ArticleNature biotechnology2016
Quality cell therapy manufacturing by design.
Article in Nature biotechnology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 130 papers, 1 of them a synthesis that pooled 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.
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
130 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical manufacturing of adipose-derived stem cells for therapeutic use: current technologies, quality systems and production challenges.Regenerative medicinePooled it
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Induced pluripotent stem cells from discovery to translation.Nature medicine · 2026Review
- Validation of an automated total and viable cell counting for GMP-compliant production of human bone marrow stromal cells.Biotechnology reports (Amsterdam, Netherlands) · 2026Article
- Advances in Living Cell-Mediated Nanodrug Delivery Systems: Construction Strategies, Applications and Challenges.Pharmaceutics · 2026Review
- Harnessing immunity against breast cancer: from checkpoints to cell therapies.Journal of translational medicine · 2026Review
- Integrating Nuclear Magnetic Resonance into Bioprocess Control of Clinical-Grade Extracellular Vesicle Manufacturing.Journal of extracellular vesicles · 2026Review
- Laboratory Assessment and Clinical Outlook forAnnals of laboratory medicine · 2026Review
- Biochemical and Mechanical Signal Differentially Contribute to Survival in Surface-Modified Cell Model.Tissue engineering and regenerative medicine · 2026Article
- A decade of innovation in healthcare: Automation, bio-printing and digital twin technologies for personalized therapies.International journal of pharmaceutics: X · 2026Review
- Clinical translational research on stem cell products: prospects and challenges.Signal transduction and targeted therapy · 2026Review
- UNIQUE: ultrasound non-destructive in-situ quantitative evaluation of stem cell spheroid deformability during differentiation into specific lineages.Microsystems & nanoengineering · 2026Article
- Automated and scalable expansion of human liver organoids for translational applications.Journal of translational medicine · 2026Article
- Capacitance Technology Enables Automated Feeding, Improved Expansion, and Higher Throughput of CAR-T Cell Stirred-Tank Bioreactor Cultures.Biotechnology journal · 2026Article
- 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
- CD44-Binding Peptide-Functionalized Antibiofouling Polymer Surface for High-Performance Separation of Human Mesenchymal Stromal Cells.Chembiochem : a European journal of chemical biology · 2026Article
- De Novo Design Strategies of Nanomedicines for Diabetic Wound Microenvironment Remodeling.BME frontiers · 2026Review
- Engineered mesenchymal stem cell-derived extracellular vesicles as programmable biomaterial platforms for liver fibrosis: design principles, manufacturing and clinical translation.Frontiers in bioengineering and biotechnology · 2026Review
- Increased phenotypic and functional stability of human allospecific induced Tregs is associated with Vitamin C-mediatedFrontiers in immunology · 2026Article
- FP003B suppresses microcarrier aggregation and enhances cell yield in microcarrier-based mesenchymal stromal cell culture.Frontiers in bioengineering and biotechnology · 2026Article
70 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.
Indexed as
Identifiers
27054995What 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.