(111c) The Development of the Design Space for Maraviroc API

Authors: 
O'Connor, G., Pfizer Pharmaceuticals
Ryan, K., Pfizer Pharmaceuticals


The presentation will describe how QbD principles were practically implemented during the transfer of the maraviroc API manufacturing process into commercial facilities. The presentation will demonstrate how the principles of QbD such as a risk based approach, design of experiments, design space development and six sigma tools were utilised to deliver an efficient, stable and approved manufacturing process exemplified by one of the most challenging steps in the process.