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Table 5 Robustness of incubation steps

From: A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody

Screening assay

 

Batch 30 plate 1

Batch 30 plate 2

Block

25 min

30 min

35 min

30 min

30 min

30 min

30 min

30 min

MM

180 min

180 min

180 min

170 min

190 min

180 min

180 min

180 min

Sample

60 min

60 min

60 min

60 min

60 min

50 min

60 min

70 min

 

Mean ECL

% Diff

Baseline mean ECL

Mean ECL

% Diff

Mean ECL

% Diff

Mean ECL

% Diff

Mean ECL

% Diff

Baseline mean ECL

Mean ECL

% Diff

HPC

146021

2.3

142677

146095

2.4

142399

−0.2

148013

3.7

180810

1.4

178324

180245

−1.1

MPC

2869

1.1

2839

2847

0.3

2805

−1.2

2848

0.3

3630

−2.4

3718

3670

1.3

LPCa

341

1.9

334

339

1.5

336

0.4

337

0.9

400

1.1

395

396

−0.3

NC

106

6.6

99

103

3.5

105

6.1

102

3.0

104

4.0

100

103

−2.9

NC

109

−0.5

109

111

1.4

115

5.5

109

0.0

110

−3.9

115

111

3.2

NC

101

−1.5

103

100

−2.4

103

0.0

101

−2.0

101

−1.0

102

103

−1.5

NC

111

1.4

109

107

−2.3

110

0.9

108

−0.9

111

−0.9

112

111

0.9

NC

105

1.0

104

102

−2.4

106

1.4

100

−3.8

103

−1.9

105

107

−1.9

Confirmatory assay

 

Batch 31 plate 1

Batch 31 plate 2

Block

30 min

30 min

30 min

30 min

30 min

SGP

65 min

60 min

55 min

60 min

MM

180 min

177 min

187 min

180 min

180 min

MM

180 min

180 min

180 min

180 min

Drug

60 min

60 min

60 min

57 min

65 min

Drug

60 min

60 min

60 min

60 min

 

Mean ECL

  
 

No drug

With drugs

Mean ECL

% Diff

Mean ECL

% Diff

Mean ECL

% Diff

Mean ECL

% Diff

 

Mean ECL

% Diff

BL mean ECL

Mean ECL

% Diff

Mean ECL no drug

HCP

136898

135

134

−0.7

134

−1.1

134

−0.7

135

−0.4

 

125

1.6

123

122

−1.2

144616

MPC

2898

90

88

−2.8

89

−1.1

90

0.0

91

1.1

 

85

3.00

83

82

−0.6

2947

LPCa

363

98

94

−4.1

94

−3.6

97

−0.5

96

−1.5

 

92

4.5

88

90

2.3

340

NC

110

91

86

−5.5

87

−4.9

91

−0.5

90

−1.1

 

83

0.6

83

81

−1.8

103

NC

116

97

95

−1.6

95

−1.6

96

−0.5

99

2.6

 

92

1.7

91

91

0.6

114

NC

109

91

90

−1.6

90

−1.1

92

1.1

95

3.8

 

85

3.7

82

85

3.7

104

NC

117

98

97

−1.5

98

0.0

100

1.5

103

5.1

 

93

1.6

91

94

2.7

111

NC

110

97

89

−7.8

91

−5.7

95

−2.1

95

−1.6

 

87

3.0

85

86

1.2

106

  1. aLPC concentration is 40 ng/mL