Medical Device Daily

DENVER – Ira Flatow seemed a bit out of sorts. Grumpy, actually.

In his luncheon presentation during the first day of BioWest 2006, held last week at the Colorado Convention Center, the well-known science correspondent for National Public Ra-dio issued a variety of acerbic complaints about how difficult it is to get significant science news into the mainstream national media – first, because of America's fading interest in science but mostly because the major newspaper and TV pipelines are more focused on selling advertising than reporting what really counts as news, he says.

Seeming to undercut Flatow's complaint, however, news of a $6 million gift to the University of Colorado (CU; Boulder) for stem cell research shoved the John Mark Karr/JonBenet headlines to the bottom of the front pages of Colorado's main dailies. And other headlines about new progress in stem cell developments did the same in most national newspapers.

The university is receiving the multimillion-dollar gift from Denver's Gates family, built on the success of Gates Rubber , Colorado's biggest global firm.

The largest research gift ever received by UC's School of Medicine, the money will be used to establish the Charles C. Gates Regenerative Medicine and Stem Cell Biology Program. The program will be led by Dr. Dennis Roop, currently professor and director of the Center for Cutaneous Molecular Biology at Baylor College of Medicine (Houston) but relocating to CU in January and bringing with him dozens of researchers in an effort to establish a large new footprint for the university – and for Colorado – in this field.

“We will be a national leader” in stem cell research, Chancellor M. Roy Wilson said in announcing the gift. “We are not now, but we will be. That's our goal.”

Of course these big-headline exceptions only prove the rule.

Stem cell news (and any big money attached to it) rides like a suckerfish on the back of controversy about the Bush administration's cap on federal funding of stem cell R&D and the broader criticism that political and cultural forces in Washington are interfering with scientific progress.

Meanwhile, significant science stories do go largely unnoticed.

“We can't get the local media to come out and write about what we do here,” said Anne Bonelli, communications specialist for Gambro U.S. Businesses , during our media tour of two buildings of the company's five-building campus in nearby Lakewood.

The reason is obvious.

Attempting to describe the technicalities of acquiring donated blood, separating it into important therapeutic parts and finding new ways to make sure that it is absolutely safe are needs that have been around for a long time and don't set off a spontaneous “wave” in mainstream editorial meetings.

Then too, most of the news about Gambro doesn't point to blood safety. The name usually relates to renal dialysis. And blood component technology – the BCT of this Gambro unit – is listed as second in the parent company's annual report.

Most generally, Gambro BCT is in the blood-processing business. Interestingly, its seed technology was developed by researchers at IBM , the unit then spun off to Cobe , when seen as non-core, and then purchased by Gambro.

The first building we visit is immaculate, dominantly white, with teams of white-robed and white-masked technicians working behind glass, an emphatic underlining of the need for cleanliness and component separation.

At one point we have to step aside in the corridors to make way for small automated carts – humorously dubbed “Natasha” and “Boris” – that ramble on a snaky subway rail in the floor, delivering parts, an indication of the reach for greater automation throughout the building

In one room we get a close look at two of the company's major product lines being tested. For each batch, nothing can go out of the building until a random sampling is tested, according to a technician. She tells Medical Device Daily that she has found only one fault for the year, describing it only as a “black blip” in a computer program running one of the systems.

Gambro BCT's flagship product is Trima, an automated system for collecting blood from donors and separating it into its primary components. Trima Accel is the newest version of the machine, with the company currently focused on converting its Trima blood bank customers to Accel.

The company prides itself on an FDA clearance last year for a system providing seven-day storage of single donor platelets, platelets normally restricted to five-day storage. The clearance covers platelets collected by Trima and also the company's COBE Spectra systems, when tested for bacteria. The seven-day storage of course extends the viability of the platelets in a highly time-sensitive medical sector.

The other machine being tested in the room is the Spectra system. The Spectra instruments take blood and separate it in different ways for therapeutic applications. And the company banners the COBE Spectra Apheresis system as “the world's most used system for therapeutic apheresis and adult stem cell therapy.” Elutra, a technology for processing cells for a variety of biological sources, was launched in 2004

But clearly the most innovative effort is found in the second building on our tour, entirely dedicated to R&D for the company's Mirasol pathogen reduction technology, not yet cleared.

A lead Gambro BCT chemist – who declined being named or directly quoted, the product of a characteristic humility rather than need for secrecy, Bonelli tells us – describes earlier efforts to develop synthetic methods for killing pathogens in blood. The problem here, though, is that synthetic materials themselves might result in complications for patients already immuno-suppressed.

Hence the search shifted to finding natural materials and methods for pathogen-killing. The result of that search: simple riboflavin.

The process is simple. A mixture of riboflavin is added to the particular blood component of interest in a bag and the bag is then inserted into a machine looking very much like a tabletop copier. The machine then illuminates the bag with visible fluorescent light in a method “exciting” the reaction of the riboflavin and inactivates the pathogens.

The company has initiated Mirasol trials for inactivating pathogens in platelets and will commence trials in plasma “next year,” we are told, and subsequently for red cells.

Timelines for the necessary FDA clearances and approvals aren't given – “lots of variables,” we are told.

The whole effort was first described as requiring $50,000 and six months, the humble chemist says. But, thus far, it has turned into several years and “many millions.”

It's a great effort out of Colorado's biotech community – but when finally FDA-okayed, likely to produce headlines only in trade publications such as MDD.

Next: Corralling electricity.