A new center for the development of cancer vaccines, gene therapies and other biological treatments opens today at the Johns Hopkins Oncology Center.
Scientists plan to begin work next month on a breast cancer vaccine designed to stimulate the immune system to fight the disease. Other plans call for the preparation of vaccines against cervical cancer and lymphomas.
Equipped with filtration systems and scrubbers that make it the most sterile environment on the East Baltimore campus, the center will be used to manufacture and test biological products before they are marketed to pharmaceutical firms.
"It will enable us to get therapies developed here at Hopkins to patients at a faster rate," said Dr. Elizabeth Jaffee, associate director of the new Cell and Gene Therapy Laboratory. "It's going to speed up the process by several years."
In theory, Hopkins will hold patents on products developed at the center and then license them to drug companies for wider-scale testing and manufacture. The university would derive royalties from the sale of the products.
Though most of the projects will involve the manipulation of genes to fight disease, others fall outside the genomics field but require the highly sterile conditions and quality control available there.
These, according to Jaffee, will include the harvesting of insulin-producing cells from donated pancreases. These cells, when transplanted into patients, have been shown to be an effective treatment for diabetes.
The center, located in the new cancer research building off North Broadway, is a joint project of the Johns Hopkins Oncology Center and the School of Medicine. It will be available to faculty members across all disciplines.
Among the six full-time employees are two specialists in quality control and government regulation who are charged with making sure the facility complies with the array of requirements aimed at patient safety.
Jaffee acknowledged that centers engaged in gene therapy research have come under intense scrutiny in the wake of a young man's death in a clinical trial at the University of Pennsylvania last year.
With its $2.1 million price tag, the center will cost $500,000 a year to run. Much of this is the cost of keeping the rooms sterile. Twice a year, for instance, the facility will have to shut down for replacement of filters, light bulbs and other equipment.
This must be done, Jaffee said, so nothing breaks down or requires changing during a project - a disruption that could compromise the sterility of a product under development.
The Hopkins facility is one of only 12 university-based centers in the United States devoted to the development of gene therapies.
Scientists will begin work on a product once they have developed working models in their own laboratories and, in many cases, tested them on animals. To be tried on humans, products must be made under more stringent requirements.
Dr. Curt Civin, director of pediatric oncology, said drug companies are equipped to do this but often aren't interested in investing large sums of money until the products have proved themselves in early experiments.
"You want to have a small facility to do small-scale trials that might prove a principle - and reduce the risk so that a drug company might take it on," Civin said.