Drug, sources fermentation

In addition to chemical-based drugs, a range of pharmaceutical substances (e.g. hormones and blood products) are produced by/extracted from biological sources. Such products, some major examples of which are listed in Table 1.2, may thus be described as products of biotechnology. In some instances, categorizing pharmaceuticals as products of biotechnology or chemical synthesis becomes somewhat artificial. For example, certain semi-synthetic antibiotics are produced by chemical modification of natural antibiotics produced by fermentation technology. 

In the same vein, does the company want to isolate a small molecule or macromolecule from fermentation sources, plants, or blood plasma to develop as a drug ... 

Traditionally, medicinal lead structures have originated from plant, microbial fermentation, and animal sources. Most new drug candidates today are identified through four approaches ... 

Although it may not always be possible to control the sources or extraction conditions to produce only a single component, they should be arranged so as to produce, as far as possible, a consistent mixture. Impurity profiles of botanical products are often monitored by a number of anal3hical procedures to ensure product quality. Minor components that have pharmacological activity should not necessarily be viewed as impurities. In some cases, the activity of a botanical or fermentation drug substance may be attributed to a number of components. 

Table 1.2, adapted from Paesen etal.[, shows the varying amounts of some major impurities in the fermentation drug substance erythromycin from seven sources. The major components that make up the drug substance are identified. Note that the level of water also varies quite widely. 

There are five basic sources of pharmaceuticals. By dollar value of products, fermentation is probably the most important, whereas by tonnage, chemical synthesis is dominant. Fermentation is used for antibiotics such as penicillins and tetracyclines. Chemical synthesis provides drugs such as the psychotropics and antihistamines. Animal extracts provide hormones. Biological sources lead to vaccines and serums. Vegetable extracts provide steroids and alkaloids. The top ten pharmaceutical companies in order of revenues are the following Merck, Pfizer, Bristol-Myers Squibb, Johnson ... 

Some steroid drugs are produced by total synthesis, but, in general, the ability of microorganisms to biotransform steroid substrates has proved invaluable in exploiting inexpensive natural steroids as sources of drug materials. It is now possible via microbial fermentation to hydroxylate the steroid nucleus at virtually any position and with defined stereochemistry. These... 

The correct choice = E. Tamoxifen forms a complex with the estrogen receptor. Procarbazine inhibits monoamine oxidase, an enzyme required to metabolize tyramine found in fermentative sources, such as cheese and some wines. X-irradiation is effective in eradicating leukemic cells which have found sanctuary in the CNS. Many anticancer drugs are mutagenic and carcinogenic, particularly the alkylating agents. 

Similar information is needed for the preparation, isolation and purification of antibiotics and other drug substances isolated from microbial or cell culture sources. The components of the fermentation media should be defined and specifications established, including, if applicable, a defined degree of purity. The role of each ingredient, if known, should be stated. 

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