(207e) Optimization of Zytiga Drug Substance Manufacturing

Zytiga ( treatment of Prostate cancer ) is the most successful launch for J&J in the past five years. Demand  was growing very fast and therefore the drug substance manufacturing process was improved  in all aspects after launch.

-        Optimizing the chemical conversion steps by DOE

-        Optimizing the purification and the milling

-        Optimizing the supply of key raw materials

-        Debottlenecking the process  

This resulted in a second and a third generation process.

Significant improvements with respect to capacity, cost price and BCP were realized.