Quality Assurance in Ex Vivo Progenitor Cell Manipulation

Abstract

Over the past few years, hemopoietic transplant has evolved from an investigational phase to routine therapy, thus becoming a potentially curative strategy for a large variety of diseases. Several transplant situations are still outstanding and the need for ex vivo graft manipulation for different transplantation products is growing. To obtain an ideal graft, many different methods, even sophisticated manipulations, may 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 these new manipulated hematopoietic products is very complex and should come under current Good Manufacturing Practices (cGMPs). Manufacturing approach to these new blood products must be urgently introduced to accounting Quality System in Transfusion Medicine. The best way to develop compliance with standards, in agreement with internationally accepted criteria, is, likely, an accreditation system in transplantation programs.