ArticleBiotechnology and bioengineering2019
Computational fluid dynamics modeling, a novel, and effective approach for developing scalable cell therapy manufacturing processes.
Article in Biotechnology and bioengineering, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Novel, low-cost bioreactor forFrontiers in bioengineering and biotechnology · 2025Article
- Commercialization of Cell Therapies: A CDMO Perspective.Advances in experimental medicine and biology · 2025Review
- Standardized production of hPSC-derived cardiomyocyte aggregates in stirred spinner flasks.Nature protocols · 2024Article
- Suspension culture on microcarriers and as aggregates enables expansion and differentiation of pluripotent stem cells (PSCs).Cytotherapy · 2023Article
- Mesenchymal and induced pluripotent stem cell-based therapeutics: a comparison.Applied microbiology and biotechnology · 2023Review
- Stirred culture of cartilaginous microtissues promotes chondrogenic hypertrophy through exposure to intermittent shear stress.Bioengineering & translational medicine · 2023Article
- Characterization of human induced pluripotent stems cells: Current approaches, challenges, and future solutions.Biotechnology reports (Amsterdam, Netherlands) · 2023Review
- Manufacturing clinical-grade human induced pluripotent stem cell-derived beta cells for diabetes treatment.Cell proliferation · 2022Review
- Large-Scale Expansion of Human Umbilical Cord-Derived Mesenchymal Stem Cells in a Stirred Suspension Bioreactor Enabled by Computational Fluid Dynamics Modeling.Bioengineering (Basel, Switzerland) · 2022Article
- Advances in Manufacturing Cardiomyocytes from Human Pluripotent Stem Cells.Annual review of chemical and biomolecular engineering · 2022Review
- Patient-Specific Organoid and Organ-on-a-Chip: 3D Cell-Culture Meets 3D Printing and Numerical Simulation.Advanced biology · 2021Review
- Addressing Manufacturing Challenges for Commercialization of iPSC-Based Therapies.Methods in molecular biology (Clifton, N.J.) · 2021Review
- Cell-Based Therapy Manufacturing in Stirred Suspension Bioreactor: Thoughts for cGMP Compliance.Frontiers in bioengineering and biotechnology · 2020Review
- End-to-End Platform for Human Pluripotent Stem Cell Manufacturing.International journal of molecular sciences · 2019Article
- Computational fluid dynamics modeling, a novel, and effective approach for developing scalable cell therapy manufacturing processes.Biotechnology and bioengineering · 2019Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Induced pluripotent stem cells (iPSCs) hold great potential to generate novel, curative cell therapy products. However, current methods to generate these novel therapies lack scalability, are labor-intensive, require a large footprint, and are not suited to meet clinical and commercial demands. Therefore, it is necessary to develop scalable manufacturing processes to accommodate the generation of high-quality iPSC derivatives under controlled conditions. The current scale-up methods used in cell therapy processes are based on empirical, geometry-dependent methods that do not accurately represent the hydrodynamics of 3D bioreactors. These methods require multiple iterations of scale-up studies, resulting in increased development cost and time. Here we show a novel approach using computational fluid dynamics modeling to effectively scale-up cell therapy manufacturing processes in 3D bioreactors. Using a GMP-compatible iPSC line, we translated and scaled-up a small-scale cardiomyocyte differentiation process to a 3-L computer-controlled bioreactor in an efficient manner, showing comparability in both systems.
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Registered trials
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.