Cell and vector production facility for gene therapy and cell therapy

Abstract

Approximately 25 years has passed since the fi rst clinical study of gene therapy was performed, and many good results have been reported in the last 10 years. However, Japan shows a remarkable delay compared with the West in the clinical application of gene therapy, and one reason is that organizations manufacturing bioproducts for conducting high-quality clinical studies have not been fully established in Japan. Recently, the Japanese government introduced the Regenerative Medicine Promotion Acts for accelerating the implementation of “Regenerative Medical Products” including gene therapy and cell therapy. These Acts allow the outsourcing of the production of drug products used for clinical research and also the cell processing which were previously only permitted to do at clinics. We have now constructed a large-scale facility for cell and vector production for gene therapy and cell therapy as a CDMO (Contract Development and Manufacturing Organization), which provides clients with comprehensive services from drug development through manufacture, based not only on Japanese GMP but also on cGMP, EU GMP, and other related regulations and on the Cartagena Act to prevent the dispersal of living modifi ed organism.