BioPharm International, August 2009 - BioPharm International

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BioPharm International, August 2009
Cover
Embedding a Culture of Continuous Improvement & Lean Manufacturing Across Pfizer Global Manufacturing
By Gerry Migliaccio , John Scott
Enabling site-wide process efficiency.
Features
Use of Change-Point Analysis for Process Monitoring and Control
By Patrick Gavit , Yasser Baddour , Rebecca Tholmer
A better method for trend analysis than CUSUM and control charts.
Analytical Tools for Process and Product Characterization
By Brent S. Kendrick, PhD , Greg Chrimes , Steven L. Cockrill, PhD , Kelly K. Arthur , Brad D. Prater , Qiang Qin, PhD , Bing Zhang , Anurag S. Rathore, PhD , John P. Gabrielson
Select the best approach to determine critical quality attributes.
Manufacturing Economics Series
Garbage In, Garbage Out: The Case for More Accurate Process Modeling in Manufacturing Economics
By Rick Johnston , David Zhang
A case study in capturing indirect costs and benefits.
Regulatory Beat
Health Reform Challenges Biotech Industry
By Jill Wechsler
Pressures to reduce healthcare spending generates proposals to spur competition, cut costs.
Outsourcing Insights
Waiting for Godot: Will Venture Funding Return?
By Jim Miller
Contract research, development, and manufacturing organizations betting on a comeback in venture capital financing will have a long wait.
Final Word
Recent Patent Rulings Can Impede the Progress of Personalized Medicine
By Michael R. Samardzija, PhD
The Bilski and Classen decisions can render numerous in vitro diagnostic claims unpatentable.
From the Editor
Laying the Foundation
By Laura Bush
Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.
Disposables Advisor
The Role of Disposables in Rapid Response Manufacturing
By Andrew Sinclair , Miriam Monge
Single-use technologies can be configured and installed fairly quickly, but are they ready to handle the urgency and scale of a pandemic?
Expression Systems
Avoiding the Regulatory Catch 22
By Eric S. Langer
Companies often wait for a critical mass before adopting new technologies. But if no one takes the risk, critical mass will never be reached.

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