Piramal – Understanding Process Safety – Milligram to Tonnage Scale
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Speed to market plays an important role in the success of pharmaceutical organizations and a great deal of efforts are expended to meet desired timelines. Traditionally, the probability of a scale up of a medicinal chemistry route as is for a New Chemical Entity (NCE) is low. Most often, a lot of time and resources are directed to develop and optimize a scalable route. In the process, scalability factors and associated risks of the proposed route undergo assessments without compromising its process safety (1).
Typically, alternative routes are evaluated in parallel, where factors such as the commercial availability of raw materials and reduction in the number of synthetic steps with improved yields to contr ...