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1.3.3 Therapeutic Proteins

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Proteins are the building block of our body and are essential for proper functioning of body. Any defect in a particular protein can lead to a disease such as hemophilia (lack of various blood‐clotting factors), dwarfism (lack of growth hormone), and diabetes (less or no insulin production) (Vajo et al., 2001; Takeda et al., 2010). These diseases caused by the deficiencies of the proteins can be treated by regular administration of them. These are synthesized by the other organisms, isolated, purified, and then given to patients. Proteins synthesis for human use is completely different form the enzymes used for chemical industry as for human’s quality constraints are strict and detailed clinical trials are required. More therapeutic proteins are under clinical trial than in the market.

Out of the many recombinant therapeutic proteins human growth hormones (hGH) is at the top. Its market was estimated to be $2850.70 million in 2018 and is anticipated to reach $5653.60 million by 2026 observing a CAGR of 8.2% over the estimated period. Two of the most common hGh currently in the market are Accretropin™ and Sermorelin (Reh and Geffner, 2010). Accretropin™ (recombinant human growth hormone (r‐hGH); somatropin) is a protein, which is manufactured by rDT. The production process includes fermentation of E. coli that gives a protein product containing 192 amino acids. Later process includes removal of the N‐terminal amino acid, methionine that yields a product which is physio‐chemically and chemically similar to pituitary‐derived hGH, comprising of 191 amino acids. These are arranged in a single polypeptide chain. In general terms, Accretropin vitalize linear growth in those patients whose body lacks sufficient production of the endogenous growth hormones. Other than that, it also shows substantial effect in process such as tissue growth, metabolism of protein, carbohydrate, and lipids along with minerals. The drug got approved by FDA on 23 January 2018. It is manufactured by Cangene Corporation, Canada.

Similarly, Sermorelin or growth hormone releasing factor 1‐29 NH2‐acetate is classified as a member of the growth hormone‐releasing hormone analogue class drug. It is made up of 29 amino acids out of the 44 that originate in its natural state (Walker, 2006). It can notably increase the release of the growth hormone in the body. It also aims to enhance growth hormone serum concentrations and insulin‐like growth factor 1 (IGF‐1). The bodies of those children, which does not produce enough growth hormone, can be provided with Sermorelin to assist with the increase in amount of growth hormone processed by the pituitary gland. Other than that, it is also commonly prescribed for the treatment of adult growth hormone deficiency. It is also getting popular with those doctors who use them partly in their medical weight loss plans. The drug was first developed during early 1980s and was approved by the FDA by 1997 for sale via prescription.

Another fine example is IGF‐1 (Laron, 2001). They can be related to the family of insulin‐related peptides, which comprise of relaxin and various other peptides, which are extracted from lower invertebrates. Being a small peptide and comprising of 70 amino acids and with a molecular weight of 7469 Da, it binds to the insulin receptor with a relatively low affinity. Along with IGF‐2, they were first found in 1957 by Salmon and Daughday. The IGF‐1 plays major role in proliferation and function of just about every cell, tissue, and organ in the body. Their action mechanism conciliates through IGF/IGFR binding, the activation of kinase, and signaling via AKT pathway.

Biomolecular Engineering Solutions for Renewable Specialty Chemicals

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