A Right First Time Approach to Early Process Development

In order to shorten the development time, it is important that resources in development be focused on doing things “Right the First Time”. The cost of making a chemical compound that potentially has very attractive properties might be prohibitively high and finding a feasible alternative route quickly is imperative. History shows that even very promising drugs don’t make to market because of their relative high costs of manufacturing. However, this may have been avoided if the researchers, early in Discovery or Development, could have identified the need for an alternative less expensive route. In this paper, we describe a process evaluation methodology to be used either in Discovery or in Development during route selection or early process development. It is very important from business perspective to properly evaluate the process as early as possible and understand the impact of various factors and variables on the final cost of goods of the chemical. Selecting the best route early and employing valuable resources on the right steps of the chemical synthesis early can save company a significant amount of time and money.