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. 2024 Apr 3;20(4):1207–1216. doi: 10.4103/NRR.NRR-D-23-01815

Table 1.

Release testing of SCEV

Assay Results
Sterility Negative
Endotoxin < 0.5 EU/kg body weight
Mycoplasma Negative
Particle concentration per mL 3.74 × 1011 ± 9.28 × 109
Particle mode size: between 50 and 200 nm 137.0
Protein content 0.48 mg/mL
Characterization by flow cytometry analysis CD81 90.5%
CD63 95.5%

EU: Endotoxin units, CD81 and CD63 are tetraspanins known to be enriched in exosomal membranes; SCEV: Schwann cell extracellular vesicles.