Manufacture of low cost, high efficacy vaccines

There is a major need for preventative healthcare to reduce the growing load on the budgets required for medical treatment of conditions such as hepatitis, cervical cancer and seasonal and pandemic flu. Vaccines provide such a means to address this increasing challenge to society. However there is a need for new candidates which offer the potential for improved protection at lower cost and to greater numbers of the community. Such new candidates must not only exhibit medical effectives and safety but also must be suitable for manufacture at the industrial scale. The new candidates described in this proposal offer the potential to construct new molecules, so-called fusions, which can both use the benefit of the body's immune system to deliver directly to the sites in the body the agent to elicit the protective (immune) response. The technology to be developed in this programme will also provide the early test bed of the manufacturability of these new candidates when only small amounts of precious material are available. In this way a range of candidates may be testesd and, if neccesary new types of fusions to be designed which not only offer high levels of protection but are more readily manufactured, stored, and supplied to the patient. The research sequence will be to agree specifications of validatable large-scale bioprocesses for fusion protein production and purification. These processes will be characterised to quantify the regions of high stress which may result in damage to the fusion proteins. Ultra scale-down devices will be used to mimic these high stress regions and used to test small qualities of fusion proteins and their response to stress. These results will be used to predict the large-scale operation and these predicitions verified in collaboration with a programme partner, Cobra. This verified platform will be used to examine new fusion protein constructs and help in selection and choice of candidates for large-scale development.