BioPharm International, August 2008 - BioPharm International

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BioPharm International, August 2008
Features
A Rational Approach for Setting & Maintaining Specs for Biological & Biotechnology–Derived Products—Part 3
By Timothy Schofield , Izydor Apostol, PhD , Gerhard Koeller, PhD , Susan Powers, PhD , Mary Stawicki , Richard A. Wolfe, PhD
Set limits to provide incentives for process improvements.
Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit Operation
By Oliver Kaltenbrunner , Justin McCue , Philip Engel , Jorgen M. Mollerup , Anurag S. Rathore, PhD
A review of some recent contributions in process chromatography.
Columns and Departments
Connecting the Manufacturing Process to Patient Wellness
By Kim Thomas , Darren Hieber
Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.
The Visible Hand: Government Supports the Biopharmaceutical Industry
By Eric S. Langer
What the Indian government is doing to make its biotech sector as strong as its IT sector.
GMPs in Phase 1: Take 2
By Laura Bush
GMPs in Phase 1 is more important now than ever before.
Disposables Open Up Possibilities in Facility Design
By Andrew Sinclair , Miriam Monge
In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.
FDA Seeks Active System for Monitoring Adverse Events
By Jill Wechsler
The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.

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