BioPharm International, September 2006 - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

BioPharm International, September 2006
Columns and Departments
From the Editor in Chief: An All-or-Nothing Approach Could Tie FDA's Hands
By Laura Bush
Taking a purist stance is always tempting. It can, however, have unintended consequences.
Regulatory Beat: Biotech Firms Collaborate on Third-World Drug Development
By Jill Wechsler
There is growing support for new partnership arrangements that seek to expand drug research by reducing the financial risk for manufacturers.
StreetTalk: New Sheriff in Town at Pfizer
By Brian O'Connell
In case you haven't heard, Jeffrey Kindler, Pfizer's general counsel, is replacing long-time CEO Henry "Hank" McKinnell as the new head of the company. There is a long-range strategy in naming a lawyer to run a drug company and I'll get to that in a moment.
Operations Excellence: Managing Your Suppliers for Maximum Results
By Marc Puich
Better supplier management can begin in parallel to production-related improvements.
Featured Article
Designing a Shorter Vertical Leg for Sanitary Steam Traps
By George W. Page, Jr. , Richard Kral
Steam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L.
Articles
A Systems-Based Team Approach to GMP Compliance
By Ron Johnson , Maxine Fritz
Companies faced with real or threatened FDA sanctions are usually least prepared to react effectively.
Chinese Biopharm Investment Moves Rapidly Up the Value Chain
By Joshua Brandt
China is becoming a much more sophisticated economy, with a large and well-educated workforce.
The Confusion Around COTS
By Richard Wagner
Increasingly, pharmaceutical companies have recognized that software development is not their core competency.
A Guide for Testing Biopharmaceuticals Part 1: General Strategies for Validation Extensions
By Stephan Krause, PhD
Good risk management tools dictate how much assay performance characteristics can deviate from ideal.

ADVERTISEMENT

ADVERTISEMENT

Click here