BioWorld International Correspondent
LONDON - Up to 90 percent of immunization budgets are spent on the logistics of maintaining the cold chain, and even so, around 50 percent of vaccines are spoiled. Now a UK start-up, Stabilitech Ltd., has a new technology for stabilizing vaccines in a powdered form at ambient temperatures, using excipients that are approved for use in drug manufacture.
Although a number of other methods for stabilizing vaccines are in development, the company claims it is the first to be able to stabilize live viruses, opening the way for the development of new vaccines where the virus is difficult to stabilize, including measles, flu, and yellow and dengue fever.
"There are lots of technologies out there attempting to stabilize vaccines, but no one has brought anything to market," said Barbara Domayne-Hayman, newly appointed CEO of Stabilitech.
"It's in the nature of these things that there are lots of attempts and failures before someone makes a breakthrough. We think we are in a position to do that," she said.
The dried vaccines will not need to be rehydrated for administration, avoiding the need for injections. According to the company, the technology is at least 50 times more effective than any other method of stabilizing live viruses, and the results are indistinguishable from refrigeration.
The technology development is at an early stage, and although it is attracting attention from vaccines manufacturers and health charities, there are no formal partnerships in place. "We are now optimizing on all fronts with the aim of having a process which is extremely easy to use, as an extra step that fits with existing manufacturing processes," Domayne-Hayman said.
The company is taking advice currently on what the likely regulatory pathway will be for products stabilized with its process, which will have broad applicability beyond vaccines to all protein drugs. It is intending to commercialize through license agreements with a range of companies for different vaccines and drug types.
To date Stabilitech has been funded by private business angels. Domayne-Hayman, who joined from Arrow Therapeutics plc, the antivirals specialist acquired in February by AstraZeneca plc, said, "We are well funded at present as we take the science forward." The company has just relocated from the government Institute for Animal Health in Pirbright, Surrey, (where it was caught up in the accidental leak of foot and mouth virus that led to a recent outbreak of the disease), to the incubator at Imperial College, London.
Stabilitech has not disclosed any details of the stabilization technology, other than to say it is based on research by scientific founder Jeff Drew into how seeds remain stable at ambient temperatures.
Also this week, the doors were revolving at another UK specialist in vaccines stabilization, Cambridge Biostability Ltd. The company announced the appointment of Luca Guerzoni as CEO to succeed David Stone beginning Jan. 1. Stone will become a nonexecutive director. Guerzoni is a veteran of two vaccines manufacturers, Chiron Corp. and Sanofi Pasteur.