Maryland Technology Enterprise Institute

Mtech Press Releases

MEDIA ADVISORY
October 1, 2004

UM Bio Lab Unveils Upgrades to Serve Next Generation of Biotechnology Companies

COLLEGE PARK, Md.—The University of Maryland's Bioprocessing Scale-Up Facility, which helped usher in Maryland's biotechnology era, unveiled major upgrades yesterday to serve the next generation of biotechnology companies.

The facility, launched in 1985, helps companies take bench-top or lab-produced products and prepare them for mass production. The facility also creates biological products in-house and ships them to companies and laboratories.

Upgrades for the BSF, which will enable it to make purified pharmaceutical- and drug discovery-grade proteins, were funded by a $775,000 grant from the Maryland Department of Business and Economic Development.

The enhancements will also train teams of students in the latest techniques of biotechnology production.

"It's fair to say the majority, if not 100 percent of any of the 350 or so biotech companies in the state that have reached production or have any kind of repeatable process have had their process engineers trained at this facility," said Aris Melissaratos, secretary of DBED. "So when it was time to upgrade this facility, it was a no-brainer--it’s spending just a little bit of money compared to the power it might have to grow our industry."

The BSF directly spurred the growth of many biotechnology companies when they were in their infancies, including Martek Biosciences Inc., Digene Corporation, and MedImmune, Inc.--by not only working with them on making products, but also by teaching them how to produce them at a large scale. The lab also produced materials for government laboratories such as the National Institutes of Health, the National Institute of Standards and Technology, and the U.S. Army.

"When I came to Ed Sybert [industry director of the BSF] 10 or 12 years ago, Martek had developed this fermentable algae," said Henry "Pete" Linsert, chairman and CEO of Martek. "We were getting into the next stage where we said 'will this stuff actually scale-up?' If it doesn’t scale up, we thought, if the economics aren't good, if it doesn't make pure products, if the organism doesn't grow well--we're sunk. We didn't have the equipment; we didn't have the people. Ed said let's see if we can make this work. And it did!

"Over 6 million babies have now had this material," Linsert continued. "Over 70 percent of the infant formula in the United States has it. It all started here. It all came from this facility."

The BSF has conducted more than 700 fermentations for companies and labs since 1998, when the facility started tracking those numbers. Fermentation, a specific type of bioprocessing, is the method of growing microorganisms to make chemical or pharmaceutical compounds. Microbes are incubated under specific conditions in large tanks called fermenters.

"Any kind of facility you have that’s treating 50 to 60 companies a year, helping them develop new processes that can lead to actual production drugs and other biotechnology products, shouldn’t have been as well a kept secret as it was," said University of Maryland Provost William Destler. "The changes that have been made here are not just some bio-related conversion of a reactor. They actually represent new capabilities for our own biotech businesses. We can now produce manufacturing-grade products, and we can do so at a purity we could never do before. It's a revolution in the quality of services we can provide to support the state's biotechnology industry."

Many of today's biotechnology products are proteins. These proteins are prepared in large volumes, and in purified form. The Food and Drug Administration Sets strict standards for injectable proteins; in fact, most proteins are purified to where they comprise 99.99 percent or more of a sample's material. Proteins must also retain their biological activity (what they do). Only the best methods can make pure proteins consistently.

What's more, methods that work in a research lab might not work in a mass production environment in a manufacturing facility. That's where the BSF’s new capabilities will come in--producing proteins and helping companies figure out how to manufacture them at a large scale.

"From the private sector side, to me, this couldn’t be a better example of how public/private partnerships can make things go," said Linsert. "May many companies be blessed with the advantages this facility gave us 10-12 years ago, and may the people in the world that take advantage of the new pharmaceuticals and the new nutritional products that come from here, be blessed, because they're going to be making a better world."

The Bioprocess Scale-Up Facility is part of the integrated Biotechnology Program (www.biotech.umd.edu) at the University of Maryland's Maryland Technology Enterprise Institute, also called MTECH. The Biotechnology Program includes bioprocessing, manufacturing consulting, and workforce training—all for the purpose of bolstering the State of Maryland's biotechnology industry. MTECH is an institute in the A. James Clark School of Engineering.

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