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Table 1 BMSC lot release criteria

From: The establishment of a bank of stored clinical bone marrow stromal cell products

Test Method Criteria
CD73 Flow cytometry ≥80% reactive cells
CD90 Flow cytometry ≥80% reactive cells
CD105 Flow cytometry ≥80% reactive cells
CD146 Flow cytometry ≥60% reactive cells
CD34 Flow cytometry ≤5% reactive cells
CD45 Flow cytometry ≤5% reactive cells
CD14 Flow cytometry ≤5% reactive cells
CD11b Flow cytometry ≤5% reactive cells
Viability Trypan blue ≥70%
Sterility Bactec Plus, aerobic and anaerobic No growth after 14 days
Mycoplasma PCR Negative
Endotoxin Limulus Amebocyte Lysate (LAL) < 5.0 EU/mL