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Table 1 LAL test: list of samples analyzed

From: Validation of analytical methods in compliance with good manufacturing practice: a practical approach

Sample number

Samples

1

PYROGEN-FREE WATER

2

SN + 10%FBS 1:10

3

SN + 10%FBS 1:50

4

SN + 10%FBS 1:80

5

SN + 10%FBS THAWED 1: 10

6

SN + 10%FBS THAWED 1:50

7

SN + 10%FBS THAWED 1:80

8

SN + 10%FBS HEATED 1:10

9

SN + 10%FBS HEATED 1:50

10

SN + 10%FBS HEATED 1:80

11

FS + 5%ALBUMIN 1:10

12

FS + 5%ALBUMIN 1:50

13

FS + 5%ALBUMIN 1:80

14

BM MSCs 1X103 cells/ml

15

BM MSCs 1X102 cells/ml

16

CTLs 1X103 cells/ml

17

CTLs 1X102 cells/ml

18

SN + 5%HS 1:10

19

SN + 5%HS 1:50

20

SN + 5%HS 1:80

21

SN + 5%HS THAWED 1:10

22

SN + 5%HS THAWED 1:50

23

SN + 5%HS THAWED 1:80

  1. The test was performed on supernatant at different dilutions, on CTPs at different concentrations, and on pyrogen-free water as negative control.
  2. Abbreviations: SN supernatant, FBS fetal bovine serum, FS saline, HS human serum.