ABSTRACT

Once a potentially useful drug is discovered, it is patented as soon as possible. This is essential because competitors may be working in the same field of research, and may be studying the same kinds of compounds. Once a novel compound has been identified as being potentially useful, it is necessary to develop a large-scale synthesis for it. This is the job of the chemical development laboratories. The priorities in chemical development are to devise a synthetic route that will be cheap, efficient and high yielding, have the minimum number of synthetic steps, and consistently provide a high quality product that meets predetermined specifications of purity. Process development is part of the chemical development program and aims, not only to develop the individual steps in the synthetic route, but to ensure that they are integrated with each other so that the full synthesis can be run smoothly and efficiently on a production scale.