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Cited by 18Mesenchymal stem cell researchFluid Dynamics and MixingTissue Engineering and Regenerative Medicine

Needle to needle robot‐assisted manufacture of cell therapy products

Open access
Ochs, Jelena, Hanga, Mariana P., Shaw, Georgina, Duffy, Niamh, Kulik, Michael, Tissin, Nokilaj, Reibert, Daniel, Biermann, Ferdinand +9 more·2022·Bioengineering & Translational Medicine
DOI 10.1002/btm2.10387PMC PMC9472012
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Abstract

Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapies for untreatable diseases, generating the need for large volumes of high-quality, clinically-compliant GMP cells to replace costly, high-risk and limited scale manual expansion processes. We present the design of a fully automated, robot-assisted platform incorporating the use of multiliter stirred tank bioreactors for scalable production of adherent human stem cells. The design addresses a needle-to-needle closed process incorporating automated bone marrow collection, cell isolation, expansion, and collection into cryovials for patient delivery. AUTOSTEM, a modular, adaptable, fully closed system ensures no direct operator interaction with biological material; all commands are performed through a graphic interface. Seeding of source material, process monitoring, feeding, sampling, harvesting and cryopreservation are automated within the closed platform, comprising two clean room levels enabling both open and closed processes. A bioprocess based on human MSCs expanded on microcarriers was used for proof of concept. Utilizing equivalent culture parameters, the AUTOSTEM robot-assisted platform successfully performed cell expansion at the liter scale, generating results comparable to manual production, while maintaining cell quality postprocessing.

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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 Ochs et al., 2022

    The Results (AUTOSTEM platform overview and Sterility; page not provided) describe robot arms in a grade A isolator, and the Discussion describes 24/7 production and GMP-oriented design. The Introduction discusses modular processing components, but the copy does not establish that this particular setup is compact or demonstrate high-throughput, GMP-compliant manufacture; it calls the platform GMP-amenable and says cleaning validation will be performed. (LLM, conf=0.85)

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Research works printed but not linked: 36

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Authors
Ochs, J., Hanga, M. P., Shaw, G., Duffy, N., Kulik, M., Tissin, N., Reibert, D., Biermann, F., Moutsatsou, P., Ratnayake, S., Nienow, A., Koenig, N., Schmitt, R., Rafiq, Q., Hewitt, C. J., Barry, F., & Murphy, J. M.
Affiliations
  • Fraunhofer Institute for Production Technology IPT (DE)
  • Aston University (GB)
  • Ollscoil na Gaillimhe – University of Galway (IE)
  • University of Birmingham (GB)
  • Fraunhofer Institute for Production Technology (IPT) Aachen Germany
  • University College London (GB)
  • Regenerative Medicine Institute, Biomedical Sciences Building National University of Ireland Galway Galway Ireland
ORCID
Venue
Bioengineering & Translational Medicine
Publisher
Wiley
Published
2022-08-06
Volume
7
Issue
3
Pages
e10387-e10387
ISSN
2380-6761 (ISSN-L)
DOI
10.1002/btm2.10387
PMC
PMC9472012
OpenAlex
W4290075810
Cited by
18
References
0
Citations by year
2026: 2 · 2025: 7 · 2024: 2 · 2023: 5 · 2022: 2
FWCI
2.49
Type
journal article
Language
en
Open access
Licence
Locations
  • Bioengineering & Translational Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Fraunhofer-Publica (Fraunhofer-Gesellschaft) (submittedVersion, cc-by)
Funders
European Commission (667932)
Topics
  • Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
  • Physical Sciences › Engineering › Biomedical Engineering › Fluid Dynamics and Mixing
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
Keywords
cell therapy manufacturing, human mesenchymal stem cells, cell isolation, cryopreservation, stirred tank bioreactor, process automation

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