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IP Briefs: The Positive Side of Negative Disclaimers

June 1, 2007

Addition of a disclaimer to a claim, based on words not present in the application as filed, is referred to as an undisclosed disclaimer.

China Today: Biogenerics in China: An Evolving Industry

June 1, 2007

In China, the presence of a substantial biogenerics industry reflects a growing need to provide healthcare to domestic populations, at a reasonable cost.

From the Editor: On the Cusp of Profitability

June 1, 2007

Without charges for some large merger deals, the publicly traded US biopharmaceutical industry would have been profitable in 2006—for the first time.

Final Word: Outsourcing in Today's Risk-Based Environment

June 1, 2007

Outsourcing has been a cornerstone of our industry for decades.

Facility Design: Simulation Methodology for Facility Design

June 1, 2007

Discrete simulation allows the design teams to see every meaningful detail about equipment and materials flowing through the process.

Disposables: Biopharmaceutical Disposables as a Disruptive Future Technology

June 1, 2007

Today, most disposables are used for process development and clinical-scale manufacturing. Substantial growth in disposables usage may not occur until disposables are incorporated into the production of licensed products at commercial scale.

FDA Moves to Streamline GMP Inspections

June 1, 2007

FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.

Advances in Animal-Free Manufacturing of Biopharmaceuticals

May 2, 2007

In addition to existing guidance, in January 2007 the FDA announced further proposals to prohibit the use of certain bovine materials as ingredients in some medical products or as elements of product manufacturing.

Rapid High-Throughput Feed Optimization

May 2, 2007

Growth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.

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