Cell Processing Facility
The Institute for Cellular Therapeutics operates as one of the most sophisticated cell processing centers in the country. Under the auspices of Dr. Suzanne Ildstad, Director, Dr. David Tollerud, Associate Director and Mary Jane Elliott, Cell Processing Facility Manager, an extensive processing facility has been developed for processing bone marrow stem cells from iliac crest, vertebral bodies and mobilized peripheral blood.
The general facility is FACT (Foundation for the accreditation of Cell Therapy) accredited and CLIA (Clinical Laboratory Improvement Amendments) certified. The area designated for clinical processing encompasses 2,000 square feet and can accommodate two simultaneous cell processing procedures for two separate subjects. Approximately 1,200 feet of the facility is a controlled clean room environment. The facility clean-room meets at a minimum, class 10,000 (ISO 7) FDA standards, with positive pressure, laminar flow and temperature regulation, and is equipped for cell separation, purification and cryopreservation.
This facility is run according to current Good Manufacturing Practice (cGMP) guidelines and is staffed with dedicated personnel who undergo continuous training and proficiency testing. A Quality Assurance program is in place to monitor and verify compliance with regulations and to ensure consistent product quality.