Advanced contamination-control issues meet Sacramento’s biotech boom

07/01/2005

BY CAROLYN MATHAS

SACRAMENTO, Calif.-What was once simply known as California’s state capital, where most employees worked for the government, Sacramento today is home to academic research and myriad public companies that increasingly implement cleanroom technology.

Although it will take some time to compete with the size of Silicon Valley’s technology base just 100 miles to the west, according to the Sacramento Area Regional Technology Alliance (SARTA), the region’s technology industry grew more than 30 percent in 2004. Today, more than 100 life science and medical device companies, and 15,000 life science employees, call the Sacramento Region-El Dorado, Placer, Sacramento, Sutter, Yolo, Yuba, and Solano Counties-home.

Given that several large companies, including Intel, NEC, Hewlett Packard, and Agilent, have settled in the region, traditional manufacturing and research cleanrooms abound. There are, however, a few noteworthy applications that may indicate how cleanroom technology is evolving and being applied.

For example, Lipomics Technologies (www.lipomics.com) develops tools for drug discovery and personalized medicine using proprietary technologies for lipid metabolite analysis and data interpretation. According to Ryan Davis, laboratory manager at Lipomics, “We measure lipid metabolites, which are fats, for a variety of clients in the pharmaceutical, nutrition and academic industries, to help them understand whether the treatment is diet or drugs, and how the metabolism is changed by a certain stimulus. We analyze plasma serum or tissue samples, the liver, and muscle of humans and animals, working with 14 of the top 15 pharmaceutical companies.”

The Lipomics facility is a Bio-Safety Level 3 work environment. Contamination potential is high, on human hands and in the environment. “We have to be very careful of contamination; we measure very small differences in metabolism,” says Davis. “Our deliverable is numbers and knowledge-analysis of how their drug affects lipid metabolites. We quantitatively measure how much material there is and that generates a concentration of nanomoles of fatty acid per gram of sample for up to 400 metabolite measurements. We filter through them and find which measurements have importance and uniqueness based on how the drug affects the sample.”

During the past two years, Lipomics has continued to develop its cleanroom based on the needs of its pharmaceutical, food and health-industry clients. Since Lipomics interacts with pharmaceutical companies that take its data to the Food and Drug Administration (FDA; www.fda.gov), the company expects to further enhance its operations to be able to fully meet the FDA’s scrutiny.

University-level bio-safety

Another example of an unusual contamination-control facility is under construction at the UC Davis Medical Center here. According to Marsha Koopman, nurse epidemiologist and professor of infectious diseases at UC Davis Medical School, “We had applied for a Bio-Safety Level 4 grant for a research facility laboratory on the UC Davis campus. One of the requirements for the grant was that there must be a biocontainment unit where, if there was an exposure to a virus or bacteria, you could treat the infected worker or researcher. That was the reason for developing the unit. Although we didn’t get approval for the grant, we decided to keep the containment unit in our plans.”

To contain contamination, the ten-bed unit will have its own ventilation system, separate collection tank for sewage, emergency, and operating rooms, and its own laboratory space. Called the Pavilion, the facility is the first of its kind in the country. The project is in the design phase and has been submitted to the Office of Statewide Planning and Department for approval. It is expected to be on-line in approximately three years.

At the UC Davis Cancer Center, molecular biologist Philip Mack, PhD, studies live cancer cells under the protection of laminar-flow hoods. Recently, findings of a Phase II Southwest Oncology Group Study SWOG-9504 indicated that of patients treated with the regimen under study, 29 percent were alive after five years versus 17 percent of patients from a previous study. According to David Gandara, professor of medicine and director of clinical research at the Center, “The SWOG-9504 regimen can now be considered a standard of care for patients with unrespectable, stage-three, non-small cell lung cancer.”

Expectations are that other biotech growth will continue in the region, given its low cost of living, combined with a recruitment base of highly-qualified employees, and first-class university and medical operations. Among future possibilities, the Sacramento region recently made the “short-list” to be considered for the headquarters of the California Institute for Regenerative Medicine (CIRM; www.cirm.ca.gov). CIRM was established this year following the passage of Proposition 17-the California Stem Cell Research and Cures Initiative. The statewide ballot measure provides $3 billion in funding for stem cell research at California universities and research institutions. III