The Future Vaccine Manufacturing Research Hub (Vax-Hub)

Lead Research Organisation: University College London
Department Name: Biochemical Engineering

Abstract

Vaccines are the most successful public health initiative of the 20th century. They save millions of lives annually, add billions to the global economy and extended life expectancy by an average of 30 years. Even so, the UN estimates that globally 6 million children each year die before their 5th birthday. While vaccines do exist to prevent these deaths, it is limitations in manufacturing capacity, technology, costs and logistics that prevent us for reaching the most vulnerable. The UK is a world leader in vaccine research and has played a significant leadership role in several public health emergencies, most notably the Swine Flu pandemic in 2009 and the recent Ebola outbreak in West Africa. While major investment has been made into early vaccine discovery - this has not been matched in the manufacturing sciences or capacity. Consequently, leading UK scientists are forced to turn overseas to commercialise their products.

Therefore, this investment into The Future Vaccine Manufacturing Hub will enable our vision to make the UK the global centre for vaccine discovery, development and manufacture. We will create a vaccine manufacturing hub that brings together a world-class multidisciplinary team with decades of cumulative experience in all aspects of vaccine design and manufacturing research. This Hub will bring academia, industry and policy makers together to propose radical change in vaccine development and manufacturing technologies, such that the outputs are suitable for Low and Middle Income Countries.
The vaccine manufacturing challenges faced by the industry are to (i) decrease time to market, (ii) guarantee long lasting supply - especially of older, legacy vaccine, (iii) reduce the risk of failure in moving between different vaccine types, scales of manufacture and locations, (iv) mitigating costs and (v) responding to threats and future epidemics or pandemics. This work is further complicated as there is no generic vaccine type or manufacturing approach suitable for all diseases and scenarios. Therefore this manufacturing Hub will research generic tools and technologies that are widely applicable to a range of existing and future vaccines.
The work will focus on two main research themes (A) Tools and Technologies to de-risk scale-up and enable rapid response, and (B) Economic and Operational Tools for uninterrupted, low cost supply of vaccines. The first research theme seeks to create devices that can predict if a vaccine can be scaled-up for commercial manufacture before committing resources for development. It will include funds to study highly efficient purification systems, to drive costs down and use genetic tools to increase vaccine titres. Work in novel thermo-stable formulations will minimise vaccine wastage and ensure that vaccines survive the distribution chain. The second research theme will aim to demystify the economics of vaccine development and distribution and allow the identification of critical cost bottlenecks to drive research priorities. It will also assess the impact of the advances made in the first research theme to ensure that the final cost of the vaccine is suitable for the developing world.

The Hub will be a boon for the UK, as this research into generic tools and technologies will be applicable for medical products intended for the UK and ensure that prices remain accessible for the NHS. It will establish the UK as the international centre for end-to-end vaccine research and manufacture. Additionally, vaccines should be considered a national security priority, as diseases do not respect international boundaries, thus this work into capacity building and rapid response is a significant advantage.

The impact of this Hub will be felt internationally, as the UK reaffirms its leadership in Global Health and works to ensure that the outputs of this Hub reach the most vulnerable, especially children.

Planned Impact

To become an International Centre of Excellence the Hub will interact with multiple stakeholders in the vaccine community and ensures that the benefits of this research are felt far and wide. The immediate beneficiaries of this work will be the organisations who engage with the Hub, including UK industry and academia, Catapults, such as the National Biologics Manufacturing Centre and LMIC vaccine manufacturers. The outputs from this work will also assist other manufacturing Hubs and further the work of the UK Vaccine Network, as many of the research topics tie into strategic policy areas. This work will create new and improved vaccines for LMICs, enable our ability to respond to epidemic scenarios and ultimately boost the UK bio-economy by advancing vaccine manufacturing.

The mechanism of engagement will be through training and online courses, conferences and publications in peer-reviewed journals, feasibility projects that feed projects into the Catapults centres, and Expert Interaction Vouchers. These will be promoted through existing networks such as KTN, academic networks, other Hubs and the Developing Country Vaccine Manufacturing Network (DCVMN).

Training and Online Courses. The Hub members currently run training programmes in bioprocessing, analytics and vaccine development as part of its CPD offering to the vaccine industry and research outputs from the Hub will be included into these training programmes. We will offer funding for 10 places annually for academics and industry from LMICs to attend these courses. To address the national shortage of Qualified Persons (QPs), we will recruit two trainee QPs and provide them with hands-on training in user GMP manufacturing facility, and mentorship to allow them to complete their training and support industry needs. A dedicated Training officer will ensure maximum dissemination of the Hub's work, especially to the DCVMN, by creating online training material that will survive beyond the grant period.
Conferences and Publications. The Hub will hold an all user annual meeting where outputs from the Grand Challenges and Feasibility projects are presented. All partners will be encouraged to publish in Open Access journals. Business Briefings, Special Interest Groups and Industry Open Days, will ensure we continue to increase user engagement over the lifetime of the Hub and create the trained individuals with skills to take the industry forward.
Feasibility Projects will benefit all users that are not currently part of the Hub. Each project can range from a minimum of 6 months to 3 years and receive funding of up to a maximum of £100k p.a. for personnel, PI time and consumables. These grants will explore early technologies and help to generate pilot data for follow on funding. It will link to Catapults, such as the National Biologics Manufacturing Centre, to test feasibility.
Expert Interaction Vouchers will be available for UK and LMIC vaccine manufacturers. Vouchers (up to £35k per voucher) can cover the cost of travel, subsistence and consultancy. It can also be used to fund a maximum 6-month secondment to a facility or research group to build expertise.

LMICs are beneficiaries of this work, which will improve the supply capacity and cost base of existing vaccines and introduce new vaccine technologies to these groups. The vaccine candidates researched by the Hub are on pathogens that primarily affect low-income countries listed on the DAC list, such as malaria, Rift Valley fever, Dengue, pneumococcal disease and TB. Other DAC listed countries will benefit from Hub activities, as we will interact through the DCVMN to offer training, consultancy and secondments through interaction vouchers and feasibility projects.

Publications

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