Comprehensive Monograph on Somatropin (Recombinant Human Growth Hormone)

Section 1: Introduction to Somatropin: A Recombinant Peptide Hormone

Somatropin, the pharmacologic designation for recombinant human growth hormone (hGH), represents a cornerstone of modern endocrinology. It is a potent peptide hormone that governs fundamental processes of somatic growth, cell reproduction, and metabolism. Its journey from a scarce, high-risk biological extract to a precisely engineered and widely accessible therapeutic agent encapsulates a significant chapter in the history of medicine and biotechnology. As a therapeutic agent, its core principle is the replacement of deficient endogenous hormone or the pharmacological supplementation to achieve specific clinical outcomes in growth and metabolic disorders.[1]

1.1 Historical Context: From Pituitary Extraction to Recombinant DNA Technology

The therapeutic application of growth hormone began in the 1950s with the challenging and precarious process of extracting the hormone from the pituitary glands of human cadavers.[3] This early form of treatment, while providing the first hope for children with severe growth hormone deficiency (GHD), was fraught with limitations, including scarcity of supply and significant safety concerns. The most devastating of these risks was the iatrogenic transmission of Creutzfeldt-Jakob disease (CJD), a fatal prion-induced neurodegenerative disorder.[4] The realization that contaminated batches of pituitary-derived GH could transmit this incurable disease created an urgent and profound unmet medical need for a safer alternative.