ReviewBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2021
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design.
Review in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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.
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.
Who cites it
20 citing papers in PubMed.
- Multi-Scale Hybrid Modeling to Predict Cell Culture Process With Metabolic Phase Transitions.Biotechnology and bioengineering · 2026Article
- Cardiac-Derived ECM Microspheres for Enhanced hiPSC-CMs Maturation.Advanced functional materials · 2026Article
- Hypoxia-induced metabolic and apoptotic reprogramming enhances immunomodulation in Wharton's jelly mesenchymal stem cells.iScience · 2026Article
- Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications.Advanced biomedical research · 2026Review
- Scale-down optimization of a robust, parallelizable human induced pluripotent stem cell bioprocess for high-throughput research.Biotechnology reports (Amsterdam, Netherlands) · 2025Article
- Quality and Regulatory Requirements for the Manufacture of Master Cell Banks of Clinical Grade iPSCs: The EU and USA Perspectives.Stem cell reviews and reports · 2025Review
- Unveiling distinctions between mesenchymal stromal cells and stem cells by single-cell transcriptomic analysis.Heliyon · 2025Article
- Advancements in theFrontiers in toxicology · 2025Review
- The Last Mile in Beta-Cell Replacement Therapy for Type 1 Diabetes: Time to Grow Up.Transplant international : official journal of the European Society for Organ Transplantation · 2025Review
- Fetal bovine serum: how to leave it behind in the pursuit of more reliable science.Frontiers in toxicology · 2025Review
- Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee.Cytotherapy · 2024Review
- Review
- Injectable biodegradable microcarriers for iPSC expansion and cardiomyocyte differentiation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Robotics-Driven Manufacturing of Cartilaginous Microtissues for Skeletal Tissue Engineering Applications.Stem cells translational medicine · 2024Article
- Assessment of Genetic Stability in Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes by Using Droplet Digital PCR.International journal of molecular sciences · 2024Article
- Public attitudes toward the use of human induced pluripotent stem cells: insights from an Italian adult population.Frontiers in public health · 2024Article
- Suspension culture improves iPSC expansion and pluripotency phenotype.Stem cell research & therapy · 2023Article
- Review
- Volumetric imaging of human mesenchymal stem cells (hMSCs) for non-destructive quantification of 3D cell culture growth.PloS one · 2023Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Human induced pluripotent stem cells (hiPSCs) are manufactured as advanced therapy medicinal products for tissue replacement applications. With this aim, the feasibility of hiPSC large-scale expansion in existing bioreactor systems under current good manufacturing practices (cGMP) has been tested. Yet, these attempts have lacked a paradigm shift in culture settings and technologies tailored to hiPSCs, which jeopardizes their clinical translation. The best approach for industrial scale-up of high-quality hiPSCs is to design their manufacturing process by following quality-by-design (QbD) principles: a scientific, risk-based framework for process design based on relating product and process attributes to product quality. In this review, we analyzed the hiPSC expansion manufacturing process implementing the QbD approach in the use of bioreactors, stressing the decisive role played by the cell quantity, quality and costs, drawing key QbD concepts directly from the guidelines of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Indexed as
Identifiers
What OpenQuestion holds
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.