Impact case study database

The market for research antibodies and reagents is estimated to be worth USD10,100,000,000 [E1]. Progress has been limited by inherent challenges including antibody fragility, expense, complexity and time required to produce [E2]. Recent developments in the computational design and automated synthesis of nanoMIPs by the UoL team has meant that a reliable supply of soluble nanoparticles with predetermined molecular recognition properties, sub-nanomolar affinities, defined size and surface chemistry, is available for industrial use for the first time [R1, P1, P2], which is essential for increasing industrial capabilities. This represents significant progress, ensuring that diagnostic applications, drug discovery and the subsequent benefits to patient health outcomes can be accelerated, with creation of nanoMIPs using LBG technology taking less than two weeks on average in comparison to several months required for the development of antibodies [R1, E2]. These technological achievements were supported by several new patents enabling large-scale diagnostic applications [P1–P6].

The emergence of nanoMIPs as an alternative to antibodies in diagnostics and in vivo applications is due primarily to the research of the UoL team [E2]. As NittoDenko writes:

“The group was able to hit targets that several experienced researchers working in parallel were unable to achieve. Their use of in-silico modelling in combination with a simple, low cost, solid-phase extraction protocol was able to achieve the desired results in rapid time” [E3].

The diagnostic applications of nanoMIPs have been further supported by two new inventions:(i) Development of a novel MIP-based assay performed in magnetic microplates (culminating in translation and adoption of assays by AstraZeneca, Thermo Fisher and other companies for the analysis of blood antigens, leukotrienes, insulin and other proteins) [R2].

(ii) Discovery of a method for transforming binding events into detectable signals using redox-active nanoMIPs [P3]. This process enables integration of nanoMIPs into a broad range of sensor devices, using advanced manufacturing tools such as screen and ink-jet printers. This technology is licensed to MIP Diagnostics Limited (a UoL spinout company) with the intention of developing commercial products for a leading diagnostic company and tapping into the huge global biosensor market valued at USD18,600,000,000 [E1].

Commercialisation of nanoMIP technology developed by the UoL team has been accomplished primarily via MIP Diagnostics Limited [E2, E4]. MIP Diagnostics Limited, founded in 2013 with the intention to commercialise technology developed by the UoL team, has continued to grow over the last seven years. The original GBP1,500,000 funding came from Mercia Fund Managers. In making their decision to support the company, Mercia concluded that “recent research has highlighted the benefits of MIPs and blue-chip companies are starting to recognise their potential, in particular in applications where antibodies cannot be used. This funding will allow MIP Diagnostics to make a step change in the business, by ... developing its own products to take advantage of the huge global market” [E2].

At present, the company employs a team of 17 highly skilled scientists and engineers, currently generates over GBP750,000 in revenue per year, and has secured repeat business with a range of leading global blue-chip clients [E4]. In 2018, MIP Diagnostics Limited was recognised as the “Best MIP Commercialisation Specialists in the UK” [E5]. In July 2020, MIP Diagnostics Limited completed a GBP5,100,000 funding round to accelerate its global expansion. The co-investment has come from Mercia Asset Management, a founding investor and the largest shareholder in the company, and was led by Downing Ventures, BGF and Calculus Capital. This development enabled MIP Diagnostics Limited to grow, expand and diversify its product portfolio and capability as a result of the improved cost-efficiency provided by the use of synthetic binders rather than natural antibodies . “To date, 5 licenses have been issued, primarily to the in vitro diagnostics industry but also to some bioprocessing companies” [E4]. This is the second time that Mercia chose to invest in MIP Diagnostics, indicating their trust and confidence in the technology, and also in the future commercial success of the company.

The collaboration with the UoL team and MIP Diagnostics has continued in recent years, diversifying from diagnostics to other areas, as recognised by the company: “The research from Leicester has also led to the company building further expertise in epitope mapping [experimentally identifying the binding site of an antibody on its target antigen (usually, on a protein)] , and sensor technology which has increased our business capabilities to pursue our strategic objectives” [E5].

MIP Diagnostics is now fulfilling an increasing number of requests from major diagnostic and pharmaceutical companies for custom nanoMIP synthesis to be used in a diverse range of biomedical applications including biomedical monitoring and diagnostics. NanoMIP technology is now being applied to numerous diagnostic fields including cardiac disease, cancer and autoimmune conditions, providing high temperature resistance and excellent selectivity over traditional bioreceptors in a biosensor platform [P3]. Since its establishment, MIP Diagnostics Limited have successfully developed over 50 publicly available technologies with targets stretching from cocaine, salbutamol and copper to haemoglobin and insulin. Other examples involve development of a troponin I assay based on nanoMIP suitable for cardiovascular disease monitoring and an interference suppression solution for Veravas [E6].

This considerable success is set to continue, with planned expansion into the Oil and Gas industries as well as Security/Law Enforcement where the value and utility of nanoMIP technology is emerging. The influence on national and international law enforcement practice is via the BorderSens project for the European Union which, by 2023, will result in the creation of a portable, wireless device with the capacity to quickly test for illegal drugs and be utilised by European Border Control in the fight against organised crime. The creation of this device is dependent upon field-leading UoL research into nanoMIPs which are critical in its operation [E8].

The non-diagnostic applications of MIP technology that have an impact on healthcare evolved from collaboration with Genethon. Genethon is a non-profit biotherapy R&D organization created and funded by the Association Française Contre les Myopathies. Its mission is to design gene therapy products for rare diseases. Its work with the UoL MIPs team has been supported as part of a GBP6,000,000 EU funding (CureCN grant) [E9]. The technology developed by UoL in partnership with Genethon [P3] is being used within the Immunology and Liver disease team at Genethon to address pre-existing humoral immunity against Adeno-Associated Virus Vector, by removing circulating anti-AAV neutralizing antibodies. Genethon has acknowledged that this technology is “ a very useful tool in the gene therapy field” [E10].

The COVID-19 global pandemic has led to an unprecedented demand for rapid and accurate diagnostic solutions, to enable mass testing and screening, antigen-detecting rapid diagnostics tests are quickly being developed. In April 2020, MIP Diagnostics announced a new venture with Stream Bio, “ a company that develops and manufactures a range of transformative bioimaging molecular probes, to develop a COVID-19 antigen reagent for assays, a lateral flow Rapid Diagnostic Test and an ‘ELISA’ type assay for high throughput screening or mass testing” [E7]. MIP Diagnostics has developed a SARS-COV-2 nanoMIP demonstrating a high sensitivity and high affinity to the COVID-19 spike protein and cultured virus. MIP Diagnostics have partnered with Stream Bio to bring a ready conjugated SARS-COV-2 nanoMIP for fluorescent-based assays to market [E11].

The 2019 Clean Air Strategy, published by Defra, has been praised by the World Health Organisation as “ an example for the rest of the world to follow” [E6]. UoL research [R1–R6] has informed this strategy. “ Under Professor Paul Monk’s chairmanship, the Defra Air Quality Expert Group (AQEG) has had significant and constructive input into developing the scientific evidence base that has underpinned a wide range of the Government’s activities” [E5].

Policy Impact:

UoL research has directly informed UK government policy in respect of domestic burning. The Clean Air Strategy [E1] states: “ Not all forms of domestic burning are equally polluting. The appliance (for example, stove or fireplace), how well it is used and maintained, and what fuels are burnt in it, all make a big difference to how much pollution is produced. Significant air quality benefits can be realised through a new efficient appliance as compared with an old stove or open fire.” The AQEG report [E3] “The potential air quality impacts from biomass burning” reviewed the evidence base detailing primary research [R1, R2] from UoL on the measured impact of wood burning on the UK urban atmosphere. In February 2020, the UK government announced that sales of wet wood will be phased out by February 2021 [E6] to support the goals embodied in Schedule 12 of the Environment Bill [E2]. There is an evidenced link from the primary research [R1, R2], through the evidence translation to AQEG and policy impact: “ Short term measurements suggest a significant contribution of biomass burning to PM during winter in urban areas” [E3, E5]; “ Government takes bold action to cut pollution from household burning” [E2, E6].

Environmental Impact:

The Clean Air Strategy [E1] states: “ Whilst urban vegetation can have significant other benefits such as for noise pollution, the government’s independent scientific advisory body on air pollution, the Air Quality Expert Group (AQEG) have found that urban vegetation is not a solution to the air quality problems at a city scale”. The AQEG report [E4] “Impacts of Vegetation on Urban Air Pollution” draws on the UoL research [R3, R4, R5], which demonstrates the relatively small effects that trees have in reducing particulate air pollution on a city scale. “ A modelling study of the effectiveness of urban vegetation in reducing PM_2.5 [fine particulate matter of 2.5 microns or less] concentrations by Jeanjean et al (2017), using CFD approaches over a 2km x 2km area of central Leicester showed that the dispersive effect of trees reduced PM_2.5 concentrations by 9% while dry deposition to the trees reduced concentrations by 2.8%. Thus modelling and measurement approaches provide broadly consistent reductions in concentrations of particulate matter” [E4]. “ … the University of Leicester work on green infrastructure, highlighted in AQEG reports, directly influenced the shape of policies and commitments set out in the Strategy and the Environment Bill” [E5]. The beneficiaries of such advice are local councils and UK (and EU) bodies responsible for air quality mitigation.

Economic Impact:

The overall actions detailed in the Clean Air Strategy [E1] aim to cut the costs of air pollution to society by GBP1,700,000,000 per year by 2020, rising to GBP5,300,000,000 every year from 2030, mainly driven by reducing health and social care costs. Particulate matter, arising from pollution sources such as wood burning, is directly implicated in deleterious health outcomes. The research [R1, R2], evidence [E3], and policy link [E1, E2], as embodied in Schedule 12 of the Environment Bill [E2], are driven by the derived health and associated economic benefits for the UK public (and EU): reducing particulate matter pollution from wood burning [R1] will directly benefit health [E1, E2]. In addition, the advice on urban green infrastructure [E1, E3, E4, E5], underpinned by UoL research, drives significant avoided costs (in the order of GBPMs) for the implementation of ineffective air quality mitigation.In summary, as stated by Defra [E5]: “ the research output[s] delivered by the University of Leicester have played a relevant and directly influential role in shaping Government policy to reduce emissions of air pollution”.Prof. Monks's recognised expertise in translation of scientific information to policy impact has led to his appointment as Chief Scientific Advisor for the Department of Energy and Industrial Strategy (BEIS) from October 1^st 2020, where he continues to advise and influence the Government on matters across science and policy.