Manufacturing Overview

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