An NCI-designated Comprehensive Cancer Center
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. 

Meet the Team

Core Director, Chemical GMP
Core Manager, Chemical GMP

Abstract for Grants

The cGMP production laboratories at  the Chemical GMP Synthesis Facility are focused on providing researchers with services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances.
 
The design of the facility allows for three simultaneous processes to be performed, under cGMP in functionally isolated areas of the facility.
 
Our chemists specialize in the synthesis of complex small molecules and possess experience in both industrial and academic environments, with a broad range of synthetic capabilities and the knowledge of  the latest technologies and techniques.
 
Our secured, state-of-the-art facility features:
 
  • Class 10,000 facilities for delivering intermediates and API for clinical applications
    • Gram to kilogram production runs
    • Glass jacketed reactors from0.5 liter to 100 liter capacities
    • Automated chromatographic equipment for purification
    • Key-card-restricted access
    • Provisions for N2 or other gases
    • Validated monitoring of all equipment, including HVAC
    • Quality control, quality assurance and product release, storage and management
 
  • Integrated quality control
    • Dedicated analytical laboratory
    • Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs