January 2010 Issue
Xcellerex offers companies a way to hedge the risk of building new drug facilities.
Next Fall, Novavax expects to move to Phase III testing of its seasonal flu vaccine. In the meantime, its refining a manufacturing process that uses disposable process equipment to minimize risk, cost and plant footprint. VP Jim Robinson discusses the companys plans.
Pharma may not be adopting PAT and QbD wholesale, but smaller, more powerful hardware offers a glimmer of hope.
Theres a burgeoning market out there for products that can help manufacturers monitor complex bioprocesses.
Follow-on biologics regulation could stifle the innovation that defines and drives the biopharmaceutical industry, say two of Deloittes leading experts in the area.
Thoughts on beta-testing the Google Wave? A little fishy.
Compliance specialist Michael Gregor puts the spotlight on software validation, and tells us why FDA is doing the same.
Pharma tech transfer may be complex, yet it is often held up by simple problems such as failure to plan or share information
An interview with Eli Lilly Systems Engineer Dave Powers on his companys use of cloud computing.
By virtualizing its computing, Lilly can do more, with more people involved.
What dooms many tech transfer projects is a failure to communicate and plan.
Contamination mapping isnt exactly cartography, but it can be an effective troubleshooting tool.
Every sterile facility is unique, but a recent Jacobs study suggests that advanced isolation technology pays dividends in the long run.
For supply chain success, abandon dogma and seek a hybrid approach. McKinsey & Co.'s Knut Alicke, Christoph Karrer and Ulf Schrader explain.