizontal scaling, personalized immunotherapy, production cost reduction
- MeSH terms
- Receptors, Chimeric Antigen, Automation, Humans, Robotics, Immunotherapy, Adoptive, CD8-Positive T-Lymphocytes, Cell Culture Techniques, Bioreactors, Cell- and Tissue-Based Therapy
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