Monoclonal Antibody System Suitability Standard

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USP Reference Standards kit

Now Available

USP mAb System Suitability RS
Molecular weight ~150 kDa

Vial contains:
2mg of IgG lyophilized monoclonal antibody

Order# 1445550

Download the PDF and get to know the USP Biologics process

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Build consistency and reproducibility into your analytical methods. A common analytical challenge associated with monoclonal antibody products is ascertaining if a specific method can resolve relevant product variants.

The USP monoclonal IgG system suitability standard was developed to address this issue by using a variety of analytical methods confirmed in an international round robin study, and extensive characterization of a monoclonal antibody material at six collaborative labs. 

USP monoclonal antibody reference standards (mAb RS) are recombinant humanized IgG1 that were expressed in Chinese hamster ovary (CHO) cell culture and have undergone industry standard upstream and downstream purification. USP mAb RS come in 3 molecular weights, each containing two identical light chains and two identical heavy chains linked through inter- and intra-chain disulfide bonds. The post-translational modifications include deamidation, methionine oxidation, tryptophan oxidation, N-terminal pyroglutamate, C-terminal lysine deletion, and N-glycosylation. 

These reference standards can be used as an independent control material for method development, training, method transfer, and internal assay control support, standardization of physico-chemical testing, such as intact mass, charge heterogeneity, size variants, purity, and glycan analyses.


Coming Soon

 
USP mAb 001 RS 
Molecular weight ~148 kDa

Vial contains:
200 µL of 10 mg/mL IgG1 tCitrate, 0.90%(w/v) Sodium Chloride, 0.07%(v/v) Polysorbate 80, pH 6.5.

 

 
USP mAb 002 RS 
Molecular weight ~150 kDa

Vial contains:
200 µL of 10 mg/mL IgG1 monoclonal antibody in 0.58% Monobasic sodium phosphate monohydrate, 0.12% Dibasic sodium phosphate anhydrous, 6% α, α-trehalose dihydrate , 0.04% Polysorbate 20,  pH 6.2

 

 
USP mAb 003 RS 
Molecular weight ~146 kDa

Vial contains:
200 µL of 10 mg/mL IgG1 monoclonal antibody in 20 mM Histidine HCl, 120 mM Sucrose, 0.02% Polysorbate 20, pH 6.0