Avoid the do-over: Why early investment in a scalable manufacturing process is critical


The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.

How can developers avoid these costly delays? Investing in a scalable manufacturing process early-on can make the difference between advancing through drug development in a productive, step-wise fashion and having to redo early-phase work to correct problems.

Author: Enrico Corona, Director of Pharmaceutics & Process Technology and Jonathan Sutch, Senior Manager, Formulation Development