City of Hope
Founded in 1913 as a tuberculosis sanatorium, City of Hope today enjoys a reputation as a leading research, treatment, and education center for those with cancer, diabetes, and other life-threatening diseases.
The Duarte, California, center, which is designated as a comprehensive cancer center by the National Cancer Institute (NCI) and is a founding member of the National Comprehensive Cancer Network, is well known for research and treatment protocols that advance care throughout the nation, as well as the compassion that drives those innovations. Indeed, it was recombinant DNA techniques patented at City of Hope that led to the development of synthetic human insulin, and it was City of Hope scientists who developed monoclonal antibody technology, a breakthrough that led to one of the dominant patents in the field for “smart” cancer drugs.
As an independent medical and research institution, City of Hope embraces a culture that breaks through the barriers that have traditionally stood between scientists and physicians, accelerating the application of laboratory findings to more effective treatments. Central to this commitment are City of Hope’s on-campus good manufacturing practices (GMP) facilities.
Despite great promise, many new drugs enter the early stages of drug research (before large-scale human trials) never to be seen again–forever lost in the so-called “valley of death.” This phenomenon often has less to do with lack of efficacy than with a lack of resources and infrastructure needed to successfully transition new agents from the lab to phase I and II clinical trials. At City of Hope, however, a unique approach to drug development is enabling researchers to successfully usher novel therapies through the dreaded “valley of death,” into clinical trials and, ultimately, to the bedside.
City of Hope’s three on-site GMPs are critical to the success of this approach to translational medicine. The largest of these facilities, the Center for Biomedicine and Genetics (CBG), produces biologics, including viral and nonviral gene therapeutics, for on-campus testing while also providing services to outside institutions. The Cellular Medicines GMP facility provides on-site development of City of Hope’s stem cell—based therapy efforts, and the Chemical GMP Synthesis facility–the newest of the three–focuses on small molecules.
This enviable infrastructure arms scientists with everything they need to develop, test, and transition novel agents into clinical trials, and even includes an on-campus regulatory office to facilitate and expedite FDA review.
Even as an increasing number of academic centers jump on the manufacturing bandwagon, with some able to produce materials to meet their own needs, City of Hope remains unique in several ways, not the least of which are manufacturing capabilities that meet chemical, biologic, and viral needs. Also highly unusual is the center’s role as a national supplier, as evidenced by the CBG’s National Institutes of Health (NIH) grant to serve as primary supplier of biologic agents for NIH research at other institutions. City of Hope also shares its expertise with outside companies and institutions, helping to guide them through the regulatory process and sharing expertise about how best to manufacture products for the marketplace.
City of Hope scientists’ work with the imaging agent 64Cu-DOTA-trastuzumab and the breast cancer target known as cancer proliferating cell nuclear antigen (caPCNA) are just two of myriad examples of this unique approach to drug development.
Joanne Mortimer, MD
64Cu-DOTA-Trastuzumab: New Insights Into HER2-Positive Disease
One of the products developed by City of Hope scientists and synthesized in the new Chemical GMP Synthesis facility is 64Cu-DOTA-trastuzumab, a radiolabeled positron emission tomography (PET) imaging agent. Head of City of Hope’s Women’s Cancers Program and Phase I Clinical Trials Program Joanne Mortimer, MD, expects the agent to provide new insights into the biology of HER2-positive breast cancer while helping to identify women most likely to benefit from treatment with trastuzumab.