Journal of Translational Medicine

Table 2 MSC culture process validation

From: Clinical-scale expansion of mesenchymal stromal cells: a large banking experience

(a) Cultures rates
	1st Exp.	2nd Exp.	3rd Exp.
BM sample (mL)	28	52	55
MNC on day 0	180 × 10⁶	195 × 10⁶	260 × 10⁶
MSC on day 28	225 × 10⁶	165 × 10⁶	356 × 10⁶

(b) Phenotypes
Marker	Eligibility criteria (%)	1st Exp. (%)	2nd Exp. (%)	3rd Exp. (%)	Conformity
CD73	>70	96.9	99.9	99.4	Ok
CD105	>70	85.6	90.3	77.8	Ok
CD90	>70	100	98.2	100	Ok
CD34	<10	1.8	8.8	0.92	Ok
CD45	<10	1.1	1.10	0.55	Ok
HLA-DR	<10	0.84	0.63	0.52	Ok
CD80	<10	1.0	0.7	0.45	Ok
CD31	<10	1.0	0.9	0.62	Ok

(c) Post-thaw
Test	Eligibility criteria	1st Exp.	2ndExp.	3rd Exp.	Conformity
Initial cell number	Na	100 × 10⁶	70 × 10⁶	55 × 10⁶	Na
Initial viability	Na	95.8 %	82.5 %	86.0 %	Na
Post-thaw cell count	Na	100 × 10⁶	56 × 10⁶	43 × 10⁶	Na
Post-thaw cell viability	>50 %	89.5 %	78.0 %	78.0 %	Ok
Post-thaw cell culture expansion	Na	Ok	Ok	Ok	Na
Sterility	Sterile	Ok	Ok	Ok	Ok
Mycoplasma	Absence of mycoplasma	Ok	Ok	Ok	Na
Endotoxin	Endotoxin level <2.5 U.I./ml	Ok	Ok	Ok	Na

Phenotype
CD73	>70 %	99.5 %	96.1 %	87.9 %	Ok
CD105	>70 %	93.6 %	70.3 %	70.0 %	Ok
CD90	>70 %	100 %	99.6 %	99.8 %	Ok
CD34	<10 %	3.1 %	2.7 %	2.6 %	Ok
CD45	<10 %	1.0 %	1.9 %	1.0 %	Ok
HLA-DR	<10 %	1.0 %	1.2 %	1.0 %	Ok
CD80	<10 %	0.4 %	0.8 %	0.4 %	Ok
CD31	<10 %	0.6 %	1.2 %	0.6 %	Ok

Results of three large-scale MSC cultures for initial process validation: culture rates, phenotypes at final harvest and post-thaw parameters are reported

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