Evidence map›Paper›PMID 36176619›Full record

ArticleBioengineering & translational medicine2022

Needle to needle robot-assisted manufacture of cell therapy products.

Jelena Ochs, Mariana P Hanga, Georgina Shaw, Niamh Duffy, Michael Kulik, Nokilaj Tissin, Daniel Reibert, Ferdinand Biermann, Panagiota Moutsatsou, Shibani Ratnayake and 7 more

Abstract read
In one paragraph

Article in Bioengineering & translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Review
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  9. Review
  10. Needle to needle robot-assisted manufacture of cell therapy products.Bioengineering & translational medicine · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Jelena OchsFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Mariana P HangaSchool of Biosciences, Life and Health Sciences College Aston University Birmingham UK.
Georgina ShawRegenerative Medicine Institute, Biomedical Sciences Building National University of Ireland Galway Galway Ireland.
Niamh DuffyRegenerative Medicine Institute, Biomedical Sciences Building National University of Ireland Galway Galway Ireland.
Michael KulikFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Nokilaj TissinFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Daniel ReibertFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Ferdinand BiermannFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Panagiota MoutsatsouSchool of Biosciences, Life and Health Sciences College Aston University Birmingham UK.
Shibani RatnayakeSchool of Biosciences, Life and Health Sciences College Aston University Birmingham UK.
Alvin NienowChemical Engineering University of Birmingham Birmingham UK.
Niels KoenigFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Robert SchmittFraunhofer Institute for Production Technology (IPT) Aachen Germany.
Qasim RafiqBiochemical Engineering, Advanced Centre for Biochemical Engineering University College London London UK.
Christopher J HewittSchool of Biosciences, Life and Health Sciences College Aston University Birmingham UK.
Frank BarryRegenerative Medicine Institute, Biomedical Sciences Building National University of Ireland Galway Galway Ireland.
J Mary MurphyRegenerative Medicine Institute, Biomedical Sciences Building National University of Ireland Galway Galway Ireland.ORCID https://orcid.org/0000-0003-0971-7684

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

automation: bioreactorscell therapyhuman stem cellsmanufacturing

Identifiers

PMID36176619
PMCPMC9472012

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.