Developing drugs and preparing them for commercial markets is a challenging task. But as pharmaceutical companies manage manufacturing footprints and capital budgets, securing experienced manufacturing partners has become a priority. Drug development is evolving to treat chronic conditions and potent APIs are playing a central role. Many of these new treatments, including a long list of drugs in development, have very sophisticated chemistries. Not only are these compounds tough to formulate in the lab, their chemistries become more challenging to synthesize and scale in commercial volumes. Early formulation of API chemistry is key for efficient scale-up. Offering insights gleaned from successfully scaling hundreds of API programs, Pfizer CentreOne’s Justin Divan discusses API scaling challenges and advises on best practices and offers his insight.

Read the article here.