Related Experiment Video
Updated: Sep 29, 2026
Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow
Published on: March 17, 2023
Clinical manufacturing of adipose-derived stem cells for therapeutic use: current technologies, quality systems and
Alexandre Asch1, Daniel F Kalbermatten1,2, Srinivas Madduri1,2
1Division of Plastic, Reconstructive and Aesthetic Surgery, Geneva University Hospitals, Geneva, Switzerland.
Introduction:
This systematic review evaluated manufacturing technologies for adipose-derived stem cells (ADSCs), focusing on automation, quality control, potency, scalability, cost, and regulatory compliance.
Methods:
Following PRISMA guidelines, PubMed, Embase, and Web of Science were searched for English-language studies published January 2020-September 2025. Studies addressing clinical-grade ADSC manufacturing, quality control, regulatory compliance, or production economics were included; non-ADSC studies, reviews, case reports, and conference abstracts were excluded. Two reviewers qualitatively assessed methodological quality and bias. Heterogeneity precluded meta-analysis, so findings were synthesized narratively.
Results:
Forty-six studies were included; participant numbers were inconsistently reported, as the review focused on manufacturing processes. Automated bioreactors achieved 2- to 10-fold higher yields than flask-based approaches, with improved reproducibility and reduced contamination risk. Five validated platforms were identified. GMP production costs ranged from $15,000 to $50,000 per dose; automation offered potential reductions of 20%-40%. Key limitations included 3- to 5-fold inter-donor variability, 15%-25% batch-to-batch variation, and 5%-10% manufacturing failure rates.
Conclusions:
ADSC manufacturing is progressing toward scalable production, but clinical translation remains constrained by biological variability, limited potency-assay validation, high costs, and regulatory complexity. Standardization and clinically relevant potency assays are needed to improve consistency and access.
