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Updated: Jan 29, 2026

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
Published on: October 6, 2023
Freeze-dried and GMP-compliant pharmaceuticals containing exosomes for acellular mesenchymal stromal cell
Elia Bari1, Sara Perteghella1,2, Laura Catenacci1
1Department of Drug Sciences, University of Pavia, Viale Taramelli 12, 27100 Pavia, Italy.
Aim:
To validate the use of ultrafiltration (UF) as an alternative applicable industrial method to replace ultracentrifugation (UC) in the purification of mesenchymal stromal cell (MSC)-secretome.
Materials & Methods:
Pharmaceutical formulations containing secretome and/or extracellular vesicles were extracted from adipose-MSCs and bone marrow-MSCs by combining UF or UC with lyophilization.
Results & Conclusion:
UF led to higher protein, lipid, cytokine and exosomes yields compared with UC. The isolation procedure and cell source influenced immunomodulatory activity, which was in vitro evaluated by inhibition of phytohemagglutinin-activated peripheral blood mononuclear cell proliferation, and by modulation of IL-10, IFN-γ and IL-6. A secretome dosage was identified to obtain the same immunomodulatory activity of MSCs, paving the way for cell-free therapy.
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