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This influence is reasonably apparent with respect to issues of thermochemical safety and probable environmental impact; yet, there is across-the-board synergy that a chemistry=engineering dialogue can exploit. The latter is particularly true in those instances when the chemists perceive a desirable approach as not being feasible on grounds of scale-up difficulty or, more simply, because of lack of experience with some demanding processing conditions. c. The consolidation stage, in which the synthesis route is fully settled and the specific process for it is defined at the level of detail that permits process design for the manufacturing plant, definition of the bulk drug attributes and the assembly of the dossier.

3. What are the scale-up issues? Can they be addressed on time? 4. What is the environmental impact? Is there a good fit with the likely plant sites? Once the bulk process team gets past this juncture with an action plan, the rest of the development stage is mostly a matter of good execution by all the disciplines involved. Although the Analytical R&D function has not been mentioned up to now, its role is, of course, pervasive throughout; first in support of the early preparative work (a duty that remains with the function for the rest of the development cycle), then in decisive and indispensable participation of the development activity at the bench and in the pilot plant.

Or perhaps the greenest route seems least feasible. Additionally, the selection may be constrained by compelling demands of the drug development program: for example, the most attractive route would take longer to be ready for preparative work and development; it has to defer to the lesser route that can prepare bulk drug now—not an uncommon juncture and decision, although it can be subsequently reversed. ) (15). , a chiral intermediate that would bring all or a good deal of the target chirality with it), a selling approach that fine chemical producers exploit.

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