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UNMC, The Nebraska Medical Center propose new cGMP facility

Patients with cancer, diabetes and liver failure will find hope in a new facility on the University of Nebraska Medical Center campus designed to advance innovative therapies.

The University of Nebraska Board of Regents will vote today on a proposal to renovate an existing building on the UNMC campus for a new, 11,825 square foot current Good Manufacturing Practices (cGMP) Transplant Production Facility.

The cGMP project is critical to maintaining and advancing UNMC and The Nebraska Medical Center’s position as a leader in oncology and transplantation, said UNMC Chancellor Harold M. Maurer, M.D. It also is key to retaining present patient care capabilities and increasing the number of patients served.
Campus leaders say the building, a joint project between UNMC and its hospital partner, The Nebraska Medical Center, is necessary to comply with federal regulations governing the manufacture and clinical use of cells, tissues and their products.

The $12.5 million project would be funded jointly by UNMC and The Nebraska Medical Center, as well as private donations. If approved, the facility would be housed in the existing Academic and Research Services building at 42nd and Emile streets. Construction would begin in September with occupancy expected one year later.

This expanded clinical research facility offers hope to patients with cancer and failed organ functions and advances our commitment to extraordinary care, said Glenn Fosdick, president and CEO of The Nebraska Medical Center.

UNMC and The Nebraska Medical Center have a long history of achievement in developing treatments for cancer and other diseases based on the transplantation of cellular and tissue-based products, including bone marrow and blood cells, as well as solid organs.

"Were developing new cellular therapies to treat diabetes, liver disease, cancer and other diseases. We are also exploring new techniques to improve the viability of organs prior to transplantation, and ways to increase the number of available organs to improve patient outcomes," said Thomas Rosenquist, Ph.D., vice chancellor for research at UNMC. "Without this facility, Nebraskans will be forced to seek up-to-date treatments elsewhere, and our leadership in transplantation and oncology will fade."

Work similar to that proposed for the UNMC facility is ongoing in cGMP facilities at the Mayo Clinic, University of Minnesota, University of Colorado, University of Miami, University of Chicago and University of Washington, among other places, Dr. Rosenquist said.

The cGMP facility would consist of three specialized areas for processing cells and tissues, cellular transduction and preparing solid organs for transplant, Dr. Rosenquist said. In addition to bone marrow processes, the facility would further UNMC’s work in transplanting pancreatic islets (the source of insulin) and liver cells (as opposed to whole livers). It also would further work in therapeutic cell processing and gene therapy, which includes patient specific vaccines, or customized vaccines for cancer patients.

UNMC recently received a two-year, $500,000 grant to conduct a clinical breast cancer study to test the safety and effectiveness of a genetically engineered tumor vaccine in combination with surgery and chemotherapy.

UNMC’s transplantation program ranks among the best in the world, said Don Leuenberger, vice chancellor for business and finance at UNMC. Since the early 1980s, the solid organ and bone marrow transplant programs have brought more than $500 million into Nebraska, he said, with an economic impact on Nebraska of more than $1 billion.

The high-tech facility requires air-handling systems that are capable of providing 200 changes of air per hour, heated or cooled within one degree with humidity controlled, Leuenberger said. In comparison, air in the new state-of-the-art Durham Research Center is changed once every seven minutes, he said.

If approved, the new facility would replace the Cell Processing Lab on the third floor of University Tower, which is extremely crowded and falls short of the new FDA rules, Leuenberger said.

"The new facility will allow us to remain competitive in clinical care delivery, while boosting our medical research capabilities," Dr. Rosenquist said. "In the end, everyone benefits."