Pharmaceutical Regulatory Affairs: Open Access

Shigetaka Shimodaira

Publications

• Short Article
  Future Prospective of Cancer Vaccination Technology in Japan
  Author(s): Shigetaka Shimodaira, Koichi Hirabayashi, Takashi Kobayashi, Yumiko Higuchi and Kiyoshi YokokawaShigetaka Shimodaira, Koichi Hirabayashi, Takashi Kobayashi, Yumiko Higuchi and Kiyoshi Yokokawa
  
  Dendritic cell (DC)-based immunotherapy has been developed against various types of cancers. To develop and promote regenerative medicine and cell therapy in Japan, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law have been enforced since November 25, 2014. Therapeutic vaccination with active DCs was evaluated under the legal framework. Cancer vaccination therapies with autologous monocyte-derived mature DCs are principally attributed to the presence of tumor-associated antigens. Clinical studies and trials should be conducted in accordance with legislation for approval of either DC-based cancer therapy or DC vaccine products. The following issues with regards to DC-based vaccination and vaccine products for clinical use may be raised: 1) Manufacturing of DCs according to the standard grade of Good Gene, Cellular, and Tissue-based Products (GCT.. Read More»
  DOI: 10.4172/2167-7689.1000143

  Abstract PDF