Penicillins, development quality

Another example from the "bio-world" is the production of micro-organisms for optimum product yield and quality. An example could be micro-organisms for the production of penicillin, whereas recently there have been developments to explore routes to produce monomers for synthetic polymers by means of micro-organisms. Diversity in the micro-organisms to be tested can be achieved either by genetic engineering or by random mutagenesis. 

Identification Quality Assessment. In a first of its kind paper, Rose in 1982 showed that a number of structurally similar penicillin-type drugs could be identified and determined by NIR. At Sandoz, Ciurczak in 1984 reported using Mahalanobis distance-based algorithms for the identification of raw materials. ° Ciurczak also reported the use of spectral matching (SM) and principle component analysis (PCA) for raw materials and suggested a method for introducing variations into samples for more robust equation development in 1986. NIR has been in use for raw material ID since then in companies worldwide. 

Penicillin proved a difficult compound to isolate and purify. Although Fleming recognized the antibiotic qualities of penicillin and its remarkable non-toxic nature to man, he disregarded it as a useful drug since it appeared too unstable. He could isolate it in solution, but whenever he tried to remove the solvent, the drug was destroyed. Now that we know the structure of penicillin (Chapter 9), its instability under the purification procedures of the day is understandable and it was not until the development of a new procedure called freeze-drying that a successful isolation of penicillin was achieved. 

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