(466c) 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.