Pharmaceutical Technology-11-02-2003

Pharmaceutical Technology

FDA Will Drive Changes for Contract Business

November 02, 2003

Articles

27

11

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

Articles

27

11

Pharmaceutical science & technology innovations.

Novemember 2003

November 02, 2003

Articles

27

11

Pharmaceutical science & technology news

FDA Seeks Risk-Based Inspection Program

November 02, 2003

27

11

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

Articles

27

11

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.

November 2003

November 02, 2003

Articles

27

11

Pharmaceutical science and technology

Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators

November 02, 2003

Articles

27

11

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.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

Articles

27

11

The authors propose several models for independent evaluation of new excipients.

Improving Protein Capture for Transgenic Drug Processing

November 02, 2003

Articles

27

11

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.