ArticleACS omega2025
Digital Twin for the Production of hMSC-Derived Extracellular Vesicles for Applications in Cell and Gene Therapy toward Autonomous Operation.
Article in ACS omega, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Integrating Nuclear Magnetic Resonance into Bioprocess Control of Clinical-Grade Extracellular Vesicle Manufacturing.Journal of extracellular vesicles · 2026Review
- Engineering Small Extracellular Vesicles for Colon-Targeted Delivery: Microenvironment-Responsive Design, Therapeutic Mechanisms, and Clinical Translation.International journal of nanomedicine · 2026Review
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
No grant is acknowledged in the PubMed record.
Abstract
Cell and gene therapy are innovative advanced therapy medicinal products (ATMPs) whose importance for the treatment of various rare and challenging diseases has increased significantly in recent years. Due to their versatility and more flexible application, extracellular vesicles (EVs) show great potential compared to classical cell therapy. Autonomous processes help to reduce the facility footprint and the cost of goods (COG). This requires calibrated predictive process models which, in combination with state-of-the-art process analytical technologies (PAT) and an advanced process control (APC) strategy, guarantee consistent product quality in line with the quality-by-design (QbD) approach required by the regulatory authorities. In this study, a process was therefore developed that consists of two chromatographic purification steps after 3D cultivation of human mesenchymal stem cells (hMSC) on microcarriers and harvesting by depth filtration. The optimized multimodal size exclusion chromatography (SEC) is used for the efficient removal of proteins, and in the subsequent anion exchange chromatography (AEX), the strengths in DNA removal as well as the separation of intact and nonintact EVs are exploited. With a clearance of >98% of DNA and proteins, the regulatory thresholds with regard to DNA per dose and protein concentration are met. The required physicochemical-based mechanistic process models were calibrated for all unit operations. Furthermore, the potential of
Identifiers
What Socratic 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 Socratic graph.