Table 1 Analytical data across various batches for MsAb-A and MsAb-B

UP-SEC (%Monomer)

99.0

99.4

99.3

UP-SEC (%High Molecular Weight)

0.5

0.5

0.4

iCIEF (%acidic)

23.6

24.6

26.0

iCIEF (%main)

70.8

69.4

70.0

iCIEF (%basic)

5.6

6.0

4.1

CE-SDS non reduced (%Intact IgG)

97.9

98.0

98.6

CE-SDS non reduced (%Low Molecular Weight)

2.1

2.0

1.4

Reduced CE-SDS (%HC + LC + ScFv-Fc)

98.9

99.4

99.1

Reduced CE-SDS (%total impurities)

1.1

0.6

0.9

Residual DNA (pg/mg)

< 0.406

< 0.045

< QL

Residual HCP (ng/mg)

< QL

< QL

< 0.5

Residual ProA (ng/mg)

< QL

0.809

< 0.3

pH

5.6

5.5

5.7

Binding ELISA (% relative potency)

100

100

96

FcgRIII

89

90

86

Cell-based assay (% relative potency)

98

90

86

N-glycan (G0-GlcNAc) (%area)

3.8

4.5

2.4

N-glycan (G0F-GlcNAc) (%area)

8.5

11.1

10.5

N-glycan (G0) (%area)

7.9

6.0

4.5

N-glycan (G0F) (%area)

61.6

58.5

64.2

N-glycan (Man5/G1F-GlcNAc/G1) (%area)

6.2

8.2

7.7

N-glycan (G1F) (%area)

4.4

4.1

4.5

N-glycan (G1F’) (%area)

1.9

1.8

2.2

UP-SEC (%Monomer)

99.2

98.3

98.8

UP-SEC (%High Molecular Weight)

0.7

1.3

0.9

UP-SEC (%Low Molecular Weight)

0.1

0.4

0.2

CE-SDS non reduced (%Intact IgG)

98.4

97.2

97.0

CE-SDS non reduced (%Low Molecular Weight)

1.6

1.8

1.6

Binding ELISA (% relative potency)

103

109

108