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Assays for human growth hormones.

¹National Institute for Biological Standards and Control Blanche Lane, Potters Bar, Herts, UK.

Journal of Pharmaceutical and Biomedical Analysis

|January 1, 1989

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The in vivo bioassay is the standard for human growth hormone (hGH) assessment, reflecting its complex biological activity despite limitations. Physicochemical tests are suitable for quality control when linked to reliable in vivo bioassay results.

Area of Science:

Endocrinology
Biotechnology

Background:

Human growth hormone (hGH) is primarily defined by its in vivo bioactivity, measured through bioassays.
Established bioassays, like the rat weight gain assay, reflect hGH's complex in vivo actions, including metabolism and secondary hormone effects.

Purpose of the Study:

To evaluate the suitability of different assays for assessing human growth hormone.
To compare the relevance of in vivo bioassays versus in vitro methods for measuring hGH activity.

Main Methods:

In vivo bioassays measuring body weight gain in hypophysectomized rats.
In vivo tibial epiphysis bioassay measuring bone elongation.
Comparison with in vitro receptor assays and immunoassays.

Main Results:

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In vivo bioassays, despite limitations in sensitivity and precision, are the only practical methods reflecting the full spectrum of hGH's in vivo properties.
In vitro assays do not accurately represent the biological action of hGH due to potential alterations in receptor molecules and lack of in vivo relevance.
A 1984 collaborative study highlighted significant discrepancies between different hGH assay methods.

Conclusions:

In vivo bioassays remain essential for defining and assessing human growth hormone activity.
Physicochemical tests can be used for quality control of recombinant human growth hormone (somatotropin) if results correlate with in vivo bioassay outcomes.
Standardization and international reference materials are crucial for reliable hGH testing and quality control.