BioWorld International Correspondent

LONDON - Cambridge Biostability Ltd. (CBL) was awarded a £950,000 (US$1.75 million) UK government grant to apply its glass-stabilizing technology to develop a pentavalent vaccine in a temperature-stable liquid form for use in developing countries.

The company has a commercial development agreement with Panacea Biotec, of New Delhi, India, to produce stabilized versions of Panacea's existing vaccines against diphtheria, tetanus, whooping cough, hepatitis B and meningitis, which will form the basis of the pentavalent vaccine. Panacea will be responsible for clinical trials and manufacturing, with CBL receiving royalties.

Iain Cubitt, CEO, told BioWorld International: "The [UK] Department of International Development gave the £950,000 to help us do the development for Panacea. Once they are satisfied with the stabilized format, we will transfer the technology to Panacea. The money will help to get the show on the road."

CBL's technology produces vaccines that are stable at up to 55 degrees centigrade, removing the need for refrigeration, eliminating vaccine wastage and ensuring potency is maintained. While freeze-dried formulations of some vaccines are available that can be stored at ambient temperatures, they must be reconstituted before injection, thus introducing a risk of contamination. CBL intends to package its vaccines in ready-to-use disposable injectors that can be administered by non-medical staff with minimal training.

Cubitt said it would be possible to combine a number of vaccines stabilized with CBL's technology, and that it would not be necessary to conduct full-scale clinical trials, as all the individual vaccines are approved. "Our advice is the trial will be more limited than if it was a new vaccine, as opposed to a reformulation," he said.

The CBL process is based on anhydrobiosis, a natural process wherein some organisms can go into suspended animation and exist in a dried-up form for many years, becoming active again in the presence of water. The water within cells is replaced with a sugar that solidifies as a glass.

A vaccine is first spray-dried using such a sugar, and the dried vaccine then is suspended in a perfluorcarbon, non-aqueous biocompatible fluid to produce a ready-to-inject formulation. Bodily fluids reactivate the vaccine after injection.

CBL is related to Quadrant Healthcare plc, which listed on the London Stock Exchange, but failed to bring stabilized vaccines to market. Both companies were founded by Bruce Roser, an expert in anhydrobiosis, who, after falling out with the management of Quadrant, found ways to work around Quadrant's 20 patent families.

"He discovered three new ways of forming stabilized glasses that are all quite separate," Cubitt said. "[CBL's] technology is based on the same principles [as Quadrant's], but there is no shared IP."

Since CBL was spun out by Roser a year ago, it has been financed through a number of charitable grants and project funding from the World Health Organization and the Program for Appropriate Technology in Health (PATH), a charity based in Seattle.

In addition, CBL has raised some equity funding from business angels, and is embarking on another private funding round, though Cubitt declined to say how much he hoped to raise.

In partnership with PATH, CBL is developing a range of stable liquid vaccines that will be available at favorable royalty rates in developing countries. Manufacturing will be done mainly in India. Included is the measles vaccine, which despite being based on a living vaccine is stable at 37 C after drying with CBL's process.

Cubitt said CBL is talking to some Western vaccines companies about applying the technology to their products, but he expects the first commercial application to be in stabilizing components of diagnostics, such as antibodies or RNA. The technology can be used also to stabilize any pharmaceutical protein that needs refrigeration.