Genetically engineered therapeutic proteins

Bioseparations are essential in the manufacture of high-volume, low-value bulk pharmaceuticals and nutraceuticals such as antibiotics and vitamins, where economies of scale are used to ensure commercial competitiveness. At the opposite end of the pharmaceutical product spectrum, genetically engineered therapeutic proteins of extremely high value are produced at very small scale. 

Biomedical Applications. TRIS AMINO is used for a number of purposes in its pure form, it is an acidimetric standard the USP grade can be utilized intraveneously for therapeutic control of blood acidosis TRIS AMINO also is useful in genetic engineering as a buffering agent for enzyme systems, industrial protein purification, and electrophoresis. AMP has found use as a reagent in enzyme-linked immunoassays. The primary appHcation is for alkaline phosphatase assays. 

The biopharmaceutical sector is largely based upon the application of techniques of molecular biology and genetic engineering for the manipulation and production of therapeutic macromolecules. The majority of approved biopharmaceuticals (described from Chapter 8 onwards) are proteins produced in engineered cell lines by recombinant means. Examples include the production of insulin in recombinant E. coli and recombinant S. cerevisiae, as well as the production of EPO in an engineered (Chinese hamster ovary) animal cell line. 

Therapeutic gold complexes, 12 700-701 Therapeutic index, 18 252 Therapeutic pet foods, 10 849 Therapeutic products, from genetically engineered microbes, 12 480 Therapeutic proteins, 3 816 Therapeutics, supramolecular chemistry in, 24 56-57... 

A number of clinical circumstances have been identified which are characterized by an often profoundly depressed rate of erythropoiesis (Table 6.7). Many, if not all, such conditions could be/are responsive to administration of exogenous EPO. The prevalence of anaemia, and the medical complications which ensue, prompts tremendous therapeutic interest in this haemopoietic growth factor. EPO has been approved for use to treat various forms of anaemia (Table 6.8). It was the first therapeutic protein produced by genetic engineering, whose annual sales value topped 1 billion. Its current annual sales value is now close to 2 billion. EPO used therapeutically is produced by recombinant means in CHO cells. 

Table 9.1. Major blood products that find therapeutic application. While all of these products are still sourced from human blood donations, a number of the protein-based products are now also produced by genetic engineering. Antibody preparations are considered in the next chapter...

The approval of genetically engineered version of human DNAase, which breaks down protein accumulation in the lungs of CF patients. It was the first new therapeutic drug for the management of cystic fibrosis in over 30 years... 

---