BioPharm International, May 2006 - BioPharm International

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BioPharm International, May 2006
Featured Article
Regulatory Gaps Regarding Sugars Used in Injectable
By Tom Biere
The sugars used to stabilize lyophilized proteins often have not been subjected to appropriate cGMP standards.
Articles
Facility Design and Expansion: Commissioning for Innovation
By Mark N. Yakren, PE
Once guiding principles are identified, designers can explore the most cost-effective methods for delivering a flexible, expandable site.
Maximizing Protein Expression in Filamentous Fungi
By Richard P. Burlingame, PhD , Jan C. Verdoes, PhD
One of the major challenges in fungal biotechnology is preventing proteases of the fungi from degrading recombinant proteins.
Best Practices in Demand and Inventory Planning
By Chris Taunton, PhD , Jonathan Feinbaum
The foundation of a sound supply chain planning infrastructure requires implementing a strong, systematic forecasting process.
Columns and Departments
Final Word: Creative Solutions Can Ensure Pandemic Flu Preparedness
By Nipon Das, MD
Certain areas of the vaccine market appear to be in vogue again, revitalized by blockbusters such as Prevnar, the pneumococcal pneumonia vaccine that reaped $1.5 billion in sales last year, and the human papilloma virus vaccines, which are projected to reach $4 billion per year.
From the Editor in Chief: Engineering Oneself Out of a Job
By Laura Bush
Alexander Fleming's original process for making penicillin was a low-volume, and presumably, labor-intensive affair. Today, it is a highly optimized, low-budget operation that is carried out only overseas. In other words, says Wei-Shou Hu, PhD, of the University of Minnesota, we engineered ourselves out of a job. Could we do the same with mammalian cell culture? Hu posed this question during a presentation at the BIO conference in April.
StreetTalk: Investments in Avian Flu Soar
By Brian O'Connell
The federal government plans to spend $3.3 billion on bird flu initiatives, about half of that on a vaccine.
Regulatory Beat: FDA Encourages Innovation in Biotech
By Jill Wechsler
The Food and Drug Administration recently unveiled its long-awaited Critical Path Opportunities List, which maps out a number of "scientific projects" for improving the testing and production of biotech therapies. In its March report, FDA recognizes that problems in the characterization, testing, and quality management of medical products can delay clinical trials and even completely block drug development.
Letters to the Editor
After reading Brian O'Connell's column in the February 2006 issue of BioPharm International, entitled, "Will Venture Capital Firms Turn Their Backs on Stem-Cell Research?" one would like to comment. The press is too fascinated by Dr. Hwang's scientific misconduct, which was discovered, and sanctions imposed.
Legal Forum: Drug Product, Active Ingredient, and Patent Term:
By Judy M. Mohr, PhD
Only the product that served as the basis of the extension is exclusively covered by the patent during its extended term.
Event Coverage
Accept No Limits on Mammalian Cell Expression
Instead of investing in new facilities, the industry should focus on improving manufacturing technology to increase yields, says Timothy Charlebois, PhD, director of cell and molecular sciences for Wyeth (Madison, NJ, www.wyeth.com). Charlebois made these remarks in his introduction to the session, "Frontiers and Economics of Mammalian Cell Expression," at the BIO 2006 convention."I've seen examples where we took a process that produced 3 grams of protein per liter, and were able to optimize it so that it produced 9.6 g/L," he said, adding that future yields are likely to be above 10 g/L.
Interphex 2006 Coverage New Facilities: From Groundbreaking to Validation in 25 Months
By Laura Bush
In the biotech industry, everyone wants to get to market fast. But what if you have to build a manufacturing facility first? At Interphex 2006, Roger Lias, PhD, vice-president of sales and business development at Cytovance Biologics (Oklahoma City, OK, www.cytovance.com), explained how his company did it quickly. In August of this year, the company expects to complete validation of a new cGMP contract manufacturing facility for biopharmaceuticals derived from mammalian cell culture ? just 25 months after the original groundbreaking.

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