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Passing The Tests

It’s a good sign when a company has to move into a larger space.

Calbiotech Inc., which manufactures life science products, outgrew 11,000 square feet in Spring Valley and recently traded up to 22,000 square feet in El Cajon. It also recently hired six employees, giving it a headcount of 45.

Calbiotech makes immunoassays, or biochemical tests. A sister company, Moduline Systems Inc., manufactures what looks more like assembly-line equipment with conveyor belts, but it’s still related to biochemical tests. Moduline’s customers in the research space and the in-vitro diagnostic industry use the equipment to fill microplates and vials — or to wash the same.

The business is just one example of a much larger medical device cluster in San Diego County.

Joseph Alosachine works in the lab at Calbiotech. The company makes immunoassays and related items. Calbiotech ships to 70 countries with half its revenue coming from exports.
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Calbiotech made it a point to notify customers well in advance of its move from Spring Valley, and had 10 days when it couldn’t ship product. It hosted inspectors for three days, assuring compliance with Food and Drug Administration and ISO 13485 standards. The latter standard is for manufacturing medical devices.

“It’s like starting from scratch again,” said Noori Barka, the firm’s top executive and sole owner.

The business is running again, but there is still much to do to finish the move.

East County Cluster?

This could be the beginning of an East County biotech cluster, Barka said. He is a trained scientist — Barka has a doctorate in diagnostic immunology — but there is some rose-colored salesmanship in his assertion, on top of the cool logic.

He points to the view outside his office: the runway of Gillespie Field is flanked by rolling hills to the north and east. The rent here is a lot cheaper than Sorrento Valley, he said.

Barka declined to give Calbiotech’s revenue. “We consider ourselves a small business,” he said.

Mark Liuag

There are several factors behind the company’s growth, including the shipment of more kits as well as growth in international and university markets, said Mark Liuag, the company’s director of operations.

Half of the company’s revenue is from exports and Calbiotech ships to 70 countries. Eight hundred universities use its products. Its immunoassays are cited in more than 1,000 scientific papers.

Calbiotech began in 1998 with three people sharing 800 square feet of space. It was Barka; his wife, Evelyn Barka; and one technician.

“I’m a scientist,” Barka said. “I had to become a businessman. That was a challenge: how to market, how to get a product out.”

A Zika Test

The first few years of operation were a bit of a struggle, he recalled. Calbiotech’s first product line tested thyroid and fertility.

The line is much bigger now, with upward of 150 tests.

Calbiotech is now at work preparing a test for Zika, a mosquito-borne and sexually transmitted disease that has been linked to underdeveloped heads (microcephaly) in fetuses. The outbreak has mostly affected Central and South America. The World Health Organization has called the Zika outbreak a public health emergency.

One selling point for Calbiotech tests is that their chemistry has a longer shelf-life than that of competitors, Barka said.

Technological Shift

The business is moving from a technology that uses a plate with multiple wells for samples (a common size plate holds 96 wells) to a more automated technology that uses magnetic beads. Such beads measure 1 micron across — much smaller than the eye can see, about the size of certain bacteria and seven times smaller than a human red blood cell. The beads are coated with layers of biomaterial.

Calbiotech marketing materials call the beads “a great starting point for a wide range of assay development.”

The business is pursuing a patent on one particular aspect of its bead technology.

An Italy-based medical device maker, Diagnostic Bioprobes SRL, is a potential partner in using the bead technology.

One of the newest additions to the Calbiotech lab is a $700,000 machine from Diagnostic Bioprobes. The machine, called SARA, evaluates chemiluminescent immunoassays, or CLIA.

The Italian company’s device and Calbiotech’s products come together to form a complete test. Barka said his business is developing a “menu” of tests for such a machine.

The SARA machine can run 120 tests per hour, can conduct 15 different tests simultaneously, and offers more flexibility than competing technologies. It is also relatively small — about the size of a compact washer-dryer unit for an apartment.

Similar, older machines cost in the tens of millions of dollars, which meant that only large businesses could have them. Machines like the SARA “lets small guys like us play in the market,” said Liuag.

The business has a similar Chinese machine on order, which does not have as high a price tag as the Italian-made SARA.

Another selling point for magnetic bead technology is that it is fast: about five times faster than traditional plate technology, Barka said.

As they move into a new way of doing things and keep the business running, Calbiotech employees have to finish setting up their new office and lab space.

So far, the move looks like it’s been worth it. Laboratory spaces, offices and conference rooms are twice the size as they were in Spring Valley.

“We hope to have enough room to grow in this facility,” Barka said.

CALBIOTECH

President: Noori Barka

Revenue: Undisclosed

No. of local employees: 45

Investors: Noori Barka is the sole investor

Headquarters: El Cajon

Year founded: 1998

Company description: Maker of immunoassays and related items

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