BioPharm International, October 2008 - BioPharm International

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BioPharm International, October 2008
Features
Where is Biopharmaceutical Manufacturing Heading?
By Gunter Jagschies, PhD
An analysis of current and upcoming industry challenges.
Biopharmaceuticals: Approval Trends in 2007
By Gary Walsh, PhD
The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.
Detection of Cache Valley Virus in Biologics Manufactured in CHO Cells
By Raymond W. Nims, PhD , Sandra K. Dusing, PhD , Wang-Ting Hsieh, PhD , Archie Lovatt, PhD , G. Gordon Reid, PhD , David Onions, PhD, FRSE , Euan W. Milne
Avoid manufacturing failures by effective viral inactivation.
Columns and Departments
Strengthening the Chain: Addressing Pedigree Challenges Across Outsourced Operations
By Todd Applebaum , Scott Dicks , Frank Gaibor
Despite the current regulatory uncertainty, pharmaceutical companies should move forward with planning for serialization and pedigree.
FDA Promotes QbD for Biotech Therapies
By Jill Wechsler
The FDA's QbD pilot program is supporting good manufacturing on a global basis.
Disposable Decisions
By Uwe Gottschalk, PhD
To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.
Biotech Cruises On Despite a Turbulent Economic Climate
By G. Steven Burrill
The biotech industry's year-to-date report card contains good grades despite the turbulent economic climate.
Pharmaceutical Distribution in India
By Abhijeet Kelkar , Eric S. Langer
The rapid growth of the pharmaceutical industry in India is yet to create significant changes in the Indian distribution system.
Sick Economy, Sick Healthcare System
By Laura Bush
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.

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