QUALITY ASSURANCE IN EX-VIVO PROGENITOR-CELL MANIPULATION

Over the past few years, hemopoietic transplant has evolved from an in vestigational phase to routine therapy thus becoming a potentially cur ative strategy for a large variety of diseases. Several transplant sit uations are still outstanding and the need for ex vivo graft manipulat ion for different transplantation products is growing. To obtain an id eal graft, many different methods, even sophisticated manipulations, m ay be required. Since transplantation products play an important role in disease outcome, the assessment of graft quality to ensure standard compliance is needed. The development of a regulatory approach to the se new manipulated hematopoietic products is very complex and should c ome under current Good Manufacturing Practices (cGMPs). Manufacturing approach to these new blood products must be urgently introduced to ac counting Quality System in Transfusion Medicine. The best way to devel op compliance with standards, in agreement with internationally accept ed criteria, is, likely an accreditation system in transplantation pro grams.