Table 2.
Therapeutic protein samples tested using the LecChip-IgG-mAb microarray.
| No. | Nonproprietary name | Proprietary name | Featured N-glycan epitope | Protein class | Expression cell lines*1 |
|---|---|---|---|---|---|
| 1 | Filgrastim | Neupogen | Nonglycosylated protein, general negative control | Cytokine | E. coli |
| 2 | Atezolizumab | Tecentriq | Nonglycosylated IgG1, IgG1 negative control | IgG1 mAb | CHO22 |
| 3 | NISTmAb | Not applicable | Well characterized N-glycosylated IgG1 mAb, a reference material widely used for analytical method development | IgG1 mAb | NS0 |
| 4 | Trastuzumab | Herceptin | Typical IgG1 produced in CHO | IgG1 mAb | CHO |
| 5 | Cetuximab | Erbitux | Unique IgG1 with 2 N-glycosylation sites on heavy chain in both the Fc and the Fab domain, contains NGNA and α-Gal glycans in its Fab region | IgG1 mAb | Sp2/023 |
| 6 | Benralizumab | Fasenra | Afucosylated, terminal GlcNAc | IgG1 mAb | CHO |
| 7 | Siltuximab | Sylvant | High mannose | IgG1 mAb | CHO |
| 8 | Ramucirumab | Cyramza | α2,6-sialylation with NGNA, α-Gal | IgG1 mAb | NS0 |
| 9 | Obinutuzumab | Gazyva | Bisecting GlcNAc, appears to contain low abundance of core fucose | IgG1 mAb | CHO |
| 10 | Darbepoetin alfa | Aranesp | Tri/tetra-antennary N-glycans, α2,3-sialylation with NANA | Cytokine | CHO |
| 11 | Infliximab | Remicade | Innovator product | IgG1 mAb | Sp2/0 |
| 12 | Infliximab-dyyb | Inflectra | Biosimilar produced in the same cell line | IgG1 mAb | Sp2/0 |
| 13 | Infliximab-abda | Renflexis | Biosimilar produced in a different cell line | IgG1 mAb | CHO24 |
| 14 | Infliximab-axxq | Avsola | Biosimilar produced in a different cell line | IgG1 mAb | CHO |
| 15 | Etanercept | Enbrel | Other type of IgG mAb with 2 N- and multiple O-glycosylation sites on the fusion-protein domain in addition to IgG1-Fc N-glycosylation, high level of β-Gal and high mannose | IgG1-Fc fusion protein | CHO |
| 16 | Ado-trastuzumab emtansine | Kadcyla | Other type of IgG mAb with typical N-glycan profile | IgG1 ADC | CHO |
| 17 | Panitumumab | Vectibix | Other type of IgG mAb with high mannose | IgG2 mAb | CHO |
| 18 | Pembrolizumab | Keytruda | Other type of IgG mAb with typical N-glycan profile | IgG4 mAb | CHO |
* E. coli, Escherichia coli; CHO, Chinese Hamster Ovary; NS0 & Sp2/0 are two murine cell lines. 1. https://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling.