"I foresee that there will be many more diseases in the future that we will be able to be treat with products or vaccines that can be produced here. We are only limited by our creativity and our imagination."
Phyllis I. Warkentin, MD
The 20,000 square foot Biologics Production Facility provides a critical venue for researchers to transition small scale basic science research findings to useful therapeutics at the bedside through phase I and II clinical trials. Our technologists and scientists are experienced at scaling up projects to get them ready for human trials using stringent closed production methods whenever possible.
The Biologics Production Facility currently focuses on four promising areas of therapeutic medicine: stem cell collection and processing, cellular-based vaccines and therapies, tissue-based therapies and regenerative medicine therapies in addition to the new and emerging field of nanomedicine.
Stem Cell Products
As one of the early pioneers in the field of bone marrow and stem cell transplantation, Nebraska Medicine has been involved in the manufacture, processing, cryopreservation and storage of bone marrow and stem cells for more than 30 years. The program draws patients from across the country and around the world and is ranked as one of the busiest adult lymphoma and pediatric programs in the country, averaging 150 transplants a year.
In our class 10,000 clean air suite, products are prepared according Good Manufacturing Practice and Tissue Practice (GMP/GTP) regulations and clearly defined and controlled manufacturing and cryopreservation practices. We process nearly 300 to 400 bone marrow and peripheral blood stem cells and stem cell-based products for Nebraska Medicine as well as other clinical facilities across the country each year.
Cellular-Based Vaccines & Gene Therapies
The Biologics Production Facility houses four class 10,000 rooms that can be used for cellular-based vaccines and gene therapies. Nebraska Medicine has been an early pioneer in the study and development of cellular vaccines and gene therapy that are patient-specific or customized for certain diseases. These treatments hold significant therapeutic promise for the treatment of a number of diseases including cancers and genetic, metabolic and auto-immune diseases. Cellular-based vaccines involve the transfer and manipulation of autologous or allogeneic cells for therapeutic purposes. This facility provides scientists the capability to produce individualized vaccines made from a patient’s own cells by manipulating the cells in vitro, and then using viral vectors to program the cells to attack tumor cells. Our scientists are also making new inroads into gene therapy, which involves altering the genetic material of somatic cells and infusing these into patients to correct the underlying disorder.
The Biologics Production Facility includes two class 10,000 clean air suites with adjacent class 100 areas for organ and tissue manipulation and processing. Scientists in this area specialize in the manipulation of tissues or organ-derived cells that are intended for implantation, transplantation, infusion or transfer into a patient for disease treatment. The new facility opens new opportunities to further advance Nebraska Medicine’s world-class organ transplant program work and our pioneering work in the use of pancreatic islets and liver cells. One of the most promising areas is in the development of new ways to make use of organs that are not suited for transplant by making a suspension of the cells that are important in a particular organ or for growing a new organ. Our physicians are leaders in autologous islet transplants, liver and pancreatic resections. Autologous islet transplant involves removing the pancreas, harvesting the islets from the pancreas and transplanting them back into the liver, which allows the islets to produce insulin in their new location.
Regenerative Medicine Therapies
Regenerative medicine involves innovative medical therapies that enable the body to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs. It encompasses a variety of research areas including cell therapy, tissue engineering, biomaterials engineering, growth factors and transplantation science.
Scientists worldwide are exploring a variety of research activities such as the repair of damaged heart muscle after a heart attack, replacement of skin for burn victims, restoration of movement after spinal cord injury and regeneration of pancreatic tissue to produce insulin for people with diabetes. As one of the top solid organ transplant programs in the country, Nebraska Medicine has been involved in research focusing on regeneration of the pancreas, intestinal, and liver cells.
Nebraska Medicine is a leader in the field of nanomedicine, a rapidly growing field in which small particles are used to improve drug delivery systems. The Biologics Production Facility provides an ideal environment for manufacturing therapeutic products for pre-clinical evaluation and clinical trials.