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China Today: Vaccine Development in China

April 1, 2007

The Chinese vaccine market competition is now transferring from the former price-competition model to a technology- competition model.

Disposables: Keeping Pace with Today's Disposable Processing Applications

April 1, 2007

Frequently asked questions on implementing and using single-use technologies

From the Editor: Focus on What Matters

April 1, 2007

Financial pressure to show short-term results also affects the pharmaceutical industry, from Big Pharma to small biotech.

Quality: Design Space for Biotech Products

April 1, 2007

Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.

Regulatory Beat: FDA Moves to Streamline Manufacturing Supplements

April 1, 2007

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.

Filtration:Vendor Notes: The Effect of Flux Decay on a 20-nm Nanofilter for Virus Retention

April 1, 2007

Although contaminants and other parameters may be main causes of filter breakdown, some nanofilters still remove viruses at high Log Reduction Value (LRV).

Final Word: Is Building Biotech an Economic Magic Potion?

April 1, 2007

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.

CTI Forms Aequus to Develop Alternative to PEGylation

March 22, 2007

Cell Therapeutics, Inc. (CTI, Seattle, WA, www.ctiseattle.com), has formed a new spin-off company, Aequus BioPharma, Inc., to develop a novel process to extend the half-life of proteins.

USP Seeks Participants for Glycan Analysis Study

March 22, 2007

The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides.

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