Abstract
Translational research requires the high scientific and ethical quality throughout clinical trails according to the ICH-GCP guideline. Cell therapy includes blood transfusion, stem cell transplantation, adoptive immunotherapy, gene therapy, and regenerative therapy. GMP (Good Manufacturing Practice)-graded cell processing such as cell preparation, culture, manipulation, labeling, storage, and shipping is mandatory for the progress of such advanced cell therapy. One of the first steps in cGMP conversion from bench to clinic is designing facility for preparation of clinical material to be used in human trials. However, cGMP-graded cell processing has a number of different points compared with the conventional GMP for drugs. Since we have no definite and detailed rules yet in Japan how to prepare cell products for advanced cell therapy and how to design these cell processing facilities, we have to establish these rules as soon as possible in collaboration with physicians, technicians, engineers, pharmacists, GMP consultants, and government officials in order to make an appropriate progress of translational research for cell therapy. Considerations important for the development of cGMP-graded cell processing are discussed.
