The prevalence of food allergies is increasing globally for many reasons. Recent NHS data shows the number of emergency hospital admissions due to anaphylactic shock from adverse food reactions have more than doubled in the last 20 years. Whilst this may be down to better public awareness of allergies and intolerances, data from the Imperial Biomedical Research Centre suggests that there is a growing population-wide sensitivity to allergens.
The increase of allergy-related hospital admissions has significant implications for food manufacturers. In accordance with The Food Standards Agency’s updated labelling requirements, following the introduction of Natasha’s Law in 2021, food manufacturers must ensure that all prepacked products display a full ingredients list with any of the 14 regulated allergens clearly listed on the packaging. Identifying allergens at an early stage can help make the manufacturing process more cost effective and support risk mitigation strategies.
To help manufacturers identify allergens at an early stage, research scientists are exploring ways to improve the sensitivity, specificity, speed and accessibility of allergen detection tests. There are a number of promising emerging technologies that could be utilised for allergy detection, involving the use of nanobodies.
Historic allergen detection
When it comes to allergen detection during manufacturing, the risk of cross contamination is a major concern. Growing consumer awareness of the health risks posed by allergens means transparency and effective production management are vital.
The unintentional transfer of allergens, such as peanuts or gluten, between product lines (due to the use of shared equipment or surfaces, for example) could have serious health consequences for consumers and impact the company’s reputation.
Employing good manufacturing practice (GMP) is essential. Manufacturers must either ensure allergens are completely removed, or offer clear labelling if one of the regulated allergens is present in - or had previously been handled by - the facility. In many cases, manufacturers already have stringent processes in place to manage allergen-related risks. For example, allergen checks are typically carried out in between batches - after equipment is cleaned and before the next is produced.
Allergen detection technology
There is technology on the market that can identify allergens at an early stage in the production cycle. Current technologies include ELISA, PCR, and mass spectrometry.
What is ELISA?
ELISA relies on the use of antibodies to detect proteins associated with allergens and is often used for identifying the presence of peanuts and lactose; however, it is prone to cross-reactivity and stability issues.
What is mass spec?
Alternatively, mass spectrometry uses molecular weight and peptide fingerprints to identify allergen proteins. Recently, the Japanese food giant, Nissin Food Holdings Co Ltd filed a suite of patent applications employing the same mass spectrometry protocol to test foods for a wide range of allergens.
For example, one filed patent is for mass spectroscope technology that can detect trace amounts of salmon [JP2024177139], and another uses the same technology, but with a different protein, to detect walnut [WO2024253154].
Whilst mass spectrometry is highly accurate, it does also require specialised equipment and expertise.
What is PCR?
PCR, or polymerase chain reaction testing, is another allergen detection technology that allows for the identification of allergenic food species or ingredients. PCR technology came to the fore during the horsemeat scandal in 2013, when it played a pivotal role in detecting species-specific DNA in affected products.
Whilst current tests are effective, manufacturers need faster, cheaper, and more accurate solutions that are capable of multi-allergen or trace-level detection to comply with the Food Standard Agency’s requirements and meet consumers’ expectations.
Furthermore, new tests need to provide a rapid and easy to understand result at the point of manufacture. Scientists recognise that nanoscience could transform allergen detection, but will novel solutions be accessible and cost-effective so that it can be widely adopted across the industry?
Using nanoscience for allergen testing
Nanobodies, also known as single-domain antibodies, derived from camelid antibodies are already helping to improve allergen detection. In early-stage trials they have outperformed traditional testing methods in terms of their sensitivity, speed and scalability. For manufacturers, a key benefit of nanobody-based food allergen surveillance is that it can provide rapid results, enabling real-time identification of allergens in complex food matrices.
The complex nature of many processed foods introduces an increased risk of contamination as manufacturers can’t be sure how secure the supply chain is against allergens.
Nanoscience can bring benefits here too, through the use of ultra-sensitive nanobody biosensors. Nano-biosensors and nanobody-based immunoassays are capable of detecting allergens at trace levels with remarkable precision, targeting conformational epitopes that traditional antibodies might miss.
Nanobodies also excel in target selection due to their minimal cross-reactivity, making them ideal for detecting allergens in complex food matrices with greater accuracy.
Nankai University has recently filed a number of patent applications directed towards the use of nanobodies for use in detecting allergens associated with milk, lupins and various nuts. For example, one patent looks at the application of a specific nano antibody of milk allergen beta-lactoglobulin [CN115141274].
As research and development activity progresses, nanobody-based biosensors could also be used to create tests that can detect multiple allergens at once.
Whilst traditional methods like ELISA, PCR and mass spectrometry remain reliable for standard allergen testing applications, nanoscience offers superior allergen surveillance and opportunities for on-site analysis.
As the technology develops, manufacturers are expected to invest in new nanobody-based solutions due to their heightened sensitivity and accuracy, as well as their ability to improve food safety and increase consumer trust.
Opportunity for innovation
Whilst allergen detection is already a must-do for food manufacturers, cost and ease of use is still a barrier. However, taking learnings form other industries can help combat this.
Pivoting technologies developed from the pharmaceutical industry is enabling innovators to develop solutions that are more scalable and cost-effective.
Nanoscience is widely used in the pharma industry for disease detection and treatment, and a large amount of R&D investment has already been spent developing medical technologies. For example, a patent filed by Dots Technology Corp details the use of aptamers in the development of biosensors for allergen detection [US2021109076].
Aptamers are single stranded oligonucleotides which essentially act as small chemical antibodies which had previously been developed by the pharma industry as therapeutics and in drug screening and medical diagnostics. Similarly, patent applications directed towards microneedles, originally developed for the extended release of drugs to the skin, are now being re-purposed and developed as rapid allergen detection kits.
By drawing on this rich seam of technological know-how from other sectors, innovators can develop highly effective, nanobody-based technologies for allergen detection whilst benefiting from lower R&D costs. As nanotechnology solutions for the food industry scale and become more widespread, they will become increasingly accessible and therefore more cost-effective, paving the way for broader adoption in food safety practices.
When navigating intellectual property (IP) protection for allergen surveillance technologies, innovators must take a planned, strategic approach from the outset to ensure their advancements are properly protected. Investing in a robust IP portfolio not only differentiates a company from competitors but also opens up opportunities for licensing agreements. For example, food safety laboratories or equipment manufacturers may seek to integrate patented nanoscience tools, such as nanoparticle-enhanced biosensors, into their offerings, creating a new revenue stream for the innovator. In summary, proactive IP management can transform an innovative allergen detection technology into a highly marketable asset whilst mitigating the risk of patent infringement.
When patent applications for new nanoscience technologies are being prepared, a meticulous approach is needed, particularly when it comes to technical disclosure, strategic claims and adapting to jurisdiction-specific rules. A trusted IP partner can assess whether filing a patent application will meet the innovator’s commercial objectives and how best to go about this.
In an era where food allergies are becoming more prevalent and consumer interest in allergy detection is growing, nanoscience offers an exciting opportunity to develop tests that are effective, user-friendly and could soon be part of management best practice.
With a strategic approach to innovation and robust IP protection, these technologies could not only mitigate compliance risk but also unlock new commercial opportunities, paving the way for a smarter, safer future in food manufacturing.
Simon Bradbury, partner, and Abbie Fisher, associate, are food and drink sector specialists and patent attorneys at European intellectual property firm, Withers & Rogers.
