June 2006 Issue


  • Dismantling the Gray Maze

    A bureaucratic drug regulatory system — once referred to as a “gray maze” — has long isolated the world’s second largest pharmaceutical market from the rest of the world. Japan’s regulators are moving toward an international, science-based framework. Can they move fast enough? Agnes Shanley interviews ICH founder Dr. Osamu Doi and experts in regulatory affairs, for their views on what the future holds.

  • Aseptic Processing, the Japanese Way

    With inspired robotics and isolation technology, Japan is pushing the aseptic processing envelope. James Akers and colleagues from Shibuya and Handai Biken assess what sets Japan apart, and take us inside Handai Biken’s vaccine facility for a look at what the future may have in store for more drug manufacturers.

  • From the Editor: Japan Globalizes, But Won’t Compromise on Core Values

    Japan has embraced ICH, but doesn’t yet have any official “mutual recognition” policy with FDA regarding GMP inspections. The nation also maintains a unique position on clinical trials, which influences many drug manufacturing decisions. Can genomics resolve a highly politicized issue? MIT scholar Dr. Wen-Hua Kuo shares his insights.

  • RFID Battles the Elements

    Metal can be friend or foe. Water is always troubling. And even glass and plastic can impede success. Making RFID work in a pharmaceutical setting takes materials and packaging expertise, and a little black magic. We survey the experts on what they know, and what they don’t.

  • Personalized Medicine: Immunotherapy Vaccines

    Named for the natural way its therapies work, with the body’s own processes, a Japanese manufacturer called Green Peptide is focusing on treating cancer and providing patients with a better "quality of life" alternative to chemotherapy or radiation therapy.