A novel bioassay to assess bioactivity of PEG-rhGH using Nb2-11 cells / 药学学报
Acta Pharmaceutica Sinica
; (12): 773-778, 2023.
Article
in Zh
| WPRIM
| ID: wpr-965638
Responsible library:
WPRO
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.
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WPRIM
Language:
Zh
Journal:
Acta Pharmaceutica Sinica
Year:
2023
Type:
Article