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Cell BioSciences Places Prototype Protein-Analysis Instrument at Stanford in Anticipation of Launch

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Following a total revamp in its management, Cell BioSciences last week announced that it had placed its first next-generation protein analysis system at Stanford University School of Medicine in anticipation of its launch.

The new instrument, a CB1000 prototype, was placed in the laboratory of David Hirschberg, director of the Human Immune Monitoring Center at the university, who will use it to analyze oncoprotein activation. He will also help Cell BioSciences optimize the instrument.

The CB1000 is the second instrument that Cell BioSciences has developed but would represent the company's first full platform launch. Anticipated to become available in the middle of the year, the CB1000 would replace the company's Firefly 3000 system, introduced in April 2006.

As the firm moves into full commercialization mode for its platform and related products, it also has undergone sweeping management changes, replacing, among others, its president and CEO, posts now held by Tim Harkness, the former CFO of Molecular Devices.

Cell BioSciences was founded about five years ago with a technology focus on cellular assays and capillaries. But in the process of doing that work, the company "invented a technology here that allows us to immobilize proteins on the inner wall of the capillaries," Wally Ausserer, the newly appointed vice president of marketing, told ProteoMonitor last week.

"And that really allowed us to take off,” he said. “Where we felt capillary-based technologies had really taken off for genomics and other types of analyses, we felt they really hadn't for looking at proteins."

Cell BioSciences' core technology is an immunoassay that is performed in six steps, according to the company's web site. The first step calls for a capillary to be filled with a sample mixed with separation buffer and standards. Proteins are then separated by isoelectric points based on isoelectric focusing.

"Why that is important is that it will allow us to eventually look at the different phosphorylation states of a protein," Ausserer said.

The capillary is then exposed to UV light, which activates cross-linking chemistries and immobilizes the proteins. Specific proteins are probed with primary antibody and HRP-labeled secondary antibodies. Detection reagents are flowed into the capillary, producing chemiluminescent light, and finally the emitted light is captured with a CCD camera, digitized, and quantified.

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One of the advantages of Cell Biosciences' technology, according to Ausserer, is that it uses very small sample volumes — the Firefly and CB1000 can perform an analysis with a sample containing as little as 25 cells. By comparison, Western blots need tens of thousands of cells and mass specs require about 100,000 cells.

"The total assay volume inside the capillary is 400 nanoliters," he said. "We're doing protein analysis on an extremely small scale."

The benefit of this is that in many cases, for example with isolated stem cells, researchers may be working with small sample sizes to begin with.

"There is a whole range of samples that are extremely limited that people have never been able to do protein measurements on," Ausserer said. "Our big benefit is being able to separate out the different phosphorylation states of proteins on these small samples.

"So if you're looking … for example [at] the actions of a kinase inhibitor used therapeutically … and you have extremely small patient samples and you want to understand where the drug is being effective or not, or what pathway it's hitting, they're very difficult measurements without a way of looking at the different phosphorylation states,” he said. “And that's what we provide."

The Cell BioSciences platform is especially useful when a protein has multiple phosphorylation states and the sample size is limited, he added.

Because the Firefly and CB1000 are antibody-based technologies, they depend to a degree on the quality of antibodies that a researcher uses. But, unlike with antibody arrays, where antibody quality has been a significant obstacle to the maturation and adoption of the technology, the Cell BioSciences’ platform calls for a separation step, which mitigates the requirements for antibodies, Ausserer said, and so the technology is "a little more forgiving than a dot-blot or array would be."

While Cell BioSciences has focused on phosphorylation because that's where most scientific interest is in, the technology should work with other types of post-translational modifications in theory, Ausserer said.

Pharma Now on Radar

Hirschberg did not respond to a request for an interview, but according to Ausserer, he will be running samples of the proteins ERK and MEK on the CB1000 to compare its performance with the Firefly. Improvements to the CB1000 include higher sample throughput and greater ease-of-use. The CB1000 will have 384-well plates compared to 96-well plates on the Firefly, and software has been "completely rewritten" to "make data analysis much easier," on the new system, Ausserer said.

The CB1000 will also be a benchtop system whereas the Firefly is a floor-standing platform.

Ausserer said a price for the CB1000 had not yet been decided but the Firefly typically sold for $400,000.

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He also would say only that fewer than 10 Firefly systems have been placed, primarily at medical schools and medical research centers. In addition to Stanford, Lawrence Berkeley National Laboratory has a Firefly.

The system, according to Ausserer, was never designed for widespread commercialization; instead, the idea was to develop a technology platform that would serve as a jumping-off point for further development.

"Our goal was to really get the technology mature enough to enable the next generation," he said. Once the CB1000 is ready for market launch, the Firefly will be mothballed, though Cell BioSciences will continue to offer customer support for the platform. Unlike the Firefly, the CB1000 will also be targeted to pharma and biotech customers as well as academic researchers.

In November, the firm launched its first assay kit for the Firefly, which will be optimized for use on the CB1000.

In addition to Harkness, who replaced Linda Cahill as CEO and president, and Ausserer, Cell BioSciences' hired a new vice president of sales and international operations; CFO; vice president of engineering; and vice president of R&D during the summer [See PM 06/26/08 and 07/03/08].

The changes in management, Ausserer said, were made to help the company as it transitions from a technology start-up to a full commercialization organization, and each of the new hires has "built strong fully integrated commercial companies."

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