TABLE 3.
Approved Fc-fusion proteins.
| International non-proprietary name | Brand name | Protein | Treatment | Company | CTS | Stationary phase | Approval year | References |
|---|---|---|---|---|---|---|---|---|
| Etanercept | Enbrel® | p75 TNF receptor (ED) | Rheumatoid arthritis, autoimmune and inflammatory diseases | Boehringer/Pfizer | AF-IEX-NA | NA | 1998 | Hassett et al. (2018); Mohler et al. (1993) |
| Abatacept | Orencia® | CTLA-4 (ED) | Rheumatoid arthritis | Lonza/Bristol-Myers | AF-NA-NA-NA | NA | 2005 | Linsley et al. (1998) |
| Rilonacept | Arcalyst® | IL-1R accessory protein | Cryopyrin-associated periodic syndromes | Regeneron Pharmaceuticals | AF-SEC | NA | 2008 | Economides et al. (2003) |
| Romiplostim | NPlate® | Thrombopoietin receptor agonist | Thrombocytopenia in chronic immune thrombocytopenic purpura patients | Amgen/Pfizer | CEX- CEX | SP Sepharose FF-SP Sepharose HP | 2008 | Liu et al. (2017) |
| Aflibercept | Eylea® | VEGF receptors 1 and 2 (BD) | Wet age-related macular degeneration, diabetic macular edema | Regeneron Pharmaceuticals | AF-CEX- AEX-HIC | NA | 2011 | Assadourian et al. (2014) |
| Belatacept | Nulojix® | CTLA-4 (ED) | Organ rejection | Bristol-Myers | AF-AEX-HIC | MabSelect Protein A, Q Sepharose FF, Toyopearl Phenyl 650M | 2011 | Leister et al. (2010) |
| Alefacept | Amevive® | LFA-3 (ED) | Psoriasis and organ rejection | Astellas Pharma | AF-SEC | Protein A-Sepharose 4B, Superose 12 | 2011 | Miller et al. (1993); Wallner et al. (1999) |
| Ziv-aflibercept | Zaltrap® | VEGF receptors 1 and 2 (BD) | Metastatic colorectal cancer | Regeneron Pharmaceuticals | AF-CEX-AEX-HIC | NA | 2012 | Assadourian et al. (2014) |
| Efmoroctocog alfa | Eloctate® | Coagulation factor VIII (B-domain deleted) | Hemophilia A | Biogen | AF-AEX- HIC | VIIISelect, Fractogel EMD TMAE Hicap, Octyl Sepharose 4 FF | 2014 | Dumont et al. (2012); McCue et al. (2015) |
| Eftrenonacog alfa | Alprolix® | Coagulation factor IX | Hemophilia B | Biogen | AF-AEX- AEX | MabSelect SuRe, Fractogel DEAE, Q Sepharose | 2014 | McCue et al. (2014); Peters et al. (2010) |
| Dulaglutide | Trulicity® | GLP-1 receptor agonist | Glycemic control in type 2 diabetes mellitus | Eli Lilly and Co. | AF-SEC | Protein A Sepharose HP, Superdex 200 | 2014 | Glaesner et al. (2010) |
| Luspatercept-aamt | Reblozyl® | Activin receptor Type IIB (Modified ED) | Anemia in adult with beta thalassemia | Celgene Corp/Acceleron Pharma Inc. | AF-AEX | MabSelect SuRe, Q-Sepharose | 2019 | Sako et al. (2010) |
AEX, anion exchange chromatography; AF, affinity chromatography; BD, binding domain; CEX, cation exchange chromatography; CTLA-4, cytotoxic lymphocyte-associated antigen 4; CTS, chromatographic techniques sequence; ED, extracellular domain; GLP-1, glucagon-like peptide-1; HIC, hydrophobic interaction chromatography; IL-1, interleukin-1; LFA-3, leukocyte function antigen-3; NA, information not available; SEC, size exclusion chromatography; TNF, tumor necrosis factor; VEGF, vascular endothelial growth factor.