The Diabetes Research and Wellness Islet Resource Facility
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So, why do we need a biosecure facility to breed and maintain these source animals? The use of living pig tissue for transplantation into humans is subject to stringent guidelines by regulatory authorities like the Food and Drug Administration. Bacteria and viruses are removed from the pig herd, and the animals need to be housed such that they stay free of such infectious agents (the designated pathogen-free status).
Spring Point Project and the Diabetes Institute have selected a special strain of pigs with high islet cell yield. The design of the building, operations within the building, and the designated pathogen-free status are in compliance with regulatory guidance regarding the clinical application of xenotransplantation products. The design and proposed health status of animals has been documented in a submission to the Food and Drug Administration, and has received a favorable response.
The 21,000-square-foot facility's design was completed in May 2006, and construction started in June 2006. The grand opening was in February 2007, and the facility was named the Diabetes Research and Wellness Islet Resource Facility (IRF) to acknowledge a major gift by DRWF. In full operation, the Islet Resource Facility is capable of housing approximately 100-150 young-adult pigs.
The $6.2-million IRF is a state-of-the-art biosecure research facility. Features include flexible handling, husbandry, and reproduction of pigs under different conditions. Animals can be held in distinct units that are separated from each other regarding air circulation, water supply, and more in order to avoid cross-contamination. Also, it's possible to conduct advanced reproduction methods, such as the birth of newborn piglets by Cesarean section, artificial insemination, and embryo harvest and transfer.
Animal housing and handling is in full compliance with guidelines and regulations allowing certification from the United States Department of Agriculture (USDA) and the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). An Institutional Animal Care and Use Committee oversees protocols and procedures to ensure that these are consistent with regulations regarding proper care and use, and humane treatment of animals.
One week after the official opening, the first piglets were delivered inside the barrier of the building by Cesarean section. These and subsequent deliveries went very well, and all animals delivered fulfilled the designated pathogen-free status. Subsequently, a natural breeding program was initiated at the end of 2007, and the first piglets in the second generation were born at the end of April 2008. This second generation is particularly important because that's when the animals can be used for transplantation.
