A new state-of-the-art research facility dedicated to helping produce modified cells for treatment of cancer and other diseases recently opened at the Siteman Cancer Center.
The Good Manufacturing Practice (GMP) center is a haven of high-tech environmental control, comparable in some respects to the International Space Station, according to GMP Laboratory Director Gerhard Bauer.
After a celebratory open house in December, scientists transformed the GMP into an ultra-clean area accessible only to workers outfitted in special suits and protective gear.
Tight regulation of the environment makes it possible for scientists in the GMP to engineer and manipulate cells for use in a variety of medical treatments, including new therapies that harness the power of the immune system to attack cancer and genetic modifications that enhance existing vulnerabilities in tumor cells or open up new lines of attack against these cells.
"The GMP is focused on translational research — taking something developed in the lab and bringing it to the patient's bedside," Bauer said. "It's a state-of-the-art, absolutely modern facility, one of the best available in the country."
The extraordinary dedication to environmental control doesn't primarily stem from a need to keep dangerous materials from getting out. Instead, it keeps dangerous contaminants from getting into the modified cells made at the GMP.
Like a tray of surgical tools, the cells are destined for use inside patients, and have to be produced to exact standards of consistency and purity. The GMP takes its name from the FDA's term for these standards.
The GMP includes six manufacturing rooms where scientists can work independently on different projects. Designers built the rooms from durable materials and equipped them with tight security to eliminate any possibility of cross-contamination.
Preparation is already underway at the GMP for the production of cell lines that researchers hope to use soon in clinical trials.
John F. DiPersio, M.D., Ph.D., the Lewis T. and Rosalind B. Apple professor of medicine and deputy director of the Siteman Cancer Center, plans to modify immune system cells known as T cells for use in the treatment of leukemia patients.
DiPersio plans to inject patients with T cells to destroy any recurrent tumors after bone marrow transplants. However, T cells are also involved in graft-versus-host disease, a primary cause of illness and death in these patients.
To prevent this possibility, researchers will modify the cells to self-destruct in the presence of the anti-herpes drug ganciclovir.
Michael W. Rich, M.D., associate professor of medicine, plans to use bone marrow stem cells to treat heart attack patients. Rich wants to inject stem cells from patients into their own hearts, possibly stimulating the re-growth of blood vessels damaged from the heart attack, and to improve heart function and quality of life.
Bauer notes that experiments have already shown that GMP researchers can reliably isolate bone stem cells within the three-hour window of time normally provided by heart surgery.
According to Bauer, researchers working on 30 different projects at the University have already made arrangement to have materials produced at the GMP.
The University also plans to make GMP services available to other universities and private companies.