BioPharm International, April 2007 - BioPharm International

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BioPharm International, April 2007
Features
Quality: Design Space for Biotech Products
By Anurag S. Rathore, PhD , Ron Branning , Doug Cecchini
Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.
Manufacturing: BioPharmaceutical Operations Roadmap 2007
By Marc Puich
Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.
Filtration:Vendor Notes: The Effect of Flux Decay on a 20-nm Nanofilter for Virus Retention
By Klaus Tarrach , Anika Meyer , Julia Elena Dathe , Hanni Sun
Although contaminants and other parameters may be main causes of filter breakdown, some nanofilters still remove viruses at high Log Reduction Value (LRV).
Disposables: Keeping Pace with Today's Disposable Processing Applications
By Hélène Pora
Frequently asked questions on implementing and using single-use technologies
Columns and Departments
Final Word: Is Building Biotech an Economic Magic Potion?
By K. John Morrow, Jr., PhD
Virtually every corner of the United States (not to mention the rest of the world) seeks to build a powerful biotech presence (see www.bio.org/local/). Since the dawn of biotechnology in the mid 1970s, private venture capital, major corporations, and state and federal governments have poured hundreds of billions of dollars into the industry. Results have been mixed, in terms of benefits to local economies and products that reached the marketplace.
Book Review: Advances in Biopharmaceutical Technology in China
By Steven S. Kuwahara
This 1,230-page tome is a must-have encyclopedia for any person or organization planning to interact with the biopharmaceutical market in China. It contains 23 well-written chapters and five appendices written by individuals who are experts in the areas they address. Some of these experts are not well known in the US; thus the book also provides an excellent introduction to people whose knowledge and opinions are important when considering biopharmaceuticals in China. Many chapters were translated from Chinese and this is the first time that their information has been provided to the West.
Regulatory Beat: FDA Moves to Streamline Manufacturing Supplements
By Jill Wechsler
The challenge will be to design a system that is flexible, yet appropriate, for the broad range of biological products and the varying quality control capabilities of different manufacturers.
China Today: Vaccine Development in China
By Eliza Yibing Zhou
The Chinese vaccine market competition is now transferring from the former price-competition model to a technology- competition model.
From the Editor: Focus on What Matters
By Laura Bush
Financial pressure to show short-term results also affects the pharmaceutical industry, from Big Pharma to small biotech.

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