Table 1.
Open in new tab

Quality control analyses of monoclonal antibodies [mAbs]

QC testHumira-derived materialCGP-derived material
mAbHumira [mock treated]Sia-HumiraHumira-pHrodoSia-Humira-pHrodoSia-AdalimumabSia-Adalimumab pHrodo
AbbreviationFuc-G0Fuc-G2S1/G2S2Fuc-G0Fuc-G2S1/G2S2G2S1/G2S2G2S1/G2S2
Concentration [A280], mg/mL110.720.7610.7
Appearance [4°C]Colourless liquidColourless liquidClear pink colourClear pink colourColourless liquidClear pink colour
pH 666666
BufferPBSPBSPBSPBSPBSPBS
Purity, aggregation [SE-HPLC]≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥99.9% Monomer99.6% Monomern.d.
≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer≤0.1% Dimer 0.4% Dimer
N-glycan [RF-MS]77% G0F [Fuc-G0]65% G2FS2 [Fuc-G2S2]n.d.n.d.65% G2S2 n.d.
17% G1F 15% G2FS1 [FucG2S1]35% G2S1
1% G2FOthers: 20%
Others [e.g. Man5, Man6] 6%
[total: 0% Sialylated][total: >80% Sialylated][total: >99% Sialylated]
Endotoxin [LAL], EU/mg0.075<0.050.17<0.050.1 0.075
Binding affinity to TNF-alpha, ×10−10 M 1.68–1.811.81–1.92.20 ± 0.282.63 ± 0.281.65 ± 0.092.30 ± 0.22
KD [SPR]
Purity [SDS-PAGE] 99.5% [reducing]98.8% [reducing]98% [reducing]98.5% [reducing]99.9% [reducing]99.9% [reducing]
99.5% [non-reducing] 99.3% [non-reducing] 97% [non-reducing] 98.5% [non-reducing] 98.8% [non-reducing] 98% [non-reducing]
Freeze thaw, purity / aggregation≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥.9% Monomer99.4% Monomern.d.
[SE-HPLC]≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer ≤0.1% Dimer 0.6% Dimer
Degree of labellingn.a.n.a.1.782.05n.a.1.9
QC testHumira-derived materialCGP-derived material
mAbHumira [mock treated]Sia-HumiraHumira-pHrodoSia-Humira-pHrodoSia-AdalimumabSia-Adalimumab pHrodo
AbbreviationFuc-G0Fuc-G2S1/G2S2Fuc-G0Fuc-G2S1/G2S2G2S1/G2S2G2S1/G2S2
Concentration [A280], mg/mL110.720.7610.7
Appearance [4°C]Colourless liquidColourless liquidClear pink colourClear pink colourColourless liquidClear pink colour
pH 666666
BufferPBSPBSPBSPBSPBSPBS
Purity, aggregation [SE-HPLC]≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥99.9% Monomer99.6% Monomern.d.
≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer≤0.1% Dimer 0.4% Dimer
N-glycan [RF-MS]77% G0F [Fuc-G0]65% G2FS2 [Fuc-G2S2]n.d.n.d.65% G2S2 n.d.
17% G1F 15% G2FS1 [FucG2S1]35% G2S1
1% G2FOthers: 20%
Others [e.g. Man5, Man6] 6%
[total: 0% Sialylated][total: >80% Sialylated][total: >99% Sialylated]
Endotoxin [LAL], EU/mg0.075<0.050.17<0.050.1 0.075
Binding affinity to TNF-alpha, ×10−10 M 1.68–1.811.81–1.92.20 ± 0.282.63 ± 0.281.65 ± 0.092.30 ± 0.22
KD [SPR]
Purity [SDS-PAGE] 99.5% [reducing]98.8% [reducing]98% [reducing]98.5% [reducing]99.9% [reducing]99.9% [reducing]
99.5% [non-reducing] 99.3% [non-reducing] 97% [non-reducing] 98.5% [non-reducing] 98.8% [non-reducing] 98% [non-reducing]
Freeze thaw, purity / aggregation≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥.9% Monomer99.4% Monomern.d.
[SE-HPLC]≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer ≤0.1% Dimer 0.6% Dimer
Degree of labellingn.a.n.a.1.782.05n.a.1.9

n.d., not determined; n.a., not applicable.

Table 1.
Open in new tab

Quality control analyses of monoclonal antibodies [mAbs]

QC testHumira-derived materialCGP-derived material
mAbHumira [mock treated]Sia-HumiraHumira-pHrodoSia-Humira-pHrodoSia-AdalimumabSia-Adalimumab pHrodo
AbbreviationFuc-G0Fuc-G2S1/G2S2Fuc-G0Fuc-G2S1/G2S2G2S1/G2S2G2S1/G2S2
Concentration [A280], mg/mL110.720.7610.7
Appearance [4°C]Colourless liquidColourless liquidClear pink colourClear pink colourColourless liquidClear pink colour
pH 666666
BufferPBSPBSPBSPBSPBSPBS
Purity, aggregation [SE-HPLC]≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥99.9% Monomer99.6% Monomern.d.
≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer≤0.1% Dimer 0.4% Dimer
N-glycan [RF-MS]77% G0F [Fuc-G0]65% G2FS2 [Fuc-G2S2]n.d.n.d.65% G2S2 n.d.
17% G1F 15% G2FS1 [FucG2S1]35% G2S1
1% G2FOthers: 20%
Others [e.g. Man5, Man6] 6%
[total: 0% Sialylated][total: >80% Sialylated][total: >99% Sialylated]
Endotoxin [LAL], EU/mg0.075<0.050.17<0.050.1 0.075
Binding affinity to TNF-alpha, ×10−10 M 1.68–1.811.81–1.92.20 ± 0.282.63 ± 0.281.65 ± 0.092.30 ± 0.22
KD [SPR]
Purity [SDS-PAGE] 99.5% [reducing]98.8% [reducing]98% [reducing]98.5% [reducing]99.9% [reducing]99.9% [reducing]
99.5% [non-reducing] 99.3% [non-reducing] 97% [non-reducing] 98.5% [non-reducing] 98.8% [non-reducing] 98% [non-reducing]
Freeze thaw, purity / aggregation≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥.9% Monomer99.4% Monomern.d.
[SE-HPLC]≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer ≤0.1% Dimer 0.6% Dimer
Degree of labellingn.a.n.a.1.782.05n.a.1.9
QC testHumira-derived materialCGP-derived material
mAbHumira [mock treated]Sia-HumiraHumira-pHrodoSia-Humira-pHrodoSia-AdalimumabSia-Adalimumab pHrodo
AbbreviationFuc-G0Fuc-G2S1/G2S2Fuc-G0Fuc-G2S1/G2S2G2S1/G2S2G2S1/G2S2
Concentration [A280], mg/mL110.720.7610.7
Appearance [4°C]Colourless liquidColourless liquidClear pink colourClear pink colourColourless liquidClear pink colour
pH 666666
BufferPBSPBSPBSPBSPBSPBS
Purity, aggregation [SE-HPLC]≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥99.9% Monomer99.6% Monomern.d.
≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer≤0.1% Dimer 0.4% Dimer
N-glycan [RF-MS]77% G0F [Fuc-G0]65% G2FS2 [Fuc-G2S2]n.d.n.d.65% G2S2 n.d.
17% G1F 15% G2FS1 [FucG2S1]35% G2S1
1% G2FOthers: 20%
Others [e.g. Man5, Man6] 6%
[total: 0% Sialylated][total: >80% Sialylated][total: >99% Sialylated]
Endotoxin [LAL], EU/mg0.075<0.050.17<0.050.1 0.075
Binding affinity to TNF-alpha, ×10−10 M 1.68–1.811.81–1.92.20 ± 0.282.63 ± 0.281.65 ± 0.092.30 ± 0.22
KD [SPR]
Purity [SDS-PAGE] 99.5% [reducing]98.8% [reducing]98% [reducing]98.5% [reducing]99.9% [reducing]99.9% [reducing]
99.5% [non-reducing] 99.3% [non-reducing] 97% [non-reducing] 98.5% [non-reducing] 98.8% [non-reducing] 98% [non-reducing]
Freeze thaw, purity / aggregation≥99.5% Monomer≥99.5% Monomer≥99.9% Monomer≥.9% Monomer99.4% Monomern.d.
[SE-HPLC]≤0.5% Dimer ≤0.5% Dimer ≤0.1% Dimer ≤0.1% Dimer 0.6% Dimer
Degree of labellingn.a.n.a.1.782.05n.a.1.9

n.d., not determined; n.a., not applicable.

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