UNMC_Acronym_Vert_sm_4c
University of Nebraska Medical Center

Capabilities

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.



Main Areas

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.
Tissue-Based Therapies
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.
Nanomedicine
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.

Experience

Nebraska Medicine has played a primary role in the development of innovative treatments for cancer and other diseases through the transplantation of cellular and tissue-based products since this field's early infancy. Our hospital labs have served as the primary processing and storage facilities to support these cutting-edge treatment therapies, which require strict standards and tightly controlled environments to prevent product contamination.

Bone Marrow and Stem Cell Transplant Program

Dr. Julie Vose

Since the program's founding more than 25 years ago, physicians and researchers at Nebraska Medicine program have been pioneers in the field of bone marrow and stem cell transplantation and the processing of these products. Nebraska Medicine is recognized internationally for a number of ground-breaking advancements that have helped improve success rates and have made bone marrow and stem cell transplants a more viable and promising option for a growing number of patients. This includes those with lymphomas, leukemias, multiple myeloma as well as some blood disorders.

The first of these revolutionary achievements was the study and introduction of autogolous transplantation by James Armitage, MD, hematologist/oncologist, and his colleagues at Nebraska Medicine. Another milestone was the development of stem cell transplantation, which was introduced in 1984 by Margaret Kessinger, MD, hematologist/oncologist. The use of peripheral blood-derived stem cells as opposed to bone marrow-derived stem cells has become the standard of care for transplantation and has helped improve outcomes for autogolous transplant patients.

Julie Vose, MD, hematologist/oncologist and chief of Hematology/Oncology at UNMC's Department of Internal Medicine, is one of the country's leading experts on lymphoma. She has been conducting research on the disease for 18 years and is the principal investigator for numerous clinical research trials.

Solid Organ Transplant Program

Cooler with organ being delivered
The Transplant Center is home to one of the largest and most successful programs in the world for kidney, liver, pancreas, intestinal and multi-organ transplants. Founded in 1970, the kidney transplant program performed the first kidney transplant in the state and has become widely recognized as one of the most active and innovative kidney and pancreas transplantation centers worldwide.

The liver transplant program, now more than 25 years running, has earned an international reputation and worldwide referral base. In 2004, the program reached a milestone shared by very few transplant centers in the country by performing more than 2,000 liver transplant and more than 500 pediatrics liver transplants, making it one of the most active and advanced centers in the world.

Innovation, solid outcomes and high patient survival rates have bolstered the status of the intestinal transplant program as a national leader. Our transplant specialists were among the first to begin performing combined liver and small bowel transplants. In 1993, the medical center became one of the first transplant programs to perform isolated intestinal transplants. Today, the Transplant Center is one of a few facilities in the country with expertise in this unique transplantation technique -- and one of the busiest.

Continuing a pattern of success and innovation, the Transplant Center broke ground in 1989 by starting a pancreas transplant program at a time when this procedure was just beginning to gain acceptance. Since then, the pancreas transplant program has experienced overwhelming success and is among the most active and pioneering centers in the world. The Transplant Center became the fifth center in the world to perform more than 200 pancreas-only transplants and consistently ranks within the top five centers for performing adult pancreas transplants. Nebraska Medicine is a leader in islet transplantation, liver and pancreas resections, and adult-to-adult living donor transplants.

Cellular-Based Therapies

Dr. James Talmadge

Nebraska Medicine has been involved in gene therapy and the development of cellular vaccines since this field’s early beginnings. James Talmadge, PhD, a research specialist at UNMC, has been active in molecular, cellular and gene therapies for the treatment of breast cancer for many years. Gene therapy and cellular vaccines show much promise in providing additional treatment options for cancer and metabolic diseases.