May 2010 Issue
Pressures to boost output, with lower short-term profits, will drive name-brand and generic companies alike to new technologies, and tools such as PAT. Or will they?
Feeding the minds of tomorrow's science-based professionals . . . with cookies.
According to a recent Ernst & Young Report, Big Pharma, while struggling to prosper in both the Pharma 1.0 business model, and the Pharma 2.0 model has been surpassed by a "Pharma 3.0 ecosystem."
DSM Pharmaceutical Products has found that "going green" in its processes is easy to justify from a cost standpoint and gives it a competitive advantage.
Leveraging PAT and QbD promises significant environmental dividends
Should improved process control or safety measures extend a product's patent exclusivity?
Ensuring effective asset management requires a clear and systematic equipment failure coding system.
A gradual transition to better C&Q practices is warranted, as is "getting rid of wasteful, bureaucratic practices that have developed over the years," says Abbott's David Dolgin.
Improvements in yields and reductions in waste are key reasons.
Certification is open to all excipient manufacturers, whether or not the excipient is compendial.
Common practices, including the selection of model organism, reflect lack of process knowledge. Are they driven by science, irrational fear, or marketing?
With real-time, wireless and other new monitoring technologies, pharma gains better control of temperature, pressure, humidity, and more.