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  4. GMP-compliant manufacturing of biologically active cell-derived vesicles produced by extrusion technology

GMP-compliant manufacturing of biologically active cell-derived vesicles produced by extrusion technology

Journal of Extracellular Biology, 2022 · DOI: 10.1002/jex2.70 · Published: December 1, 2022

PharmacologyRegenerative MedicineBiomedical

Simple Explanation

Extracellular vesicles (EVs) are like natural delivery trucks for important molecules, offering a cell-free way to treat diseases. However, making enough EVs for treatments is hard. This study introduces a new method called BioDrone™, using cell-derived vesicles (CDVs) created through a special extrusion process, which allows to make lot more vesicles. These lab-made vesicles act like real ones and can be produced in large quantities following strict quality guidelines, paving the way for new anti-inflammatory and regenerative medicine treatments.

Study Duration
Not specified
Participants
Not specified
Evidence Level
Not specified

Key Findings

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    Extrusion technology generates nanosized vesicles in far greater numbers than naturally obtained EVs.
  • 2
    Umbilical cord mesenchymal stem cell (UCMSC)-derived CDVs exhibit a biological activity that is similar to UCMSCs or UCMSC-derived EVs.
  • 3
    A GMP-compliant process was established to allow the production of a large number of UCMSC-CDVs in a reproducible manner.

Research Summary

The study introduces a novel drug delivery platform technology, BioDrone™, based on cell-derived vesicles (CDVs) produced from diverse cell sources using a proprietary extrusion process. Physical, biochemical, and functional characterization results demonstrate the potential of CDVs to act as effective therapeutics, with UCMSC-derived CDVs exhibiting biological activity similar to UCMSCs or UCMSC-derived EVs. The establishment of a GMP-compliant process facilitates the preclinical and clinical evaluation of these emerging therapeutics in anti-inflammatory or regenerative medicine.

Practical Implications

Scalable Manufacturing

The extrusion technology allows for large-scale manufacturing of CDVs, overcoming limitations of natural EV production.

Therapeutic Potential

CDVs, particularly those derived from UCMSCs, exhibit promising therapeutic potential for anti-inflammatory and regenerative medicine.

Drug Delivery Platform

CDVs can serve as an efficient drug delivery system for active pharmaceutical biomolecules in broad applications.

Study Limitations

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