Genetic engineering product applications

Data must be provided on the identity of the chemical active ingredient as well as of the contaminants (12-13) (Table I). These data requirements are sufficiently inclusive to be applicable to chemicals manufactured by biotechnological processes. It should be emphasized that different tests may be necessary to provide the data for genetically engineered products and that new tests may have to be developed to do so. Toxicity testing requirements to assess potential hazard to human health are outlined in T-1-245 (14) and are summarized in Table II. It should be noted that the technical... 

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. 

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 production of human (Cu,Zn)-SOD by genetic engineering could make sufficient amounts available for a further testing of the promising applications in auto-inunune and inflammatory diseases, and as an adjuvant in the radio- and chemotherapy of certain types of tumors. In this respect the hemolysis observed as a secondary effect in patients treated with nitrogen mustards could be ascribed to a striking reduction of the (Cu,Zn)-SOD levels in their erythrocytes... 

Many peptides are potentially useful as pharmacologic agents, and their production is of considerable commercial importance. There are three ways to obtain a peptide (1) purification from tissue, a task often made difficult by the vanishingly low concentrations of some peptides (2) genetic engineering (Chapter 9) or (3) direct chemical synthesis. Powerful techniques now make direct chemical synthesis an attractive option in many cases. In addition to commercial applications, the synthesis of specific peptide portions of larger proteins is an increasingly important tool for the study of protein structure and function. 

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