The Chemical GMP Synthesis Facility (CGSF) is designed for the manufacture of active pharmaceutical ingredients (API) for phase I and phase II clinical trials. The ISO 7 manufacturing facility is organized into four isolated, independent suites housing dedicated equipment for small molecule and RNA/DNA therapeutic manufacturing. Bulk API packaging, aseptic formulation/vialing and stability options are available for both RNA/DNA and small molecule therapeutics.
Recent efforts to expand capacity for RNA/DNA manufacturing have been achieved with the acquisition of the GE OligoPilot 400 synthesizer and GE AKTA Process purification system. This expansion allows for developmental manufacturing, as well as achieving quantities suitable for clinical supply.
Small molecule manufacturing is carried out in dedicated Chemglass jacketed glass reactors, with capacities from 500mL to 100 liters. Synthesized compounds are purified via flash chromatography using the automated Teledyne Isco Torrent purification system, allowing for quick and efficient isolation of intermediates and final products.