Article - BioPharm International

ADVERTISEMENT

Article

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.

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.

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.

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.

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.

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.

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.

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.

ADVERTISEMENT

ADVERTISEMENT

Click here