Scientists produce their own experimental therapies to hasten use in clinical trials.
Chemist Christopher Lincoln, Ph.D., sees himself as a cell.
He is no amoeba or bacterium, of course. But in his work at City of Hope, he and his team manufacture substances that cause actions and reactions in the body — much like the molecules made by cells. But these substances are far from ordinary molecules: They are potential new drugs aimed at fighting disease.
Lincoln’s team will use the power of chemistry to create these molecules in City of Hope’s Chemical GMP Synthesis Facility that opened in June. GMP stands for good manufacturing practice, standards set out by the U.S. Food and Drug Administration that help ensure that drugs are pure and consistently potent.
Lincoln, who joined City of Hope in 2009 as a staff scientist in the Department of Molecular Medicine, is director of the new facility. The lab will produce drugs for phase I and phase II clinical trials.
The new facility is a counterpoint to City of Hope’s Center for Biomedicine & Genetics, which produces therapeutic molecules by harnessing genetically engineered cells. The cells become like tiny factories, producing proteins, DNA and other biological molecules that can be used against disease.
Some therapeutic molecules cannot be produced in cells or can be made more efficiently without cells. That is where the new facility comes in.
“We produce new drugs chemically, at the lab bench,” Lincoln said. “In essence, we’re the cells.”
The facility was built so that it can produce sufficient quantities of drugs for City of Hope investigators and, eventually, investigators from other institutions, he said.
In addition, the facility will produce investigational drugs using slightly less stringent standards known as good laboratory practice, or GLP. Researchers use compounds manufactured at GLP standards for testing in the laboratory, not in human studies.
“It’s where we begin to establish the processes we’ll use when we eventually produce GMP-level drugs for human use,” Lincoln said.
One of the first molecules Lincoln’s team will produce is dubbed COH-29.
In laboratory studies, COH-29 has shown promise in stopping tumor growth. The molecule was developed at City of Hope by Yun Yen, M.D., Ph.D., the Dr. & Mrs. Allen Y. Chao Chair in Developmental Cancer Therapeutics and chair of the Department of Molecular Pharmacology, along with David Horne, Ph.D., chair of the Department of Molecular Medicine, and Yate-Ching Yuan, Ph.D., director of the Biomedical Informatics Core.
Working in his research lab, Lincoln already has done much of the GLP work for COH-29. “We’ll be wellprepared to move forward with GMP production when the researchers are ready to begin clinical studies,” he said.
“One of the advantages of having this facility on campus is that we can partner with investigators early in the process of developing potential new drugs,” he said. “This lets us move more quickly and efficiently toward human studies. Ultimately that will bring these new therapies to patients who need them.”
Horne sees the new facility as a major advance for City of Hope.
“Establishing the Chemical GMP Synthesis Facility will render City of Hope with unique and significant capabilities not found in other academic institutions,” he said. “City of Hope is leading the way in academic drug discovery.”
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