Michael Tracey, Ph.D.
Michael Tracey, Ph.D.
Research Fellow
Science and Technology
Cambrex Charles City
Technology Transfer and Process Development of Step 2 for Danicopan
Danicopan is a first-in-class oral Factor D inhibitor used as add-on therapy for patients with paroxysmal nocturnal hemoglobinuria who experience extravascular hemolysis. This presentation follows Step 2 of the commercial synthesis, an N-Boc deprotection, from initial technology transfer through validation and commercial manufacturing at Cambrex Charles City, one of the largest small-molecule API sites in the world. The transferred process used solvents and unit operations that were not well suited for large-scale manufacturing. Applying green chemistry principles, the team completed an acid and solvent screen that replaced problematic solvents and simplified the workup. Spike, fate, and purge studies, Design of Experiments, and Proven Acceptable Range studies fully characterized the process and established Normal Operating Ranges and in-process controls to support validation. The optimized process delivered 1,319 kg of the intermediate across 29 batches with high purity and yield. Attendees will see a practical case study of a common reaction transformed into a greener, faster, and more robust manufacturing process.
Michael Tracey
Michael Tracey grew up in Minnesota and received his BS in chemistry from Denison University (Ohio). He returned to Minnesota to attend the University of Minnesota and under the direction of Professor Richard Hsung where he investigated the synthesis and reactivity of allenamides and ynamides. Michael then moved on to a post-doctoral position at Stanford University with Professor Barry Trost. Staying in California, Michael joined the Process Research and Development group at Theravance in South San Francisco. In 2008, he moved to the Chemical Development group at Cambrex Charles City (Iowa) where he is a Senior Research Fellow who has worked on 30+ projects that were transferred to production scale ranging from 0.5 kg to >1000 kg.
Hosted by Professor Alexander Grenning
