Abstract
Recent progress in recombinant DNA technology and cell culture technology has enabled us to produce new medically useful agents for gene therapy and cellular therapy. To enable these products to be of use in human therapy, it is essential that suitable measures be taken by the manufacturers and control authority to assure quality, efficacy, and safety. This article describes points, based on the latest sound scientific principles, to be considered for producing, testing, evaluating and controlling pharmaceutical products for gene therapy and cellular therapy, especially with respect to their quality and safety.
