New Technologies Improve Biotech's Downstream Processing

Author: Rebecca Andrews, p. 24, 25.

Over the last few years, the number of recombinant pharmaceutical products that have entered the regulatory fray to gain approval for marketing has grown rapidly, and is now in the hundreds. As biotechnology companies seek regulatory approval for their products, however, they also face the problem of producing these proteins in quantity, at an affordable cost.

Downstream processing is the isolation and purification of a desired protein from the soup of bacterial or animal cells that produced it. This stage, so termed because it takes place "downstream" from the production process, is "the rate-limiting step in the release of biotech products," says Bob Kennedy, applications lab manager at Membrex Inc., a Fairfield, N.J., company that specializes in membrane filtration systems. "Science and economics meet head to head."

Kennedy points out that the actual production of recombinant proteins typically...

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