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Table 2 Results of the validation assay

From: A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice

 

1:10 DILUTION

1:100 DILUTION

 

1 st run

2 nd run

3 rd run

1 st run

2 nd run

3 rd run

Spike recovery (PPC)

122

119

121

115

76

95

143

178

176

163

142

183

PPC CV (%)

14.1

18.7

15.8

4.0

7.3

8.0

15.0

2.7

0.7

7.2

7.4

9.6

Sample CV

3.5

1.5

0

0

0

0

0

0

0

0

0

0

Sample result (EU/mL)

<0.532

<.513

<0.500

<0.500

<0.500

<0.500

<0.500

<0.500

<0.500

<0.500

<0.500

<0.500

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Journal of Translational Medicine

ISSN: 1479-5876

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