|
| Table 3. Mass balance in DNA clearance studies for immunoaffinity and ion-exchange chromatography. |
|
Immunoaffinity Chromatography |
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|
Fraction tested |
DNA per fraction mg |
DNA pg/dose |
RF |
Clearance |
| Starting material |
16.2 ± 4.5 |
(2.2 ± 0.5) x 107 |
7.3 ± 0.1 |
7.3 ± 01 |
| Pass/Wash |
18.8 ± 2.9 |
(15 ± 6) x 107 |
8.1 ± 0.2 |
|
| Elution |
(6.2 ± 0.2) x 10-5 |
1.1 ± 0.0 |
< 0.1 |
|
| Regeneration |
(1.3 ± 0.1) x 10-5 |
n.c |
< 0.1 |
|
|
Positive Anion-Exchange Chromatography |
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| Starting material |
1.0 ± 0.1 |
(1.1 ± 0.1) x 106 |
6.0 ± 0.0 |
5.8 ± 0.2 |
| Pass/Wash |
(1.9 ± 0.9)x10-6 |
n.c |
n.c |
|
| Elution |
(1.3 ± 0.2)x10-6 |
1.8 ± 0.3 |
0.2 ± 0.1 |
|
| Regeneration |
1.2 ± 0.8 |
n.c |
n.c |
|
| n.c: no calculated. Average and standard deviation values are reported for six chromatographic runs. |
|
|