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