Enzymes for In Vitro Diagnostics Q&A
Answered January 23rd, 2012 by Expert:
Today’s diagnostic reagents use a wide range of both naturally derived and recombinant enzymes. In many cases the available natural enzymes provide appropriate performance at a reasonable cost, however where there is no natural enzyme readily available, or its performance is inadequate, then a recombinant enzyme is required. The majority of natural enzymes already employed in diagnostic reagents have well managed supply chains and are manufactured to produce consistent performance from lot to lot, so it is unlikely that they would be need to be replaced by recombinant enzymes. The use of recombinant enzymes is likely to increase therefore, due to the demand for 1/ particular improved performance criteria in existing reagents or 2/ the measurement of new analytes requiring the development of novel enzymes.
The pricing of today’s recombinant enzymes is largely driven by the scale of the fermentation hence if the demand volumes increase then there should be a concomitant decrease in pricing. Aside from volume, technical advances such as optimised vectors producing increased expression levels, greater control of protein folding and glycosylation levels, and the secretion or compartmentalising of functional enzymes to make harvesting easier should all combine to drive down the costs of production. However enzyme manufacturers will have to account for substantial research & development costs to overcome such technical hurdles so while a significant reduction in the pricing of recombinant enzymes is on the horizon it is unlikely to take place in the near future.
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