BioPharm International-10-01-2008

The country is reeling from US Treasury Secretary Henry Paulson's proposed $700 billion Wall Street bailout. In appealing for support, Paulson stressed this was a crisis. This sense of urgency is reminiscent of the way millions of Americans without health insurance cope with medical problems-in the emergency room, because they have no access to routine and preventive care.

The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.

An analysis of current and upcoming industry challenges.

Avoid manufacturing failures by effective viral inactivation.

To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.

The rapid growth of the pharmaceutical industry in India is yet to create significant changes in the Indian distribution system.

The FDA's QbD pilot program is supporting good manufacturing on a global basis.

The biotech industry's year-to-date report card contains good grades despite the turbulent economic climate.

Despite the current regulatory uncertainty, pharmaceutical companies should move forward with planning for serialization and pedigree.