Pharmaceutically active products microorganisms

A wide variety of products can be produced by fermentation. In some cases the microorganism itself is the product, for example, in the manufacturing of active dry yeast (ADY). Well-known pharmaceutical fermentation products are insulin and penicillin G. Fermentation processes are also used to produce various commodity bioproducts like organic and amino acids, polysaccharides, lipids, chemical compounds like isoprene (Whited et al., 2010), 1,3-propanediol (Nakamura and Whited, 2003), RNA, DNA, enzymes, and other proteins. The large variety of commodity bioproducts produced by fermentation requires an equally large variety of different methods to separate and purify them. Compared to fermentation processes, where usually one unit, the fermenter vessel, is used, several different steps and unit operations are necessary to achieve purification and formulation of bioproducts. 

Metabolic and enzyme engineering have received a lot of attention in academic institutions and are now being applied for the optimization of biocatalysts used in the production of a diverse range of products. Engineered microorganisms, even with non-native enzyme activities, are being used for novel products and process improvements for the production of precursors, intermediates and complete compounds, required in the pharmaceutical industry (Chartrain et ai, 2000). 

The inclusion of the a routine microbial limit test in a marketed product stability protocol depends on the pharmaceutical dosage form. Typically, the test would be used only for nonsterile products, especially oral liquids, nasal sprays, and topical liquids, lotions, and creams that have sufficient water activity to support the growth of microorganisms. In contrast, tablets, powder- and liquid-filled capsules, topical ointments, vaginal and rectal suppositories, nonaqueous liquids and inhalation aerosols with a water activity too low to allow for the product to support the growth of microorganisms would not be routinely tested. 

Microorganisms are extremely versatile chemists. The wide variety of structures among the relatively few compounds discussed here is testimony to that. There are several theories to explain the evolutionary advantage conferred by the synthesis of secondary metabolites. (It often seems that they serve primarily to enrich pharmaceutical companies.) Until recently, the idea that they conferred a competitive advantage upon the producing organism seemed reasonable, since most of the products that had been detected had antibiotic activity. 

One way or another, the new techniques of genetic manipulation and analysis will find their way into industrial production of more efficient biologically active novel natural products from filamentous microorganisms. This process is already under way. The major pharmaceutical companies are at the forefront of progress in applying state-of-the-art techniques to strain and product development. 

---