BioPharm International, July 2005

Columns and Departments

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.

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."

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.

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.

Articles

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.

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.

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.

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.

Feature Articles

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.