In: Chemistry
Discuss whether chemical development is simply a scale-up exercise.
chemical development is simply a scale-up exercise !
chemical development : this term is used when, a compound goes forward for preclinical tests, it becomes necessary to start the development of a large-scale synthesis at the earliest. It is carried out in specialist laboratories. During the drug discovery and design , emphasis is on producing as many different compounds as possible in as short a period of time as possible.The yield is unimportant as long as sufficient material is obtained for testing. The reactions are also done on a small scale, so the cost is trivial, even if expensive reagents or starting materials are used. Hazardous reagents, solvents, or starting materials can also be used as small quantities are involved. (Green chemistry)
Quantity of the drug may be obtained by scaling up the synthetic route used by the research lab,but in longer duration it may prove unsustainable.
For chemical development a synthetic route has to be devised
which is straightforward, safe, cost-effective, efficient, high
yielding, has minimum number of synthetic steps, and it shall
provide a consistently high-quality product which meets
predetermined specifications of purity.
(QAQC)
This all is taken into consideration during chemical development ,
due consideration is also given to the priorities required for
scale-up. Once the reaction conditions are optimized, the process
needs to be scaled up. The priorities here are cost,
safety, purity, and yield. The specifications of the final
product are defined and determine the various analytical tests and
purity standards required.
Thus, chemical development is much more than simply scale-up exercise.