BioPharm International, December 2007

Features

Quality by Design in the CMO Environment

By Susan Cook , Katherine A. Patton , L. Rochelle Bazemore, PhD

How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.

Developing a Sound Process Validation Strategy

By David M. Fetterolf

Developing a process validation strategy early in clinical development is critical for a successful validation program.

Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 2

By Balazs Hunek , Alan Cheng, PhD , John Capettini

The second of a two part article.

Columns and Departments

Taking a Closer Look

By Laura Bush

Many companies acknowledged that Western regulatory standards are tougher than those in China.

Life Sciences and Socially Responsible Investing

By Brian O'Connell

More than $1 out of every $9 under professional management in the United States is involved in socially responsible investing.

Has the Era of Blockbuster Drugs Come to an End?

By Nafees Malik

Eighty drugs will lose patent protection between 2007 and 2011.

China as a Biopharmaceutical Powerhouse: Just a Matter of Time

By Eric S. Langer

China's pharma industry represents 5% of the world total. By 2010, China is expected to become the world's fifth largest pharmaceutical market.

Personalized Medicine May Rationalize the Coverage of Specialty Therapies

By Jill Wechsler

The personalized medicine bandwagon is on a roll, offering a new model for calculating reimbursement of high-cost biotech therapies. Strategies for identifying patients who will respond to a certain therapy, as well as those most likely to suffer adverse events, promise to improve healthcare quality while eliminating waste and inappropriate spending. Interventions based on individual genetic characteristics may have limited sales, but support higher prices and less costly clinical research methods.