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.
Once guiding principles are identified, designers can explore the most cost-effective methods for delivering a flexible, expandable site.
The sugars used to stabilize lyophilized proteins often have not been subjected to appropriate cGMP standards.
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.
One of the major challenges in fungal biotechnology is preventing proteases of the fungi from degrading recombinant proteins.
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.
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.
Only the product that served as the basis of the extension is exclusively covered by the patent during its extended term.
The foundation of a sound supply chain planning infrastructure requires implementing a strong, systematic forecasting process.
The federal government plans to spend $3.3 billion on bird flu initiatives, about half of that on a vaccine.
