"This facility allows us to isolate, select and potentially expand selected cell populations and manufacture vaccines and other cellular products for our own patients or patients elsewhere. Such products can potentially improve patient outcomes, decrease complications and treat diseases that were previously resistant."
Phyllis I. Warkentin, MD
Biologics is an area of research that is growing rapidly but is limited to select institutions because of the expertise, comprehensive quality management, process controls and the stringent environmental controls required for such work to take place.
The Biologics Production Facility is proud to hold the following accreditations:
Foundation for the Accreditation of Cellular Therapy
Nebraska Medicine’s bone marrow and stem cell transplant program is the only program accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) in the state of Nebraska.
The Foundation for Cellular Therapy (FACT), establishes standards for high quality medical and laboratory practice in cellular therapies. FACT-accredited facilities have met rigorous standards as defined by the leading experts in the field, and based on the latest knowledge of the field of cellular therapy product transplantation and in compliance with governmental regulations. In addition, FACT-accredited Cellular Therapy Product (CTP) facilities have demonstrated compliance with the current FACT-JACI International Standards for Cellular Therapy Product Collection, Processing and Administration.
FACT has been located at the University of Nebraska Medical Center (UNMC) since 1996, shortly after the organization became incorporated. Our faculty has also provided our expertise and support to the organization in a number of areas. Phyllis I. Warkentin, MD, professor of Pathology and Pediatrics at UNMC, is medical director for FACT and a member of the board of directors. A number of faculty members serve as FACT inspectors and provide training for inspectors.
Accredited services for Nebraska Medicine include:
- Adult and pediatric transplantation, which is defined as a clinical facility that is responsible for all aspects of patient care and treatment, including the infusion of cells with the intent of providing transient or permanent engraftment in support of therapy of disease.
- Autologous transplant, which involves cells taken from one individual and transplanted back into the same individual.
- Allogeneic transplant, which involves cells taken from one individual and transplanted into another genetically diverse individual.
- Collection, which involves the collection of cellular therapy products from a donor and is labeled. Nebraska Medicine is involved in both bone marrow collection and peripheral blood progenitor cells.
- Processing laboratory, which is a location where cellular therapy product processing activities are performed. The facility is responsible for all aspects of manipulation, cryopreservation, packaging and labeling of cellular therapy products, regardless of source.
Nebraska Medicine has been accredited by the AABB since the early 1990s. The AABB accreditation program evaluates an institution’s quality and operational systems for conformance with AABB standards, the Code of Federal Regulations and federal guidance documents. This program helps institutions maintain the highest standard and quality of care.
AABB is an international association representing individuals and institutions involved in activities related to transfusion and cellular therapies, including transplantation medicine. AABB member facilities are responsible for collecting virtually all of the nation’s blood supply and transfusing more than 80 percent of all blood and blood components used in the United States.
The College of American Pathologists
Nebraska Medicine’s Pathology/Clinical Lab has been accredited by the College of American Pathologists (CAP) since the beginning of cell therapy in Nebraska which took place in the early 1980s at Nebraska Medicine. With this accreditation, Nebraska Medicine joins an exclusive group of more than 6,000 laboratories worldwide that have met the highest standards of excellence.
The CAP Laboratory Accreditation Program is an internationally recognized program and is considered the gold standard for clinical labs. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care.