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Serologicals Units and Cellumen to Develop, Sell Cytotoxicity Profiling Panel, Services, to Pharma


Two divisions of Serologicals and Pittsburgh-based biotech Cellumen plan to co-develop and sell a cytotoxicity profiling panel and services for use in pharmaceutical drug discovery, the firms said this week.

For reagent provider Serologicals, the partnership marks the biggest step it has taken to date in the direction of cell-based assays for drug discovery; specifically, it expects the deal to help it gain a foothold in the high-content cellular-assay market, an area in which it has limited experience.

Meanwhile, the deal marks Cellumen's first co-development and co-marketing alliance and may provide the nascent company with much-needed marketing muscle for its "systems cell biology"-based drug-discovery service model.

Under the terms of the agreement, Serologicals will provide reagent expertise and products, primarily through its Chemicon subsidiary, but also through its Upstate division. Chemicon-Upstate will then work with Cellumen to develop a panel of assays designed to better profile the cytotoxicity of candidate compounds at pharmaceutical companies.

The two companies will then co-market the assay panel, with Serologicals focusing on providing products for customers to use in-house, and Cellumen incorporating the assays into its drug-discovery services.

"Up to now, the Holy Grail of cytotoxicity has been to make a predictive tool — at least, predictive of human response — and that hasn't occurred."

According to Cellumen president, CEO, and co-founder Lansing Taylor, the panel of assays will measure "more than three or four, and less than an infinite number of parameters" as part of what he calls a systems cell biology approach to profiling cellular drug toxicity.

"Up to now, the Holy Grail of cytotoxicity has been to make a predictive tool — at least, predictive of human response — and that hasn't occurred," Taylor told CBA News. "From our perspective, it hasn't occurred because the right assays have not been performed — they've been rather simple, and it's not a surprise that it's not predictive.

"Clearly the pharmaceutical industry needs to fail compounds earlier, and even before such a tool would be predictive, there could be a big impact if you had a … very powerful panel [of assays] to prioritize compounds," Taylor added. "To be valuable, it doesn't have to be predictive, and that's our ultimate goal."

Dennis Harris, vice president of R&D and business development, and CSO of Serologicals, told CBA News that the two companies would initially develop a panel of about a dozen assays that would address different cellular pathways.

As part of this development process, Chemicon-Upstate will "identify reagents that we have, whether they're antibodies or other types of reagents, and then supply them to Cellumen for initial testing," Harris said. "Essentially together we'll then try to develop a panel that is useful in the short term for prioritizing compounds in the drug-development process. Longer term, we'll hopefully be able to come up with assays or panels of assays that are actually predictive of human toxicology."

The alliance is the biggest step Serologicals has taken to date in the direction of cell-based assays for drug discovery. Between its Chemicon and Upstate subsidiaries, Serologicals boasts a catalog of approximately 11,000 products, according to Harris, including antibodies, proteins, and various biochemical and cell-based assays. Its biggest cell-based assay play to date has been a series of reagents for cell-based GPCR assays, which the company has developed and marketed over the last year.

"We have a business based out of Dundee, Scotland, where we do kinase selectivity screening," Harris said. "That's not a cell-based assay — it's [a] biochemical [assay] — but it's certainly brought to our attention the desire in the pharmaceutical industry to understand toxicity in the context of the cell.

"So this agreement with [Cellumen] is a first step for us in really trying to understand that marketplace and what's required," he added. "We clearly see the industry moving toward these more complex cell-based assays, and we think we'd like to build our reagent portfolio in helping them to do that."

"We clearly see the industry moving toward these more complex cell-based assays, and we think we'd like to build our reagent portfolio in helping [it] to do that."

The deal also marks Serologicals' first foray into the high-content screening and analysis space. Cellumen's Taylor was one of the co-founders of Cellomics, and one of the earliest innovators of HCS. He also served on Cellomics' board until it was acquired by Fisher Bioscience earlier this year, and remains a Cellomics customer and a vocal proponent of HCS.

According to Taylor, HCS will "be an important part" of the cytotoxicity assay panel development, "although the way we describe systems cell biology is really an integration of whole-plate and HCS reads," he said. "Depending on the reagent and the parameter being used, it will be a combination, but clearly we believe that HCS is the more powerful of the two."

Serologicals' Harris said that his company doesn't have much direct experience with high-content screening. "We are hoping to learn from Lance and his team more about the kinds of instrumentation and software that are out there and being able to apply that to developing appropriate reagents and applications for those technologies," he said.

For Cellumen, the agreement also plays into Taylor's previously stated strategy of minimizing dependence on VC cash, and instead building business early through industry partnerships and some reagent sales.

"I'm building Cellumen in a very different way than a traditional 1990s company," Taylor reiterated last week. "We are not going to try to do everything ourselves and create a complete solution within one company. You'll be seeing a range of strategic relationships in the future."

Taylor added that Cellumen is designing its own reagents, but stressed that "there are existing reagents — whether they're fluorescent proteins, antibodies, or whatever — that if you choose the right biomarkers, there is no reason to recreate the wheel."

To that end, Cellumen has already licensed a positional biosensor from Cellomics, a random siRNA library from the University of Pittsburgh, and a gene-switching technology from RheoGene.

The Chemicon-Upstate deal marks Cellumen's first co-development and co-marketing alliance, and thus may provide the tiny company with much-needed marketing muscle. According to Harris, Serologicals has a worldwide sales force of approximately 80 people, concentrated mostly in the US and Europe, with two distributors in the rest of the world. Cellumen, which was founded in 2004, currently has only a handful of employees. It is currently attempting to fill several scientific positions, but Taylor so far has been the company's lone marketing representative.

"I think we can provide a good route to market for the assays once we develop them together," Harris said.

— Ben Butkus ([email protected])

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