A QbD Approach to the Process Development of Tofacitinib

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
AIChE Annual Meeting
October 31, 2012 - 1:15pm-1:30pm

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.


Professional Development Hours
0.5 PDHs
You will be able to download and print a certificate for these PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.

Would you like to access this content?

No problem. You just have to complete the following steps.

You have completed 0 of 2 steps.

  1. Log in

    You must be logged in to view this content. Log in now.

  2. Purchase Technical Presentation

    You must purchase this technical presentation using one of the options below.
    If you already purchased this content recently, please click here to refresh the system's record of ownerships.


Credits 0.5 Use credits
List Price $25.00 Buy now
AIChE Members $15.00 Buy now
AIChE Undergraduate Student Members Free Free access
AIChE Graduate Student Members Free Free access