BioPharm International-11-01-2002

by Jim Miller and Janet Lowenbach, PharmSource Information Services The EU must harness market forces that reward innovation and competitiveness to combat its current R&D drain.

Columns and Departments

November 15, 2002

by Jill Wechsler A new FDA commissioner will have to oversee agency consolidation and new initiatives to counter bioterrorism.

Passing Inspections & Protecting Your Work

November 15, 2002

by Elizabeth Howard and Gabriel Ramsey, Orrick, Herrington & Sutcliff With some planning, you can use intellectual property laws to adequately protect the wealth of data stored in your databases. Those valuable data may not be copyrightable, but the software used to store them is.

BioPharm Scale-Up: Going International

November 15, 2002

by Kevin Robinson, BioPharm International As we approach the end of 2002, biotechnology companies continue to be the standard bearers for innovation in the pharmaceutical industry.

Columns and Departments

November 15, 2002

by Stefan Schuber, U.S. Pharmacopeia

by S. Alison Arnold, Linda M. Harvey, and Brian McNeil from the Strathclyde Fermentation Center, Strathclyde, Scotland; and Jeffrey W. Hall, Foss NIRSystems Although rarely available, timely process information about fermentation biomass, substrates, intermediates, and nutrients is required to make control decisions. NIR spectroscopy offers the opportunity to improve fermentation processes by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth media directly into fermentation monitoring and control strategies.

Passing Inspections & Protecting Your Work

November 15, 2002

by Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.

Passing Inspections & Protecting Your Work

November 15, 2002

by Massoud Lavian and Paul W. Allen, Clarkston Consulting

by Gary Schultz, Advion BioSciences