[Education of laboratory technicians at graduate school contributes to development of advanced medical sciences and therapeutics]

Abstract

Translational research for novel cell and molecular therapy requires high scientific and ethical standards throughout the manufacturing of clinical trial material according to ICH-GCP (International Conference on Harmonization-Good Clinical Practice) guidelines. Advanced cellular therapy development such as cell transplantation, adoptive immunotherapy, gene therapy and regenerative therapy mandate cGMP (current good manufacturing practices)-grade cell processing to assure the safety and quality of manipulated cell products. One of the first steps in cGMP conversion from the bench to the clinic is the design of a facility for the preparation of clinical material for use in human trials. The establishment of regulatory guidelines for cell processing to develop advanced cellular therapies is clearly needed. In addition, one of the important matters in the organization and management of advanced cell therapeutic centers for academia, is how to educate and train sophisticated technicians specialized for GMP regulations and GMP-graded cell processing. Such technicians should be educated at a graduate school of medicine for health science. GMP-cell processing is an active field for such graduates.