The purification and production of toxins from emergent Clostridium difficile hypervirulent strains for use in Vaccine Research

Clostridium difficile infection (CDI) is a major cause of morbidity and mortality in
economically developed countries. CDI is primarily linked with hospital admission and prior
antimicrobial treatment. Although significant advances have been made to reduce incidence, a number of hypervirulent and highly transmissible strains have recently emerged. Resultant healthcare challenges are compounded as widespread use of antibiotics encourages both the emergence of resistant strains and reoccurrence of infection, especially in the elderly.
The financial impact of hypervirulent strains on the healthcare system is substantial ($1.1
billion/year in the USA). Assuming a European Union population of 457 million, the potential cost is estimated to be €3000 million/year, and without targeted treatment is expected to double over the next four decades.
In response, pharma focus is shifting toward the development of vaccines for single “catchall” immunisation. However, due to inability to source highly pure native (representative of the true functionality) toxins, vaccine researchers cannot fully determine how antibodies may be cross-protective and whether there is cross reactivity between strains.
NAC will aim to use its current expertise in native antigens to isolate and purity the native
toxin strains for the first time and at a yield which meets demand. There are no known
commercial suppliers of such toxins.
We are a newly formed biotech company (November 2010) that specialises in the
manufacture of high value infectious disease antigens for the vaccine and diagnostic Industry.
NAC now trades with over 30 companies worldwide with exports representing over 85% of
its business.
NAC has an agreement with a pharmaceutical company to support this proof of concept by
evaluating project development progress. This company will become an adopter to provide
early revenue. There are no market restrictions placed upon NAC to prevent it selling to the
open market.