A novel bioassay to assess bioactivity of PEG-rhGH using Nb2-11 cells
10.16438/j.0513-4870.2022-1107
- VernacularTitle:利用Nb2-11细胞建立PEG化重组人生长激素生物学活性测定方法
- Author:
Xiao-ming ZHANG
1
;
Ying HUANG
2
;
Lü-yin WANG
1
;
Yi LI
1
;
Jing LI
1
;
Cheng-gang LIANG
1
Author Information
1. National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, Beijing 102629, China
2. China Pharmaceutical University, Nanjing 211198, China
- Publication Type:Research Article
- Keywords:
polyethylene glycol recombinant human growth hormone;
bioactivity;
quality control;
method validation;
cell proliferation assay
- From:
Acta Pharmaceutica Sinica
2023;58(3):773-778
- CountryChina
- Language:Chinese
-
Abstract:
In this study, we established a novel bioassay to determine the activity of polyethylene glycolated recombinant human growth hormone (PEG-rhGH) using Nb2-11 cells. We performed experimental condition optimization and methodological verification, and then detected the relative potency of PEG-rhGH products using this method. We demonstrated that the bioactivity of PEG-rhGH in promoting Nb2-11 cell proliferation displays a dose-response relationship, which conformed to the four-parameter model. Using PEG-rhGH reference as a control, we analyzed the relative potency of six batches of PEG-rhGH products, as well as linearity, regression and parallelism of the obtained curves. The relative potency of six batches of PEG-rhGH products was 95% to 105%. These results implied that the new bioassay established may be employed in quality control of PEG-rhGH products.
