MCW BMT Program Cell Processing Facility
The Blood and Marrow Transplantation (BMT) programs at Froedtert Hospital and at the Children’s Hospital of Wisconsin are united as a single Medical College of Wisconsin BMT program through a joint Quality Improvement program, a shared apheresis collection facility operated by the BloodCenter of Wisconsin, and are supported by a shared cell processing facility. The cell processing facility is based at Froedtert Hospital and consists of three laboratories, the Cell Processing Laboratory (CPL), the Lymphocyte Propagation Laboratory (LPL) and a BMT Research Laboratory. All three laboratories are environmentally controlled Class 1000 environments with a HEPA-filtered air supply and laboratory suites that are positive pressure to the corridors. Laboratory leadership consists of Carolyn A. Keever-Taylor, PhD as the Processing Facility Director, and David A. Margolis, MD as the Processing Facility Medical Director.
The CPL performs a broad range of processing procedures including: cryopreservation by controlled rate freezing, thawing using a Dextran/Albumin Wash method to improve cell recovery and reduce infusion reactions, plasma and red blood cell depletion, and cellular subset enrichment using immunomagnetic cell selection devices, and cell depletion by both immunomagnetic devices and through antibody/complement mediated lysis. The laboratory processes autologous and allogeneic products obtained from bone marrow, peripheral blood and allogeneic umbilical cord and placental blood products. The CPL and LPL are accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Foundation for the Accreditation of Cellular Therapy (FACT), the College of American Pathologists (CAP), and are certified under the Clinical Laboratories Improvement Act (CLIA). In addition to processing activities, the CPL and LPL technologists are certified and accredited to perform cell counts on product and patient samples, cell viability assessments, cell subset analysis by flow cytometry, endotoxin and mycoplasma testing of cellular therapy products.
All cellular therapy products collected for patients in the MCW BMT program are issued for infusion or are stored for future transplant by the CPL. In 2007 the CPL processed over 170 products for infusion into just over150 patients, approximately 40% of this activity in support of the pediatric program. The laboratory assumed responsibility for the cryopreservation of apheresis products collected by our BMT program apheresis collection facility partner, the BloodCenter of Wisconsin, in May of 2007. From May through December 2007 the CPL cryopreserved 210 products collected from 127 patients for future transplant use. The CPL operates from 7:30 am until 11:00 pm with Saturday coverage on an on-call basis. The laboratory is regularly staffed by three technologists, with periodic weekday cross-coverage and on-call coverage by LPL personnel.
The LPL is staffed by two technologists who process immunotherapy products for clinical use and are actively involved in preclinical translational development. Active protocols include the generation of Epstein Barr Virus specific CTL for the treatment of EBV-associated lymphomas, including post transplant lymphoproliferative disease and EBV associated Hodgkins Disease. Projects undergoing translational development in the LPL include the purification and expansion of regulatory T cells, the development of suicide gene transduced T cells that can be used for donor lymphocyte infusions, and the development of a transduced cell line to be used for vaccination against neuroblastoma. One of the LPL staff members also serves as the Quality Management Officer for both the CPL and LPL to ensure that the laboratories are in compliance with the many standards and federal regulations for quality control and management. The day-to-day activities of both the CPL and LPL are overseen by a single highly experienced Laboratory Supervisor, Steve Konings, MS, who also serves as the main interface between the laboratory and the support personnel for the MCW BMT clinical and collection programs.
In addition to the two clinical laboratories, Dr. Keever-Taylor also directs the BMT Program Research Laboratory, which is staffed by a Research Scientist and a Research Technologist. The BMT Research Laboratory primarily performs preclinical research prior to translation into the LPL. Currently this laboratory is determining the feasibility of generating cell lines recognizing common viral infections that occur in immunocompromised patients, including Adenovirus, Cytomegalovirus, and Epstein Barr Virus.