BioPharm International, July 2005 - BioPharm International

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BioPharm International, July 2005
Columns and Departments
StreetTalk: With Nanotechnology, It's the Little Things that Count
By Brian O'Connell
I was playing tennis recently with my friend Ron who, in addition to a wicked backhand, is well-versed in new technologies and gadgets.
Editorial: Partnerships: For Better or for Worse
By Carol L. Fisher
One of the very last sessions on the very last day of BIO 2005 drew quite a crowd. It was titled, "The Five Worst Mistakes You Can Make When Creating a Collaboration or Strategic Alliance."
Regulatory Beat: Vaccine Manufacturers face New Opportunities, Additional Scrutiny
By Jill Wechsler
FDA plans to conduct good manufacturing practices (GMP) inspections of flu vaccine manufacturers annually instead of every two years.
Final Word: New Jersey: Biotech's Ideal Lab Location
By Debbie Hart
As the fourth largest center for biotechnology and life sciences in the US, New Jersey is home to 15 of the world's 20 largest pharmaceutical companies. More than half of all new medicines approved in the US are developed by New Jersey companies. New Jersey is an ideal location because it offers close proximity to the financial markets in New York and Philadelphia, and a highly skilled workforce, strong funding, government support, and academic expertise.
Articles
Stop rejecting Good Batches - Use a Signal-to-Noise Transformation
By James McAllister
When data are not normal, a more efficient approach to monitor and control the performance of this assay requires transforming the data to a normal distribution. One of the most useful transformations was invented by Taguchi.
Disposables Solve Tomorrow's Manufacturing Problems
By Ian Sellick , Holly Haughney, Ph.D
Disposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.
Forced Degradation Studies: Regulatory Considerations and Implementation
By Michael Kats, Ph.D.
The manufacturer should propose stability-indicating methodologies that provide assurance that changes in the identity, purity, and potency of the product will be detected.
Leveraging Asset Performance Management in Pharmaceutical Manufacturing
By Matt Langie
Web-based asset performance management provides pharmaceutical manufacturing with a number of advantages over traditional asset maintenance and tracking.
Special Section
Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case Report
By Rene Brecht, Ph.D. , Volker Sandig, Ph.D. , Susan Koch , Uwe Marx, Ph.D. , Marco Riedel, Ph.D.
Cell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.

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