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Little firm, big responsibility

Little firm, big responsibility

Wako Chemicals USA makes a drug used to test purity of medicine. Andy Liffert, left, and Yashihire Takasuga set up the mixture to begin bottling.


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The somewhat arcane but vital business of keeping you alive is thriving in Chesterfield County.


In a nondescript building off an industrial stretch of Bellwood Road between Interstate 95 and the James River, a Japanese chemical company is busy producing a fine, white powder used to test the safety of injectable medications and artificial joints.


Because a trace of bacteria can turn a life-saving injection into a lethal concoction, the work done at the Wako Chemicals USA Inc. facility -- and at three other companies on the East Coast -- is a vital step in a process that ensures the safety of prescription drugs and replacement parts for people the world over.


The process has been going on in Chesterfield for about two years, when Wako (pronounced "waah-ko") opened the processing facility after acquiring a St. Louis-based company that made the test.


"We don't make medicine, but we make the test that makes sure it's safe," said Ronald N. Berzofsky, the general manager of Wako's division that makes the solution. "We're very, very proud of what we do here. Just not a lot of people know it."


From the outside looking in, there's no reason to know it.


The production takes place in one of 16 buildings on Wako's campus. The buildings differ in size and purpose -- the company also makes chemicals used in a variety of laboratory tests -- but are otherwise fairly indistinguishable.


Inside, though, the serious business of safety takes shape as the blue, copper-rich blood of horseshoe crabs settles, separates and is freeze-dried. The powder is extracted after the freezing.


In a three-day process, the blood becomes limulus amebocyte lysate, or LAL. Drugmakers use that substance to test batches of their medicines. If the mixture of LAL and the drug congeals, the batch is contaminated. If it remains liquid, it's good.


Each batch of medicine is tested at least three times, with samples from the beginning, middle and end of production runs.


For replacement joints, the LAL powder is used to create a solution in which the parts that are tested can be soaked. If the solution comes out clean, the parts are sterile and that batch can be shipped to market.


Wako makes the substance in batches of 3,000 50-test vials or 12,000 single-test vials. About 100 test units can be made from the blood of a single horseshoe crab.


The purity of Wako's LAL is determined by the Food and Drug Administration, which tests samples it is sent.


The company declined to release annual production figures. The tests each cost $1.50 or less, depending on the quantity purchased.


The LAL process doesn't have a huge economic impact -- Wako has a modest share of the $50 million market, said L. Todd Lumadue, a procurement and product manager at the company. But that doesn't lessen its importance locally.


"We really value small companies," said Will Davis, the director of Chesterfield economic development. "They're the backbone of what we do."


Wako, he said, is one of 41 companies with international roots in the county.


And the company's story is compelling, too, he said.


"It's one of those things people don't even know exists," he said. "It really is a global market."
Contact Zachary Reid at (804) 775-8179 or zreid@timesdispatch.com.

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