Challenges in Developing and Scaling Up Chemical Processes

The generic industry, by its very nature, is a very competitive arena. Opportunities flash in and out continuosly. Process development teams have to develop APIs that  

By the time that generic companies start working on any given product, several process patents may have been filed, thus restricting the choice of routes. Many of the obvious and commercially feasible routes are usually patent protected, and the processes disclosed in the earliest patents normally disclose connmercially unworkable processes. In addition, solid-state characteristics such as different polymorphs and solvates, particle sizes, and bulk densities of APIs and key intermediales are protected extensively by patents. Therefore, the process development chemist faces a twofold challenge (1) identify a route that is free of any patent issue, and (2) ensure that the product obtained by using such a process is also free of any patent issues related to polymorphism, solvates, and so on. 

As noted above, of late, patenting sohd-state characteristics, impurities, metabolites, and so on, has been used increasingly as a product-life-cycle management strategy. Associated challenges for the process development chemists are development of alternative polymorphs. 

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