Recombinant Human Growth Hormone (rhGH) is a well-established biopharmaceutical widely used in the treatment of growth hormone deficiency and related disorders. As global demand for biologics continues to rise, rhGH remains a key product in both innovator and biosimilar markets.For pharmaceutical manufacturers, sourcing high-quality rhGH API is critical to ensuring product efficacy, safety, and regulatory compliance.
Product Description
rhGH is a 191-amino-acid polypeptide hormone produced recombinant DNA technology. It is structurally identical (or highly comparable) to endogenous human growth hormone.
Key Characteristics:
Molecular formula: C₉₉₀H₁₅₂₈N₂₆₂O₃₀₀S₇ (reference)
Molecular weight: ~22 kDa
Expression system: E. coli (commonly used) or mammalian cells
High biological activity comparable to reference listed drugs
Manufacturing Capabilities
Manufacturing Process:
Gene cloning and strain developmentFermentation (upstream processing)
Inclusion body isolation (for E. coli systems)
Refolding and purification
Chromatographic separation
Sterile filtration and lyophilization
Advanced biotechnology platforms and strict process control.
Quality and Compliance
This is a titleCritical Quality Attributes (CQAs)
Regulatory Considerations
Purity (typically ≥98%)
Related proteins and aggregates
Host cell protein (HCP) and DNA residues
Endotoxin levels
Biological potency (IU/mg)
Compliance with ICH guidelines
Support for DMF/ASMF documentation
Alignment with USP/EP/ChP
pharmacopeia standards
Capability to support audits and regulatory inspections