Evidence map›Paper›PMID 39535315›Full record

ArticleBiotechnology and bioengineering2025

Perfusion Process Intensification for Lentivirus Production Using a Novel Scale-Down Model.

Maximilian Klimpel, Beatrice Pflüger-Müller, Marta Arrizabalaga Cascallana, Sarah Schwingal, Nikki Indresh Lal, Thomas Noll, Vicky Pirzas, Holger Laux

Abstract read
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Article in Biotechnology and bioengineering, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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

8 authors.

Maximilian KlimpelBiopharmaceutical Product Development, CSL Innovation GmbH, Marburg, Germany.ORCID 0000-0002-8041-1015
Beatrice Pflüger-MüllerBiopharmaceutical Product Development, CSL Innovation GmbH, Marburg, Germany.
Marta Arrizabalaga CascallanaUCL Department of Biochemical Engineering, University College London, London, UK.
Sarah SchwingalBiopharmaceutical Product Development, CSL Innovation GmbH, Marburg, Germany.
Nikki Indresh LalBiopharmaceutical Product Development, CSL Innovation GmbH, Marburg, Germany.
Thomas NollCenter for Biotechnology (CeBiTec), University of Bielefeld, Bielefeld, Germany.ORCID 0000-0003-0748-3423
Vicky PirzasBiopharmaceutical Product Development, CSL Innovation GmbH, Marburg, Germany.
Holger LauxBiopharmaceutical Product Development, CSL Innovation GmbH, Marburg, Germany.

Funding

This study was supported by CSL Limited.
6 · The paper itself

Abstract

Process intensification has become an important strategy to lower production costs and increase manufacturing capacities for biopharmaceutical products. In particular for the production of viral vectors like lentiviruses (LVs), the transition from (fed-)batch to perfusion processes is a key strategy to meet the increasing demands for cell and gene therapy applications. However, perfusion processes are associated with higher medium consumption. Therefore, it is necessary to develop appropriate small-scale models to reduce development costs. In this work, we present the use of the acoustic wave separation technology in combination with the Ambr 250 high throughput bioreactor system for intensified perfusion process development using stable LV producer cells. The intensified perfusion process developed in the Ambr 250 model, performed at a harvest rate of 3 vessel volumes per day (VVD) and high cell densities, resulted in a 1.4-fold higher cell-specific functional virus yield and 2.8-fold higher volumetric virus yield compared to the control process at a harvest rate of 1 VVD. The findings were verified at bench scale after optimizing the bioreactor set-up, resulting in a 1.4-fold higher cell-specific functional virus yield and 3.1-fold higher volumetric virus yield.

Indexed as

BioreactorsLentivirusHumansPerfusionVirus Cultivationgene and cell therapylentiviral vectorlentiviral vector productionperfusion process developmentsmall‐scale modelstable suspension producer cell line

Identifiers

PMID39535315
PMCPMC11718438

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Registered trials

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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.