November 22, 2011 | by City of Hope Staff
A new, high-tech facility at City of Hope soon will cut out the middleman when it comes to drug manufacturing — and help get City of Hope-designed drugs into clinical trials more quickly.
It’s called the Chemical GMP Synthesis Facility, and it’s scheduled to open in 2012. GMP stands for good manufacturing practice, standards set by the U.S. Food and Drug Administration (FDA) to ensure that drugs are pure and consistently potent. Most importantly for patients, the facility will mean that more drugs with cancer-fighting potential will be created and tested for safety without getting held up by as many processing delays.
According to the FDA, it typically takes more than eight years of study and testing before the agency will approve a drug for general use. One of the chief hurdles for bringing a new drug into use is testing it in clinical trials. To do this initial testing, scientists need to produce large quantities of the drug under strict quality guidelines.
Academic scientists have plenty of promising ideas, but they don’t have the resources to produce drugs to these high standards. They have to partner with pharmaceutical companies or specialized manufacturers, often adding precious time to the process. Just negotiating the terms of a partnership can take months or years.
The new Chemical GMP Synthesis Facility will produce synthetic drugs for phase I and phase II clinical trials. It serves as a counterpoint to City of Hope’s existing manufacturing facility, the Center for Biomedicine & Genetics, or CBG. That facility uses cells to produce proteins, DNA and other biological molecules that can be used against disease. But some molecules can be made more efficiently in the lab, and that’s where the new GMP facility comes in.
In the beginning, it will manufacture drugs created by City of Hope scientists. Eventually, scientists from other institutions will be able to use it, too.
One of the first drugs to be produced will be COH-29 — an investigational medication that might replace hydroxyurea, a drug used for more than six decades to treat leukemia, melanoma and other cancers. If clinical trial evidence bears out its potential, the drug — like others to follow — will more quickly and easily reach a commercial pharmaceutical maker and the general public.