Research at The Nebraska Medical Center Biologics Production Facility
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Uploaded on Dec 28, 2011
The Biologics Production Facility provides investigators with the isolation, environmental control and security required for the manufacture of drugs, vaccines, human cells, tissues, cellular or tissue-based products to test and develop new medical therapies.
With a reputation for cutting-edge research and treatment, The Nebraska Medical Center is home to the region's largest Biologics Production Facility. The 20,000 square foot facility is designed to support scientific and clinical investigators in developing and testing the most promising new medical therapies through the manufacturing, production and modification of cells, tissues, cellular and tissue-derived products. The facility provides an important venue for researchers to transition small scale basic science research to the bedside through phase I and II clinical trials. The Nebraska Medical Center has had a long history of achievement in developing treatments for cancer and other diseases through the transplantation of cellular and tissue-based products, including bone marrow and stem cells, as well as solid organs. The Biologics Production Facility allows The Nebraska Medical Center to increase its capabilities in these areas as well as other areas of therapeutic medicine with the goal of improving cancer treatments and other difficult to treat diseases using the most modern medicine techniques.
About the facility
The Biologics Production Facility meets Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP), which provides investigators with the isolation, environmental control and security required for the manufacture of drugs, vaccines, human cells, tissues, cellular or tissue-based products for medical therapy purposes.
The facility includes six individual clean room suites that achieve Class 10,000 to 100 air quality as well as another completely segregated area that can support other clinical projects such as xeno transplantation. These suites share a quality control laboratory for release testing of products and other assays; a media preparation room for bulk reagent production; cleaning, disinfecting and sterilization equipment.
A comprehensive quality system is in place that applies to all projects within the facility, including controlled access, personnel and training; documentation, production and process controls; environmental monitoring; and management of occurrences, deviations, adverse events and correction action.
For more information, visit http://www.nebraskamed.com or call 1-800-922-0000.
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