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Table 1 Validation of the DNA extraction process

From: Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)

A)

DNA concentrations and the resulting intra-assay variation between three different DNA extractions from a single skin lysate in the same run. “Eluate 1–3” are different extractions using three different Maxwell cartridges within one run. The values were determined in triplicate (assay 1–3 at three different days)

 

  DNA concentration [ng/μl]

Intra-assay variability [%]

 

Eluate 1

Eluate 2

Eluate 3

Mean

SD

 

Assay 1

219.0

231.6

223.8

224.8

6.36

2.83

Assay 2

219.7

234.7

219.8

224.7

8.63

3.84

Assay 3

219.9

225.8

217.7

221.1

4.19

1.89

Mean

 

2.85

SD

 

0.8

B)

Mean DNA concentrations of the validation runs at three different days (assay 1–3) and resulting inter-assay variation.

 

  DNA concentration [ng/μl]

Inter-assay variability [%]

 

Assay 1

Assay 2

Assay 3

Mean

SD

 
 

224.8

224.7

221.1

223.5

2.10

0.94