The Chemical GMP Synthesis Facility (CGSF) is a state-of-the-art manufacturing facility for small and large molecule therapeutics for clinical trials. The CGSF provides services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances (APIs) that meet Food and Drug Administration requirements. With its significant capabilities, the CGSF plays a key role in bridging basic science and translational medicine at City of Hope. It is a key component within the Developmental Cancer Therapeutics Program. The facility is designed specifically to produce quantities of API on scales suitable for use in preclinical toxicology studies and phase I/II clinical trials.
The CGSF provides internal and external investigators with a regulatory compliant, cost effective route to bringing promising therapeutics to the clinic.
The manufacturing suites are designed specifically to accommodate gram to kilogram production of cGMP-grade small molecule, biopolymer (peptides, siRNA-aptamers, DNA-peptide hybrids) and nanomaterial APIs in support of phase I and II clinical trials. Adherence to cGMP (current good manufacturing practices) is essential in ensuring the quality and integrity of manufactured APIs.
Our on-site quality control unit is committed to providing excellence in service for the testing and release of manufactured APIs with strict adherence to requirements set forth by the Food and Drug Administration.
The CGSF is under the direction of Christopher Lincoln, Ph.D.
who leads a team of synthetic and analytical chemists in providing an array of services and support in bringing benchtop discoveries to the clinic. These include:
- Route selection and optimization
- Process development and scale-up
- Synthesis of GLP API for toxicology
- Synthesis and characterization of metabolites, impurities and reference standards