Somatropin, also known as recombinant human growth hormone (rhGH), has the same function as human growth hormone (hGH, somatotrophin), which plays a key role in human growth and development – promotes growth of gut and bones, promotes protein synthesis, influences fat and mineral metabolism. Prior to the use of recombinant DNA technology since 1984, hGH preparations for research and treatment were prepared by extraction and purification from cadaveric pituitary tissue. Development of rDNA technology allows the large-scale manufacturing and use in clinical treatment of somatropin, which works as a hormone replacement agent by increasing the flow of water, electrolytes, and nutrients into the bowels. Somatropin is used as a prescription drug to treat dwarfism and growth failure, hGH stimulates skeletal growth in pediatric patients with growth failure due to deficiency or absent of endogenous growth hormone.
Somatropin is generally produced in recombinant Escherichia coli. Structural variants of somatropin may arise due to mis-incorporation during the transcription, translation or post translation stages (such as cysteine bridges variant, norleucine variant, etc.). Degradation (such as deamidation, oxidation, cleavege by enzymes, etc.) and aggregation may also occur during the fermentation and purification processes or during storage of the protein. These may all have influence on the biological activity of the hormone – some may have similar or even stronger biological activity to the original somatropin, while some may fail to have the expect function. Thus, detecting and quantifying the structural variants and studying the characteristics become quite necessary in the research and manufacturing. Bioassays, polyclonal antibody technology, enzymatic technology and physico-chemical methods including high-performance liquid chromatography (HPLC) and high-performance capillary electrophoresis (HPCE) are all commonly used methods.
Creative Biogene is the premier institution offering professional and comprehensive somatropin production services. We have years of experience to add value to your research and manufacturing. Like any other recombinant protein production services, we offer the full service of manufacturing somatropin with advanced genetic tools and fermentation techniques. The somatropin gene is reverse-transcribed from the mRNA found in pituitary glands before inserting into plasmid. Then the recombinant plasmids are transferred into bacteria, in most cases, Escherichia coli. After the construction of strains, the optimization of fermentation condition will be performed to ensure quality and productivity of the production. Drug licensing regulations require that recombinant proteins are extensively characterized by physico-chemical and/or biological methods. Thus, manufacturing and controlling of highly purified somatropin products become particularly important. For that purpose, we also offer advanced and comprehensive detecting and purifying services using chromatographic, electrophoretic, spectroscopic and enzymatic technologies, in order to detect and quantify even minor structural variations of the somatropin molecules.
Creative Biogene dedicates in providing the best schemes to meet your requirements. If there is any need of yours, do not hesitate to contact us!
See also:
Techniques used in recombinant pharmaceutical protein
• E.coli Expression System
• E.coli Genome Editing
Strain for recombinant pharmaceutical protein production
• E.coli Strain
For research use only.