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| Table 1. DNA removal in API-rHBsAg manufacturing process in 20 batches, 5 consecutively produced in 2000, 2001, 2003 and 2005. Results are given in pg DNA per dose of vaccine (20 µg/protein) and per µg DNA. |
|
Parameters |
DNA, pg/dose |
||||||||
|
AP |
PP |
NAE |
IAF |
DS |
PAE |
C-D |
GF |
API |
|
| Average |
5.1 |
1.7 |
70.1 |
19.4 |
13.4 |
5.5 |
2.6 |
4.2 |
3.1 |
| SD |
2.7 |
1.1 |
39.3 |
10.5 |
7.45 |
2.2 |
1.7 |
1.4 |
1.5 |
| RF |
8.7 |
8.2 |
1.9 |
1.3 |
1.1 |
0.7 |
0.4 |
0.6 |
0.5 |
| RFop |
--- |
0.5 |
6.4 |
0.6 |
0.2 |
0.4 |
0.3 |
--- |
--- |
| %Preduc. |
--- |
5.4 |
77.6 |
30.3 |
12.4 |
34.4 |
44.8 |
--- |
--- |
|
DNA, µg |
|||||||||
| Average |
15.2 |
3.1 |
88.6 |
11.3 |
10.5 |
3.8 |
1.6 |
2.4 |
2.1 |
| SD |
8.1 |
2.1 |
56.5 |
8.7 |
7.4 |
2.0 |
0.9 |
1.2 |
0.8 |
| Samples assayed were: AP: supernatant of Acid Precipitation; PP: material from primary purification; NAE: Negative Anion-Exchange chromatography; IAF: Immunoaffinity chromatography; DS: desalting gel filtration chromatography; PAE: Positive Anion-Exchange Chromatography; C-D: Concentration-Diafiltration by Tangential Flow Filtration; GF: Gel Filtration Chromatography by High Performance Liquid Chromatography; API: Active Pharmaceutical Ingredient; RF: reduction factor; RFop: reduction log for specific operation; %Preduc: reduction percentage for specific operation. |
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