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A novel bioassay to assess bioactivity of PEG-rhGH using Nb2-11 cells
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Xiao-ming ZHANG1, Ying HUANG2, Lü-yin WANG1, Yi LI1, Jing LI1, *, Cheng-gang LIANG1, *
Acta Pharmaceutica Sinica | 2023, 58(3) : 773 - 778
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Acta Pharmaceutica Sinica | 2023, 58(3): 773-778
• Original Articles •
A novel bioassay to assess bioactivity of PEG-rhGH using Nb2-11 cells
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Xiao-ming ZHANG1, Ying HUANG2, Lü-yin WANG1, Yi LI1, Jing LI1, *, Cheng-gang LIANG1, *
Affiliations
  • 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
Published: 2023-03-12 doi: 10.16438/j.0513-4870.2022-1107
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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.

polyethylene glycol recombinant human growth hormone  /  bioactivity  /  quality control  /  method validation  /  cell proliferation assay
Xiao-ming ZHANG, Ying HUANG, Lü-yin WANG, Yi LI, Jing LI, Cheng-gang LIANG. A novel bioassay to assess bioactivity of PEG-rhGH using Nb2-11 cells[J]. Acta Pharmaceutica Sinica, 2023 , 58 (3) : 773 -778 . DOI: 10.16438/j.0513-4870.2022-1107
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Year 2023 volume 58 Issue 3
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Article Info
doi: 10.16438/j.0513-4870.2022-1107
  • Receive Date：2022-10-12
  • Online Date：2025-11-21
  • Published：2023-03-12
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History
  • Received：2022-10-12
  • Revised：2023-01-27
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Affiliations
    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
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表12种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
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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
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