API Manufacturing

Cryogenic API Manufacturing

Well beyond refrigeration – cryogenic cold

API Manufacturing and cGMP Polymer Manufacturing

PCI Synthesis, part of SEQENS CDMO is equipped to run low temperature chemical reaction at research, development, pilot, and commercial scale (4,000 Liter). All of our equipment is ready to carry out reactions to as low as -80°C. Running certain processes under extremely cold temperatures—much colder than standard freezing—can be useful in for certain molecular transformations.

Cryogenic conditions can:

  • Limit impurities
  • Process highly reactive compounds such as organolithium reagents
  • Improve reaction selectivity
  • Eliminate or reduce unwanted side reactions
  • Limit volatility of compounds for greater safety until conversion is completed
  • Prevent ice crystals from forming

Once the desired molecule is formed using one of our jacketed cryogenic reactors, such cold conditions may no longer be required and development and/or manufacturing proceeds under normal conditions for that particular drug substance.

This expertise, along with the proper equipment, enables us to easily perform and scale-up the following reactions that are most often done under low temperature conditions:

  • Halogen-metal exchange (e.g. Li)
  • Li, Na metal reductions
  • Selective deprotonation and subsequent stereoselective, regioselective and chemoselective reactions
  • Stereoselective, regioselective and chemoselective reductions of ketones, Imines and Esters
  • Asymmetric reactions such as Michael additions
  • Selective Freidel-Crafts Acylation (e.g. with Oxalyl Chloride)
  • Low temperature Swern Oxidations