Overcoming Late-Stage API Development Bottlenecks

By Marti Bartra and Montserrat Monsalvatje, Esteve Química

It is difficult to predict, during early development, when later-stage development activities may take place. In later-stage projects, though, tasks are more well-defined — typically, it is easier to determine the necessary resources and to combine different tasks and projects utilizing shared resources. Additionally, early-stage project development often is completed by CROs focused on manufacturing small quantities of active pharmaceutical ingredient (API) very quickly. They may not consider industrial and/or GMP requirements.

But meeting aggressive development timelines often demands completing remaining process and analytical tasks in parallel, as well as compensating for any lack of information. Esteve accomplishes this by setting up core teams when we begin a project, including not only personnel from R&D, process development, analytical development, and project management — as one would expect — but also representatives from production, quality, procurement, and environmental health and safety (EHS). This allows us, through regular meetings, to identify potential issues in production, quality control, EHS, and more. This helps us maximize efficiency during transfer — key to reducing project bottlenecks and delays.