Evidence map›Paper›PMID 37790245›Full record

ArticleMolecular therapy. Methods & clinical development2023

Development of an automated manufacturing process for large-scale production of autologous T cell therapies.

Natalie Francis, Marion Braun, Sarah Neagle, Sabine Peiffer, Alexander Bohn, Alexander Rosenthal, Tanita Olbrich, Sophia Lollies, Keijo Ilsmann, Carola Hauck and 3 more

Open access · goldAbstract read
In one paragraph

Article in Molecular therapy. Methods & clinical development, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.7field-weighted citation impact, top 6% of its field
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

13 citing papers in PubMed, 16 citations in OpenAlex.

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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

13 authors at 2 institutions in 2 countries.

Natalie FrancisCell & Gene Therapy, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK.
Marion BraunCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Sarah NeagleCell & Gene Therapy, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK.
Sabine PeifferCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Alexander BohnCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Alexander RosenthalCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Tanita OlbrichCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Sophia LolliesCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Keijo IlsmannCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Carola HauckCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Bernhard GerstmayerCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Silvio WeberCellular Therapy, Industrial Workflow Development, Miltenyi Biotec B.V. & Co. KG, Friedrich-Ebert-Str. 68, 51429 Bergisch Gladbach, Germany.
Aileen KirkpatrickCell & Gene Therapy, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK.
Miltenyi Biotec (Germany) · DEAge UK · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Engineered T cell therapies have shown significant clinical success. However, current manufacturing capabilities present a challenge in bringing these therapies to patients. Furthermore, the cost of development and manufacturing is still extremely high due to complexity of the manufacturing process. Increased automation can improve quality and reproducibility while reducing costs through minimizing hands-on operator time, allowing parallel manufacture of multiple products, and reducing the complexity of technology transfer. In this article, we describe the results of a strategic alliance between GSK and Miltenyi Biotec to develop a closed, automated manufacturing process using the CliniMACS Prodigy for autologous T cell therapy products that can deliver a high number of cells suitable for treating solid tumor indications and compatible with cryopreserved apheresis and drug product. We demonstrate the ability of the T cell Transduction - Large Scale process to deliver a significantly higher cell number than the existing process, achieving 1.5 × 10

Indexed as

automationcell and gene therapycell therapyCliniMACS Prodigygene therapyGMPmanufacturingoncologyT cell therapytechnology transfer

Identifiers

PMID37790245
PMCPMC10544074
OpenAlexW4386797551

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.