Table 2. Performance comparison between manufacturing scale and small-scale data for immunoaffinity chromatography and positive anion-exchange chromatography.

Parameters

Immunoaffinity chromatography

Positive anion-exchange chromatography

Starting
material

Manufacturing
scale
n = 5

Small scale
n = 5

Starting
material

Manufacturing
scale
n = 5

Small scale
n = 5

Yield (%)

---

> 50*

72.1 ± 2.8

---

> 70*

81.5 ± 5.4

Purity (%)

41±3

> 80*

87 ± 3

89 ± 1

96 ± 1

95 ± 2

IgG (%)

---

0.4 ± 0.2

0.6 ± 0.1

0.21 ± 0.07

0.14 ± 0.05

0. 08 ± 0.02

Carboh.

(µg/dose)

568.9 ± 94.4

10.5 ± 5.6

4.5 ± 1.0

9.4 ± 0.6

3.4 ± 0.4

3.3 ± 0.2

Lipid

(µg/dose)

534.2 ± 71.6

18.9 ± 5.2

24.1 ± 2.4

19.7 ± 3.4

18.1 ± 5.8

12.9 ± 1.8

DNA

(pg/dose)

70.1 ± 39.3**

19.4 ± 10.5**

12.4 ± 1.9

13.4 ± 7.3**

5.5 ± 2.2**

4.8 ± 1.1