ArticleBioengineering & translational medicine2025
Establishing a scalable perfusion strategy for the manufacture of CAR-T cells in stirred-tank bioreactors using a quality-by-design approach.
Article in Bioengineering & translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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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.
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Who cites it
8 citing papers in PubMed.
- Review
- Are we there yet? The road to faster and more efficient CAR T cell manufacturing.Journal of biological engineering · 2026Review
- Impact of physical and chemical parameters on spinoculation for chimeric antigen receptor T cell manufacturing using a quality-by-design approach.Molecular therapy. Advances · 2026Article
- CAR-macrophages in solid tumors: promise, progress, and prospects.NPJ precision oncology · 2025Review
- Impact of Serum/Xeno-Free Medium and Cytokine Supplementation on CAR-T Cell Therapy Manufacturing in Stirred Tank Bioreactors.Biotechnology journal · 2025Article
- Establishing a scalable perfusion strategy for the manufacture of CAR-T cells in stirred-tank bioreactors using a quality-by-design approach.Bioengineering & translational medicine · 2025Article
- Scalable CAR-T production in a 2-litre perfusion stirred-tank bioreactor with automated harvesting and scale-down model characterisation.Frontiers in bioengineering and biotechnology · 2025Article
- Optimising and adapting perfusion feeds in serum-free medium to intensify CAR-T cell expansion in stirred-tank bioreactors.Frontiers in bioengineering and biotechnology · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Chimeric antigen receptor T cell (CAR-T) therapies show high remission rates for relapsed and refractory leukemia and lymphoma. However, manufacturing challenges hinder their commercial viability and patient accessibility. This study applied quality-by-design principles to identify perfusion critical process parameters for CAR-T expansion in stirred tank bioreactors to maximize yields. A design of experiments in the Ambr® 250 High Throughput Perfusion small-scale bioreactor revealed that earlier perfusion starts (48 h vs. 96 h post-inoculation) and higher perfusion rates (1.0 VVD vs. 0.25 VVD) significantly increased cytotoxic CAR-T cell yields without compromising critical quality attributes. Optimizing perfusion improved growth kinetics and yields across donor samples, achieving densities >21 × 10
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Registered trials
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