Development of a Cryogenic Flow Synthesis and Continuous Extraction Process with Enhanced Yield, Process Control, and Greenness

Time: 9:30 am
day: Day One


  • Delivery of 250 kg drug substance for a late stage, fast-moving oncology asset via a cryogenic acrylamide flow synthesis and continuous work-up
  • Flow reaction was re-engineered on an accelerated timeline to improve greenness, mitigate solubility issues, eliminate potential nitrosamine risk, and improve reaction control during manufacturing
  • To selectively remove a key impurity and increase process yield by 10%, a continuous multi-stage counter current extraction was developed, tech transferred, and implemented in manufacturing within a year. High-speed development was achieved through concurrent wet lab and flowsheet modeling efforts