Enzyme Supply Scenarios

The various issues that arise when sourcing enzymes and biocatalytic processes can be oiganized by examining two major factors. These are (i) whether the enzyme is commercially available and (ii) whether, and how, the customer has the FTO. The combination of these factors leads to five typical scenarios. 

Enzyme Commercially Available Customer has Freedom to Operate 

This is the simplest situation and the one most like sourcing a traditional chemical reagent or catalyst, hi this case, the enzyme is already commercially available, likely from multiple sources, and the enzyme has no IP encumbrances. Typically, especially for larger, well-established vendors, production processes are already in place, and usually being single sourced is not an issue. 

In this situation, the enzyme is likely one that was obtained through cloning and expression of a gene obtained through research or the public domain (literature, public databases, expired or lapsed patents, etc.). The major issue here is that a production process must be developed for the enzyme and this can add to the time required to establish a supply. The plus side to this situation is that, because of the FTO situation, multiple vendors can be developed by the customer, if necessary. It may also be useful to have a strategy for maintaining the FTO for the enzyme in question as it is possible that others may independently discover the same enzyme or a close variant and potentially block the FTO by obtaining a patent. 

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Consider the phenomenon referred to as spontaneous human combustion (SHC), as publicized from time to time (e.g., as was reported in Arthur C. Clarke s Mysterious Universe, shown on the Discovery Channel, for instance, on October 22,1996, and was mentioned in Charles Dickens Bleak House). If this weird phenomenon does indeed occur, it could instead be referred to as spontaneous ignition, followed by combustion. And if it is at least conceivable for aberrations to occur among the enzyme-catalyzed reactions involved in the metabolism of glucose or other carbohydrates to yield CO2 and H2O, then conceivably there may be a case. Ordinarily, body metabolism reaction rates are miniscule as compared to the direct combustion or combustive oxidation of conventional fuels. If enzyme promoters exist, however, there is the possibility that runaway metabolic processes occur, similar to those in the ignition and further combustion of carbonaceous materials. If so, ample air or oxygen supply would also be required for this extremely unlikely scenario. 

Enzyme Not Commercially Available Enzyme is Proprietary to the Vendor This situation, at least on the surface, is similar to the preceding scenario, except that the enzyme is not commercially available. There are many situations in which a customer may find an enzyme that will work well for a process, but the vendor or IP owner may not want to commercialize the enzyme. This may simply be due to a case of insufficient demand to justify custom manufacture of an enzyme, or it can occur when a company changes its business focus or is bought by another company with no desire to manufacture the enzyme. If the lack of commercial availability is not due to technical reasons, then a supply of enzyme could be developed by negotiation with the IP owner and may involve a third party if the IP owner does not have production capability. This scenario will likely result in reliance on a single supplier unless a suitable agreement can be reached with the IP owner. If a production process has not been developed for the enzyme, then this can add to lead time to establish a supply and increase risk that a suitable supply may not be developed. 

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