Viiiin Closing

Clearly, this chapter has described bulk drug process development as a complex, richly textured activity that is deeply rooted in scientific and engineering skill. The discussion has been largely based in the context of a large drug company where all the requisite skills reside, mostly in R&D, but complemented well by those of the downstream organizations.

The reader may well ask, particularly as the new drug business faces increased pressures to do it faster and in a more regulated environment, does the smaller organization have a chance to succeed? What if the seemingly indispensable critical mass is not there and, instead, the task must be done by dovetailing as best one can resources and functions from multiple organizations? To the author the answer is clear. Bulk drug process development is a business where size matters and matters greatly, and if success is measured by the timely introduction of new drugs (not just one drug at a time) on a broad marketing base, then the smaller organizations labor at a disadvantage and the virtual company struggles with projects of any scope. Indeed, for bulk drug projects of unusual technical difficulty, the smaller organization seems faced with insuperable odds. Yet, none of this denies the opportunity for the bulk drug process developer practitioner to excel and find professional fulfillment in any environment without regard to size; all that is needed is the requisite skill and dedication to one's work, as well as reaching out for the best possible collaborations that might be available.

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