Pharmaceutical Technology-11-02-2003
Pharmaceutical Technology
FDA Will Drive Changes for Contract Business
November 02, 2003
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As FDA tries to bring pharmaceutical manufacturing into the 21st century, competitive dynamics in contract manufacturing are likely to change in favor of companies that have greater manufacturing expertise and the means to invest in new technologies.
In the Spotlight--December
November 02, 2003
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Pharmaceutical science & technology innovations.
FDA Seeks Risk-Based Inspection Program
November 02, 2003
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FDA's new policies intend to make GMP inspections more efficient and apply to stricter rules to high-risk products and processes.
Routine Sample Size for a Retest Procedure
November 02, 2003
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This article discusses a straightforward approach that scientists may use to descide how many nonsuspect restest results are required to provide sufficient evidence to overcome an initial suspect result.
Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators
November 02, 2003
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FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.
Clearing Regulatory Hurdles
November 02, 2003
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The authors propose several models for independent evaluation of new excipients.
Improving Protein Capture for Transgenic Drug Processing
November 02, 2003
Articles
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One of the greatest challenges facing biopharmaceutical manufacturers has been the primary recovery of recombinant materials from transgenic sources. As an alternative to existing methods, vibrating membrane technology, which is widely used in food and beverage processing, recently has been adapted to biopharmaceutical applications involving transgenic biosolutions.