Evidence map›Paper›PMID 36994313›Full record

ArticleMolecular therapy. Methods & clinical development2023

Process intensification for lentiviral vector manufacturing using tangential flow depth filtration.

Robert M Tona, Reeti Shah, Kimberly Middaugh, Justin Steve, João Marques, Blair R Roszell, Cindy Jung

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 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.6field-weighted citation impact, top 4% 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

14 citing papers in PubMed, 18 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

7 authors at 2 institutions in 2 countries.

Robert M TonaCell and Gene Therapy, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA.
Reeti ShahCell and Gene Therapy, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA.
Kimberly MiddaughCell and Gene Therapy, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA.
Justin SteveCMC Analytical, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA.
João MarquesCell and Gene Therapy, GSK, Gunnels Wood Road, Stevenage SG1 2NY, UK.
Blair R RoszellCell and Gene Therapy, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA.
Cindy JungCell and Gene Therapy, GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA.
South College · USCell and Gene Therapy Catapult · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

For gene therapies to become more accessible and affordable treatment options, process intensification is one possible strategy to increase the number of doses generated per batch of viral vector. Process intensification for lentiviral vector manufacturing can be achieved by enabling perfusion in the production bioreactor when applied in tandem with a stable producer cell line, allowing for significant expansion of cells and production of lentiviral vectors without the need for transfer plasmids. Tangential flow depth filtration was used to achieve an intensified lentiviral vector production by enabling perfusion to expand cell density and allow for continuous separation of lentiviral vectors from producer cells. Hollow-fiber depth filters made of polypropylene with 2- to 4-μm channels demonstrated high filter capacity, extended functional life, and efficient separation of lentiviral vectors from producer cells and debris when used for this intensified process. We anticipate that process intensification with tangential flow depth filtration at 200-L scale from a suspension culture can produce on the order of magnitude of 10,000 doses per batch of lentiviral vectors required for CAR T or TCR cell and gene therapy that would require approximately 2 × 10

Indexed as

bioreactorcontinuous manufacturinglentiviral vectorsmanufacturingperfusionprocess intensificationtangential flow depth filtration

Identifiers

PMID36994313
PMCPMC10041461
OpenAlexW4323044139

What OpenQuestion 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 OpenQuestion graph.