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Book Review: Advances in Biopharmaceutical Technology in China

April 1, 2007

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.

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.

Disposables: Keeping Pace with Today's Disposable Processing Applications

April 1, 2007

Frequently asked questions on implementing and using single-use technologies

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).

Manufacturing: BioPharmaceutical Operations Roadmap 2007

April 1, 2007

Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.

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.

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.

CMC Strategy Forum Takes on Glycosylation

March 22, 2007

The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship.

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