Table 3.

Gene-modified cell characteristics

ControlExpected valueObserved values, medianObserved values, range
Transduction efficiency before G418 selection, % — 8.3 1.5 -19.7 
Viability after thawing, % > 60 77.4 60 -92  
Ratio, GMC/PBMC input — 6.1 1.5 -15.4  
GCV inhibition, % > 80 87 80 -93  
CD3+ cells, % > 50 90.5 71.4 -97.2 
ControlExpected valueObserved values, medianObserved values, range
Transduction efficiency before G418 selection, % — 8.3 1.5 -19.7 
Viability after thawing, % > 60 77.4 60 -92  
Ratio, GMC/PBMC input — 6.1 1.5 -15.4  
GCV inhibition, % > 80 87 80 -93  
CD3+ cells, % > 50 90.5 71.4 -97.2 

The expected value indicates the quality control criteria.

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