June 2006 Issue
PAT and advanced process control are gaining acceptance, but adoption of open control and the latest control strategies are still years away for some.
A bureaucratic drug regulatory system once referred to as a gray maze has long isolated the worlds second largest pharmaceutical market from the rest of the world. Japans 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.
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 Bikens vaccine facility for a look at what the future may have in store for more drug manufacturers.
Japan has embraced ICH, but doesnt 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.
Transgenics offers significant process advantages both upstream and down, but few companies are willing to take on biotechs entrenched culture.
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 dont.
Named for the natural way its therapies work, with the bodys 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.
New equipment isnt always an option, and used is losing its stigma.
Process Analytical Technology, CFD and microscopy can help ensure that crystallization scale-up is right the first time.