A QbD Approach to the Process Development of Tofacitinib

Tofacitinib citrate (CP-690,550-10) is currently being evaluated for the treatment of rheumatoid arthritis, psoriasis and other diseases. An NDA has recently been submitted to the FDA for the treatment of rheumatoid arthritis. The Pfizer Tofacitinib API Team has worked to improve the efficiency of the process and ensure that the quality of the drug substance will meet the standards of the regulatory agencies. Quality by Design is important not only from a regulatory perspective, but also from a process development perspective since it enforces a much more thorough degree of process understanding. DOE is often the focus of QbD but there are often other techniques (experimental and modeling) that can be used in the development of a process. This talk will provide examples of how we use these various techniques to ensure we have a robust process that can be run at a wide range of scales and consistently meet our quality standards.