Full
Outline
To establish an indirect enzyme-linked immunosorbent assay (ELISA) for determination of MBS77E, a novel monoclonal antibody against Ebola virus, in the serum of cynomolgus monkeys and to study its pharmacokinetics in monkeys.
An indirect ELISA method for quantitative detection of MBS77E in cynomolgus monkey serum was developed and fully validated. Four cynomolgus monkeys were divided into two groups. Each group of monkeys were administered with MBS77E via intravenous injection at dosage of 5 or 100 mg·kg-1, respectively. Blood samples were collected at different time points after administration. Serum was obtained and the concentration of MBS77E was determined using the established ELISA method. The pharmacokinetic parameters of MBS77E were analyzed using WinNonlin software.
The linear range of the method was 0.098~12.5 μg·mL-1. The precision RSDs of the intra- and inter-assay were within 3.5%~9.9% and 7.4%~11.8%, respectively. After i.v. injection at dosage of 5 and 100 mg·kg-1, the terminal t1/2 of MBS77E was (8.88±5.24) and (6.38±2.57) d, CL was (7.55±1.48) and (6.22±0.99) mL·h-1·kg-1, V was (91.18±38.16) and (55.44±14.01) mL·kg-1, AUC was (631.58±76.75) and (16 004.13±2 230.73) μg·d·mL-1, respectively. The AUCs were proportional to the two dosages. The plasma clearances of MBS77E did not change with different dosages.
An indirect ELISA method was successfully established for the determination of MBS77E in monkey serum which met the requirements of preclinical pharmacokinetic research in terms of specificity, linear range, precision and stability et al. The pharmacokinetic characteristics of MBS77E in cynomolgus monkeys were obtained. This study provided support for the preclinical and clinical pharmacokinetic studies of MBS77E.
35
11
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62662699(Operation and Technical Support)
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
