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.
Pharmaceutical science & technology innovations.
Pharmaceutical science & technology news
FDA's new policies intend to make GMP inspections more efficient and apply to stricter rules to high-risk products and processes.
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.
Pharmaceutical science and technology
FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.
The authors propose several models for independent evaluation of new excipients.
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.
