Quantitation of the monoclonal antibody Denosumab by bioassay and validated LC methods.
Autor: | Perobelli RF; Postgraduate Program in Pharmaceutical Sciences, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil., Xavier B; Postgraduate Program in Pharmaceutical Sciences, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil., Silveira ARD; Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil., Remuzzi GL; Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil., Motta LGJ; Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil., Dalmora SL; Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900 Santa Maria, RS, Brazil. Electronic address: sdalmora@terra.com.br. |
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Jazyk: | angličtina |
Zdroj: | International journal of biological macromolecules [Int J Biol Macromol] 2018 Nov; Vol. 119, pp. 96-104. Date of Electronic Publication: 2018 Jul 23. |
DOI: | 10.1016/j.ijbiomac.2018.07.120 |
Abstrakt: | The monoclonal antibody Denosumab (DmAb) is clinically used to treat osteoporosis and bone loss. We developed a bioassay based on the ability of DmAb to inhibit the effect of human receptor activator of nuclear factor-κB ligand (RANKL) to stimulate the formation of osteoclasts derived from RAW 264.7 cells. This bioassay was applied in conjunction with size exclusion high-performance liquid chromatography (SE-HPLC) and reversed-phase high-performance liquid chromatography (RP-HPLC) methods, with diode array detection (DAD), validated for the quantitation of this biotechnology-derived medicine. The SE-HPLC(DAD) method was carried out on a TSKGel G2000SW (Copyright © 2018 Elsevier B.V. All rights reserved.) |
Databáze: | MEDLINE |
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