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.