Upstream Processing

Jun 01, 2006
BioPharm International
Transgenics can substantially reduce capital investment and lower production costs through economies of scale and more flexible scale-up.
Jun 01, 2006
BioPharm International
The belief that glycosylation is critical to ensuring the functionality of protein therapeutics—and preventing immunogenicity—drives many manufacturing decisions. But is it time to question this industry tenet?
May 01, 2006
BioPharm International
By BioPharm International Editors
The federal government plans to spend $3.3 billion on bird flu initiatives, about half of that on a vaccine.
May 01, 2006
BioPharm International
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.
May 01, 2006
BioPharm International
One of the major challenges in fungal biotechnology is preventing proteases of the fungi from degrading recombinant proteins.
May 01, 2006
BioPharm International
By BioPharm International Editors
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.
May 01, 2006
BioPharm International
By BioPharm International Editors
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.
Mar 10, 2006
BioPharm International
By BioPharm International Editors
As we've shown, biopharmaceutical companies have many options when they choose an expression system: bacteria, yeasts, insect or mammalian cells, and transgenics. Each system has its advantages and disadvantages. Company decision makers must ask themselves several important questions: How much product must be made? How complex is the molecule? Does it require posttranslational modifications to be biologically active? The expression system determines what kind of contaminants will be present and in what quantities. It also determines economic factors: the time scales involved, expression levels obtained, and various regulatory issues. Each potential expression system must be evaluated for its ability to produce economically the maximum amount of biologically active product. Purification methods may be different for products that come from the different host systems. And regulators are more familiar with some systems than with others.
Mar 10, 2006
BioPharm International
By BioPharm International Editors
Many of these terms have more general definitions as well. Those given here are specific to their application in cell culture and fermentation.
Mar 10, 2006
BioPharm International
By BioPharm International Editors
At the heart of modern biotechnology is the ability to manipulate DNA, the astonishing molecule that contains the genetic code of all life on earth. But fermentation and cell culture are also the practical art of keeping cells alive and growing in an artificial environment. As a result, the science of cell culture also includes a healthy focus on the natural processes that keep cells alive.
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