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.
Using the Facilities
Resources for Grants
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The cGMP production laboratories at the Chemical GMP Synthesis facility focus on providing researchers with services for drug discovery, process research, development, and early clinical manufacturing of pharmaceutical drug substances.
The facility's design 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 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 from 0.5-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 and GMP release and characterization of APIs
Using the Facilities
Basic Text Field
The CGSF provides services for several areas: drug discovery, process research, process development, and manufacturing of APIs.
GLP and GMP Synthetic Capabilities
Fully equipped development labs
Manufacture of API and fine chemical raw materials and intermediates
Synthesis of various compound classes
Reference compound synthesis
Purification to FDA standards
Aseptic Fill & Finish capabilities for parenteral preclinical and phase I and II products
API Manufacturing Services
cGMP manufacturing for preclinical and clinical APIs (phase I and II)
Gram to multikilogram synthesis
Batch record generation
Technical support and technology transfer
CMC and DMF
Process development and scale-up
Asymmetric synthesis, transition metal-catalyzed reactions, low-temperature reactions and heterocyclic chemistry
David Horne, Ph.D., is one of the institutional leaders in all aspects of academic scientific and medical education, shaping the scientific and educational vision for City of Hope. He serves as vice provost and deputy director of Beckman Research Institute of City of Hope and dean of faculty affairs, overseeing the International Research Programs and the Office of Faculty Affairs. Dr. Horne’s professional experience is complemented by impressive academic achievements in medicinal chemistry and drug development.
The OligoPilot 400 is a synthesizer specifically developed to synthesize quantities for early clinical trials. This mid-range oligonucleotide synthesizer covers a range from 4mmol to 60mmol for the therapeutic oligonucleotide market.