The Elmer and Sylvia Sramek Charitable Foundation has awarded over $800,000 to Rush to build and staff the facility where clinical grade human cellular components can be developed to treat patients with certain cancers for Dr. Hans Klingemann, director of the section of Bone Marrow Transplantation and Cell Therapy at Rush.
"This facility will be like a pharmacy, but instead of dispensing drugs it will dispense cells," said Klingemann. "Immunotherapy -- using the patient's own cells to treat cancer -- is increasing and has proven to be very successful." Equally important, the Rush facility will comply with federal Food and Drug Administration's (FDA) new standards for Good Manufacturing Practice (GMP) and Good Tissue Practices (GTP). Referred to as a "clean room" facility, ultra sterile techniques including clean air circulation are required. This facility must have a specially trained staff experienced in clinical grade cell expansion procedures and familiar with meticulous procedure documentation according to GMP and GTP regulations.
"To perform sensitive human cell and tissue work, researchers need a clean room that meets these FDA regulations," said Richard Meagher, Ph.D., director of the Sramek Center. "We will accurately track each step and all actions that occur and will be able to recreate each component's manufacturing history from collection through infusion into the patient." Meagher said this facility would allow the Sramek Center to offer its services to area hospitals and biotechnology firms as an external lab to hand
Contact: Chris Martin
Rush University Medical Center