Emerging Drug Developer: Stabilitech

Stabilitech sets out to break the cold chain

One of the biggest problems associated with vaccines has to do with transporting them from the manufacturing site to wherever they're needed. And they're needed virtually everywhere on the planet.

Most vaccines typically have to remain refrigerated, no easy task if you're packaging up your products for delivery to, say, Malawi or the outer islands of Indonesia.

But London-based Stabilitech believes its technology can break the cold chain.

The essential clues for its technology came from nature, explains Stabilitech CEO Barbara Domayne-Hayman, pointing to a project that germinated two thousand-year-old palm tree seeds. "Nature solved the problems of storing complex molecules in adverse conditions," she says. A class of proteins played a key role in the seeds' stabilization, and the company has mimicked that process with a protein chemical system of its own.

That system has already been used to stabilize live virus vaccines, says the CEO, which was the company's initial target. But it can also be used to stabilize other vaccines as well as biopharmaceuticals--which has the potential to greatly expand the use of the technology.

"Adenovirus vaccines have to be stored at minus 80 degrees centigrade," says Domayne-Hayman. "We can store live adenovirus at 37 degrees (centigrade) for three months. It also works for measles, which is a very, very fragile, sensitive virus. We used it as a model system to show what the stabilization technology can do.

"The goal is to be able to keep vaccines at ambient temperatures," she adds. "We are currently exploring the applications to flu. Our technology is potentially applicable to all forms of influenza vaccines. It's also very useful for stockpiling vaccines."

Over the past few years the vaccine industry has undergone some dramatic changes as big manufacturers jumped back into the business after being driven out by thin margins and fluctuating demand. This year the big manufacturers are seeing a multibillion-dollar windfall from the swine flu pandemic. But the pandemic has also underscored the need for providing more jabs to underdeveloped countries for a much lower cost than more affluent countries can bear. Stabilitech hopes to help manufacturers achieve that goal.

"It's all very, very inexpensive, a very simple and very robust process" that relies on standard freeze-drying technology that the major manufacturers already have in place, says the CEO.

"It's still in the experimental stage," she adds. "We are starting to sign feasibility studies with manufacturers now to take the technology forward. There are a couple of feasibility studies ongoing right now. But we're very much a platform technology company. We're not planning at this stage to have our own clinical pipeline. We're licensing the technology to the major companies to take it forward--a straight licensing model. We hope to sign our first licensing deals in 2010."

That's an ambitious goal for a company that's still very much in start-up mode. While the company was registered in 2002, it only got around to hiring its first scientist in 2007. Domayne-Hayman, a chemist, joined the company in late '07 after she had completed a stint as commercial director at Arrow Therapeutics, which was bought out by AstraZeneca. Last March, the company gained 3.3 million pounds sterling in a financing round provided by high net worth individuals, giving Stabilitech enough funds to bump its ranks to 10. And the company plans to hire a few more scientists in the next couple of years--"to cope with the additional feasibility studies we'll be doing."

While vaccines are Stabilitech's first priority, the company also sees tremendous promise in providing the same kind of stabilizing technology to the companies which make many of the world's biotech drugs.

"It's also very reliable for stabilizing antibodies, enzymes, proteins like growth factors," says Domayne-Hayman. "There are a lot of vaccines for animal health and lots of interest from animal health companies."

Emerging Drug Developer: Stabilitech
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