NATIONAL MEASUREMENT ANNUAL REVIEW 2017

Chemical and Bio-measurement Chemical and Bio-measurement Chemical and Bio-measurement Chemical and Bio-measurement LGC AS A NATIONAL MEASUREMENT EXECUTIVE SUMMARY

LABORATORY Welcome to this Annual Review of our measurement facilities that reside within the NML. National Measurement Laboratory Both programmes are run across the National LGC delivers state-of- We have two key roles: activities for 2017. Measurement System, with A4I targeted at UK the-art measurement industry and the NHS KTP allowing healthcare in our role as a Our research areas span This year the government announced its ambitious the opportunity to create, expand or National Measurement • ensuring trust and the sectors of advanced plans to boost within implement innovative ideas to improve the quality of Laboratory (NML). confidence in chemical therapeutics, diagnostics, the UK, with the launch of the Industrial Strategy patient care. We value our ongoing relationships with Designated for chemical and bio-measurements safety and security and white paper, and accompanying sector initiatives our UK partner and collaborator organisations, be and bio-measurement, in the UK as identified are delivered through the and Challenge Fund (ISCF). We also saw the they industry, clinical, academic or otherwise and will we have established by government strategy four core streams of: publication of the much anticipated UK measurement work ever closer with these to ensure translation of ourselves as one of the and industry needs; strategy. These developments come at the same our measurement capability for maximum economic top measurement institutes • measurement research time as the UK prepares for exiting the EU and we and social benefit. worldwide in our field. • addressing measurement • calibration facilities have revamped components of our programmes challenges of the future • reference materials to respond to this changing landscape and to In addition, we continue to perform an important As the NML we form to foster innovation, • training and consultancy. maximise alignment and impact. This includes direct role within the international metrology community, part of the UK National promoting productivity involvement in ISCF projects, such as our £2.25m supporting global consistency and traceability Measurement System and economic growth. We play a leading role award to provide measurement infrastructure to of measurement through our activities under the (NMS), a consortium of internationally to develop support UK manufacturing of future medicines; a auspices of the International Bureau of Weights and funded by the best practice and harmonise capability that will build on our expertise in the areas Measures (BIPM), the organisation that maintains UK Government Department measurements across the of oligonucleotides, biopharmaceuticals, cell-based a coherent system of units. UK industry works in for Business, Energy world, in turn providing therapies, nanomedicines and single cell and tissue international markets and our participation in these and Industrial Strategy further confidence in imaging. activities is essential in allowing us to provide (BEIS) that provides the UK’s science and services and products that are accepted globally. the core measurement technology capabilities. This year has seen a number of successes across infrastructure for the UK. all of our areas of activity. For example, we are now I would like to thank the teams responsible for one of only a few laboratories worldwide to gain delivering our work over this year for their hard ISO/IEC 17025 accreditation for the high accuracy work and commitment to maintaining the quality and quantification of extracted DNA by digital PCR consistency of chemical and bio-measurements. Through improved chemical (dPCR), thus enabling us to support molecular and bio-measurements diagnostic companies and reference materials providers to develop products for the benefit of their we support manufacture end-users. Similarly, our nanoparticle capabilities are informing new regulatory frameworks to and trade, protect enable the safe implementation of these versatile Derek Craston consumers, and enhance materials. NML-led interlaboratory studies are Chief Scientific Officer providing best practice for direct skills development analysis approaches that remove the need for sample preparation and support fields such as and quality of life. food authenticity. Finally, a novel generic approach to increase sensitivity and reduce measurement variability of routine immunoassay measurements in biological fluids has been developed and will be applied to monitor biomarkers in patients with Alzheimer’s disease.

This year we have also focussed significant energy on increasing our engagement levels with measurement stakeholders. This includes the development and launch of two collaborative partnership programmes – ‘Analysis for Innovators (A4I)’ and ‘NHS England Knowledge Transfer Partnerships (KTP)’ – that provide new direct routes for stakeholders to access the unique

1 2 2 CONFIDENCE IN MEASUREMENT THE NML AND THE GLOBAL MEASUREMENT

For governments, society and individuals to We work closely with government, academia COMMUNITY have confidence in the decisions that are based and private sector organisations to understand, on the thousands of routine measurements address, and manage the measurement We regularly coordinate and participate in made each day they must also have confidence challenges they face in order to provide practical international comparison studies between in the measurements themselves. and effective measurement solutions. National Measurement Institutes under the auspices of the Consultative Committee These measurements cover a vast array of for Amount of Substance: Metrology in applications, from clinicians making a medical and (CCQM), and are diagnosis, to laboratories providing forensic regarded as one of the top institutes for our evidence to support the justice system or designation within the global measurement tests to safeguard the quality of our water. community. Successful participation in these studies supports our Calibration and Measurement Capabilities (CMCs) claims which underpin our measurement services.

NML stakeholder In 2017 we successfully participated in 6 distribution 2017 studies (leading on 1) spanning the full range of our capabilities. Among these were a study Industry to demonstrate competence for quantifying multiple organic analytes (amino acids), where 34% we had the best results of any participant, and Government the ongoing study to measure concentration and abundance of low level cancer mutations & regulatory in the presence of high levels of normal DNA. 25%

Measurement Excellent performance at CCQM has organisations maintained the NML’s world-leading position and also led to 7 new and revised CMC claims. 1% • Inorg 033R essential elements in food and food supplements [revised] • Inorg 053 potassium in food and food supplements Other • Inorg 054 carbon isotope ratios in food and food supplements Academic 22% • Org 050 tacrolimus purity and reference 18% value (CRM/ERM-AC022)

We received the first flexible broad scope claim within the organic area. 2017 achievements in numbers 2017 stakeholders in numbers → 23 peer-review publications → 480 stakeholder interactions • Org 051-053 PDBEs, PAHs, PCBs, low → 7 new CMC claims → 302 unique institutions polarity pesticides (<500Mwt), → 24 reference materials perfluorinated carboxylic acids → contributed to 22 ISO standards (

3 CONFIDENCE IN MEASUREMENT CONFIDENCE IN MEASUREMENT 4 REFERENCE MATERIALS This year we released our Metagenomic Control Material Reference materials (RMs) are the cornerstone of accurate and traceable for Pathogen Detection (ATCC® MSA-4000™) in measurements – they are measurement standards which can be used to partnership with ATCC (American Type Culture Collection). validate analytical methods, establish traceability and support quality control. The material contains a selection of bacterial DNA species We have a portfolio of over 150 materials covering high purity standards, commonly observed in clinical infections, such as sepsis, carbon isotope ratios, food, environmental and clinical materials, and and includes organisms known to be resistant to antibiotics. alcohol standards. This year we released new materials to underpin Using our dPCR expertise, we performed quantification of therapeutic drug monitoring for transplant patients, protect food authenticity the bacterial DNA present at a range of concentrations to and safety, and support regulation around consumer products. provide customers with improved precision. This material will help researchers better understand their sequencing methods and molecular diagnostic approaches for detecting and monitoring common human diseases.

New materials released in 2017:

• Pure tacrolimus (ERM-AC022a) • Human blood - sirolimus (ERM-DA111a) • Electronic cigarette liquid – nicotine and water (ERM-DZ002a) In 2017, we became one of the few laboratories worldwide • Yeast - total chromium and chromium (III) (ERM-BD213a) to gain ISO/IEC 17025 calibration accreditation for purity • Peanut flour (LGCQC1020) of organic materials by quantitative NMR (qNMR).

Replacement materials released in 2017: Our current scope, which we shall further extend in 2018, spans organic analytes of high purity (>90%) with • Horse meat (LGC7220) a molecular weight of <1000 g/mol. This accreditation • Beef meat (LGC7221) enables us to provide faster high accuracy reference • Pork meat (LGC7222) material characterisation and measurement research • Sheep meat (LGC7223) for customers across the agricultural , • Chicken meat (LGC7224) biopharmaceutical, chemicals, consumer products and • Turkey meat (LGC7225) forensic industries. • Goat meat (LGC7226) • 1 % horse meat in beef (LGC7240) • 10 % horse meat in beef (LGC7241) • 1 % pork meat in beef (LGC7242) • 10 % pork meat in beef (LGC7243) • 1 % chicken meat in sheep (LGC7244) • 5 % chicken meat in sheep (LGC7245) • 1 % turkey meat in sheep (LGC7245) • 5 % turkey meat in sheep (LGC7247) • 1 % beef meat in sheep (LGC7248) • 5 % beef meat in sheep (LGC7249) • 15 % alcohol standard (ERM-AC405d) • 40 % alcohol standard (ERM-AC405d)

We have accreditation to ISO Guide 34 as a Reference Material Producer.

5 REFERENCE MATERIALS REFERENCE MATERIALS 6 COUNTING ON BIOLOGY In 2017, we became one of the few laboratories The successful development of personalised FOR THE FUTURE worldwide to gain ISO/IEC 17025 accreditation medicine, the diagnosis and treatment of for quantification of extracted DNA in solution by disease at the individual level, relies on droplet digital PCR, demonstrating our world-leading the quality of the samples being analysed. We are in the midst of a the comparability and inform best practice and capability to effectively and accurately measure DNA. The European project SPIDIA4P focuses bio-revolution: advances in traceability of biological develop the underpinning This accreditation supports our new dPCR facility on standardising the way in which clinical genomic and informational measurements. This delays standardisation activities. in providing reference material characterisation and samples should be collected and handled technology coupled to progress in translating quantitative measurement research for customers (pre-analytics) to enable correct disease advanced measurement at research into commercial Using these approaches we across the diagnostics, therapeutics, agricultural diagnosis. This is being done by developing the cellular and molecular applications and ultimately are now working closely with biotechnology and food industries. pre-analytical technical specifications and level are transforming our use in the clinic, and stakeholders from private external quality assessment (EQA) schemes. understanding of biology. impacts upon accreditation, industry, public institutions We will contribute our measurement expertise This will affect the future regulatory development and standards organisations to this programme, providing nucleic acid of many sectors, including and compliance. This in across a number of national We are currently involved in revising and developing material to EQA schemes, and contributing healthcare, environment, turn influences efficacy and European collaborative the following written ISO (International Organization for to European (CEN) and international (ISO) agricultural biotechnology of products and can initiatives (projects such Standardization) standards, developed by international standards development. and food, supporting compromise patient and as SPIDIA4P and EMPIR experts to help support innovation and provide applications ranging from consumer safety. Biostand [see boxes]). solutions to global challenges: monitoring viral load or These projects develop and circulating tumour cells in For biomolecular analytes, revise the standards and • ISO 17511 In vitro diagnostic medical devices - patients to identifying the where the numbers involved guidance documents needed Measurement of quantities in biological samples BioStand is an NML-led project which aims presence of genetically are very small, the seven to support the progress of - Metrological traceability of values assigned to to develop standards to support molecular modified foods. base quantities of the biotechnology and clinical calibrators and control materials (revision) diagnostic laboratories in demonstrating International System of Units diagnostics and mitigate • ISO/NP TS 20914 Medical laboratories – Practical conformity with regulatory requirements However, the new methods (SI) are not a particularly the use of inaccurate guide for the estimation of measurement worldwide. This European-funded project and technologies currently useful measure to achieve and unreliable tests. uncertainty (new standard) will use best practice guidance generated being developed will only comparability and traceability. • ISO 20395 Biotechnology – Guidelines for in previous NML-led international metrology achieve their full potential if Instead, biologists can This will help the evaluating the performance of targeted nucleic projects (Bio-SITrace, INFECT-MET) and we can ensure they are safe best be served by counting biotechnology industry acid quantification methods - part 1: qPCR and will work closely with international standards and can be implemented individual entities. The NML optimise and assess their dPCR (new standard) committees for biotechnology (ISO TC276) reproducibly. Accurate has established itself as processes, enabling data • ISO 17822-2 In vitro diagnostic test systems - and clinical laboratory testing and in vitro measurements of biological a pioneer in quantitative comparability, reducing Qualitative nucleic acid-based in vitro examination diagnostic test systems (ISO TC 212). analytes (e.g. nucleic acids, biological analysis, risks and costs and procedures for detection and identification of proteins and cells) are crucial developing novel and highly ultimately supporting microbial pathogens - Part 2: Quality practices for to their development. accurate reference methods regulatory confidence and nucleic acid amplification (new standard) and driving and supporting compliance to facilitate There is currently a lack key initiatives in this area international trade. of reference methods to establish the necessary and standards to support measurement framework, The NML-proposed text describing how cellular or biomolecular entities can be counted in a traceable way will be included as part of the revision of the SI Brochure (9th edition) alongside the revision of the SI which is expected to be ratified at the General Conference on Weights and Measures (CPGM) in 2018.

7 COUNTING ON BIOLOGY FOR THE FUTURE COUNTING ON BIOLOGY FOR THE FUTURE 8 MEASUREMENT SUPPORTING THE NHS: "I am delighted to be NEWBORN SCREENING working with the National Measurement Laboratory, We are working in material development at approaches to clinical collaboration with NHS the NML with the clinical measurement to other and by extending the England through a experience of Dr Rachel laboratories involved in Knowledge Transfer Carling, Consultant Clinical the screening process. collaboration to include the Partnership (KTP) to support , Director of These improvements the Newborn Blood Spot Service and Clinical Lead, are aimed at reducing UK Newborn Screening Screening programme. Viapath, Guys & St Thomas' the possibility of false The Newborn Screening NHS Foundation Trust. positives occurring, which Laboratory Network, I am programme impacts on cause unnecessary stress every child born in the This work aims to further to parents and increase confident that we can UK, identifying babies improve the methodology workloads of clinicians. further improve the who may have rare and which underpins the reference material. screening programme, methodology which supporting harmonisation The KTP brings together the of the results. It will further underpins the screening mass spectrometry expertise disseminate best practice and experience in reference for statistical and mass programme." method and reference spectrometry-based

Dr Rachel Carling, Consultant Clinical Scientist, Director of The NHS Chief Scientific Officer's Knowledge Transfer Partnerships (KTP) is a 12 Service and Clinical Lead, Viapath, month programme started in 2017 that runs in partnership between NHS England Guys & St Thomas' NHS Foundation Trust and three UK National Measurement System (NMS) laboratories (LGC NML, National Physical Laboratory (NPL) and the National Institute for Biological Standards and Control (NIBSC)). It provides clinical leaders in healthcare science access to the unique capabilities within the National Measurement System to identify new approaches to measurement within their fields of expertise, ultimately helping to improve patient care.

Due to the success of the first programme, a second round will be launched in 2018. This will allow for a greater number of KTPs targeted to the areas of mutual interest between the NHS and the research and innovation infrastructure within the UK.

9 MEASUREMENT SUPPORTING THE NHS MEASUREMENT SUPPORTING THE NHS 10 A PATIENT-CENTRED APPROACH: BETTER MEASUREMENTS FOR NEURODEGENERATIVE DISEASES

Neurodegeneration is and costing around $800 a currently incurable, billion per year in social debilitating process. and medical care. Alzheimer’s and Parkinson’s disease are two of the most The NML is leading common neurodegenerative a European-funded diseases and present a multidisciplinary growing global challenge due project (NeuroMET) to to our ageing population. develop a clinical and While the symptoms may measurement framework be different, there are to improve the accuracy of similarities between the neurodegenerative disease underlying changes to the measurements. Working brain in each disease as together with patients, both involve the build-up the project will develop of specific proteins in the diagnostic protocols, brain and the destruction reference methods and of brain cells. In the late patient-centred outcome stages of both diseases, measures that are linked the neurodegeneration can for the first time with ultimately lead to dementia, clinical laboratory data. a condition affecting over 46 million people globally

We are helping to improve same protein in saliva so a validated for peptides found measurement comparability less invasive sample can in Alzheimer’s patients of biomarkers; these can be taken. In combination (Aβ40, Aβ42) and which either be used for disease with other approaches will be applied alongside diagnosis or to support (including MRI, spectroscopy, routine immunoassays the development of novel immunoassay and dPCR) it to the patient cohort. therapeutics. Building on will be used to assess the our expertise in protein potential for alpha-synuclein The NeuroMET consortium quantification, we are to be used as a biomarker includes clinical developing a reference for Alzheimer’s disease. laboratories, hospitals measurement procedure for and biopharmaceutical quantification of a recognised Within NeuroMET we are companies to ensure the therapeutic target for also aiming to increase results of this project are Parkinson’s disease (alpha- sensitivity and reduce delivered directly into the synuclein) in cerebrospinal measurement variability clinic for the benefit of fluid. This approach will be of routine immunoassay patients. This will support applied to a Parkinson’s tests in biological fluids the provision of earlier and patient cohort and compared for diagnosing Alzheimer's more accurate diagnosis, with results from routine disease. The NML has more effective treatment immunoassay tests. In developed a novel generic and improve monitoring addition, our method will approach which has been of disease progression. be tailored to quantify the

11 PATIENT-CENTRED APPROACH PATIENT-CENTRED APPROACH 12 A CHALLENGE FOR OUR TIME: The NML is helping to ensure that research into a cure ANTIMICROBIAL RESISTANCE for HIV is based on sound fundamental measurements. Recent work by NML scientists comparing different molecular methods (qPCR, dPCR) for quantification of Without action, antimicrobial example to screen patients ultimately support screening HIV DNA has raised some concerns around the current resistant infectious diseases for MRSA, method uptake approaches for MRSA to help popular choice of calibrator used to compare results are estimated to account for is slow as laboratories inform treatment choice. between HIV clinical studies. It appears to lose HIV a staggering 45% of global are unclear about test DNA copies during cell growth, potentially producing deaths, potentially as many accuracy and support for Working with hospitals misleading estimates of how much HIV DNA is present as 1 every 3 seconds, by quality assurance is in and key stakeholder and affecting whether novel strategies towards curing 2050, while also ending its infancy. As part of the charities we are supporting HIV are deemed successful or not. advances in medicine in NML-led European-funded the standardisation of areas such as surgery project (AntiMicroResist), comparable and traceable Based in part on our work, the NIH AIDS Reagent and cancer treatment. we have developed a novel measurements in this area Program, which provides critical reagents and resources reference method for MRSA to deliver a step change in to support research in the areas of AIDS therapeutics Today our physicians are not and produced a prototype how microbial resistance and vaccine development, has recently highlighted armed with the diagnostic reference material which will is evaluated, treated and the potential instability of the calibrator on its reagent tests to quickly guide be distributed as part of an managed in the future. database to support the research community and treatment to reduce and external quality assurance enable the best chances of success. treat resistant pathogens. scheme. This will be used Where examples exist for to assess laboratory and more rapid methods, for method performance and Biofilms are central to some of the most urgent global challenges. A biofilm is an association of micro- organisms in which cells stick to each other on living or non-living surfaces. They form in virtually every imaginable environment on Earth and they are a leading cause of antimicrobial resistance, forecast to be a major cause of death by 2050. The UK’s world-class expertise in research in this area was recognised this year through the launch of the new National Biofilms Innovation Centre (NBIC), a multi-site Innovation and Knowledge Centre led by the University of Southampton.

Over the next five years, the NML will provide measurement support for the NBIC, focusing on the measurements required to determine the mechanisms of biofilm formation in hospital-acquired infections that can lead to antimicrobial resistance.

13 A CHALLENGE FOR OUR TIME A CHALLENGE FOR OUR TIME 14 RELIABLE DIRECT Scotch whisky is responsible for a quarter of MEASUREMENT all UK food and drink exports. The protection MASS SPECTROMETRY: of this premium product from food fraud or SUPPORTING REMOVING THE adulteration is crucial in maintaining the global market. INNOVATION NEED FOR SAMPLE The NML has been working with the Scotch As the NML we support innovation within PREPARATION Whisky Research Institute and King’s College measurement science, providing novel London to test the feasibility of transportable measurement solutions to bridge the gap from Ambient ionisation technology can be used to rapidly ambient ionisation mass spectrometry to fundamental research to application in industry. analyse samples without the need for sample preparation provide useful fingerprint information on or , for example to analyse pharmaceuticals various types of Scotch whisky. These By responding to new measurement challenges directly from tablets, detect or determine the signatures will aid detection of counterfeit and as they develop, we can support industry to authenticity of food and drinks. With the recent growth and adulterated Scotch whisky and this approach make positive changes, improve processes and availability of commercial direct ambient ionisation sources, has the potential to be developed across the technologies more quickly and effectively, and these techniques have been adapted across a wide range of wider drinks industry. reduce the risks associated with development. industries, including healthcare, forensics, security and food. This will help to increase productivity and improve quality of life across the UK.

However, there are significant measurement challenges with this type of technology, particularly around repeatability and robustness of the techniques and the effects of background interferences which are typically greater than those observed using traditional approaches. The NML led a second interlaboratory study (the first study was in 2015) involving 15 laboratories to assess these specific characteristics and help ensure that ambient ionisation applications are effective and reliable.

These results, which were presented at the annual British Mass Spectrometry Meeting, confirmed the best approach for obtaining repeatable data for ambient ionisation (the use of a matched internal standard). The data obtained from this study has been well received in the ambient ionisation community and is being used along with the data from the first study to progress the NML’s ongoing work in transportable mass spectrometry.

15 MEASUREMENT SUPPORTING INNOVATION MEASUREMENT SUPPORTING INNOVATION 16 The NML is co-ordinating the first international We were invited to contribute to a workshop on NANOMATERIALS measurement comparison study between regulatory preparedness run by the EU-funded National Measurement Institutes (under the project NanoReg 2, informing regulators and Nanomaterials and in ensuring that the full separation technique (field auspices of the CCQM) on the determination industry on reference material production and nanotechnology potential of nanotechnology flow fractionation, ISO TS of number concentration of nanoparticles the current state-of-the-art for single particle developments are having is realised and that it is 21362). These standards (colloidal gold). An interlaboratory comparison nanomaterial analysis using inorganic mass an increasingly significant safely integrated into society. have been produced as a using the same material that is open to spectrometry (spICP-MS) measurement. impact on human life, from response to the worldwide industrial and academic laboratories with an enabling more targeted As the NML we have demand for suitable interest in nanoparticle analysis will be run in cancer treatments to been instrumental in methods for the detection parallel through VAMAS (Versailles Project improving the efficacy of developing new international and characterization of on Advanced Materials and Standards) in vaccines or the delivery of documentary standards (ISO) nanoparticles in food and collaboration with NPL. This will allow a agrochemicals. However, to support this field. For consumer products. comparative evaluation across users and their small size can lead to example, we provided expert measurement institutes and may lead to the potentially toxic effects. To input into a newly released In addition, we provided development of new international written protect human health and the Technical Specification the particle size reference standards to support regulation around environment, it is crucial that (ISO TS 19590:2017) that measurements for a nanoparticles. we are able to characterise outlines a novel method new silica reference nanomaterials effectively and (single particle inductively material (ERM-FD101b) understand their behaviour coupled plasma-mass released this year by the within biological systems. spectrometry, spICP-MS) European Commission for determining the size (EC JRC Directorate F Significant efforts are distribution and concentration (Health, Consumers and being made to ensure the of nanoparticles in aqueous Reference Materials). This appropriate regulatory samples. We have been material will support the frameworks are in place invited to provide the UK implementation of the EC to support this enabling expert view for a new definition of ‘nanomaterial’. technology. National and standard on the analysis of international standardisation nano-objects using a gentle efforts play a critical role

17 NANOMATERIALS NANOMATERIALS 18 ANALYSIS FOR ANALYSIS FOR INNOVATORS Sistemic Cell therapies are seen as the future of treatment in a number of areas including INNOVATORS Alongside NPL, NEL and diabetes and cardiovascular disease. However, one of the types of cell being used to STFC, the NML is a partner in generate cell therapy products (pluripotent stem cells, PSCs) has the potential to form "Using NMS services increases the new Innovate UK funding programme ‘Analysis tumours, raising concerns around product safety. The NML enhanced the sensitivity and company survival rates, particularly for Innovators’ (A4I). A4I provides companies specificity of the Sistemic Ltd novel prototype miRNA-assay to the levels required for with access to state-of-the-art measurement and market (<10 cells per million). This assay will ensure producers can accurately assess for young companies. Support from analytical technologies. It focuses on solving PSC contamination in their cell therapy products. NMS laboratories can increase measurement problems within existing business employment by 10%–15% within to improve competitiveness and productivity. “We are delighted to have worked with LGC, utilising their expertise as the two to four years." National Measurement Laboratory for chemical and bio-measurement. The This year we have been working with five micro - Frontier Economics Study (The impact and small UK companies to address challenges successful outcome of this project has the potential to facilitate the clinical of public support for innovation on firm in healthcare, food and bioscience development. progress of pluripotent stem cell-derived cell therapy products, allowing them outcomes (BEIS Research Paper These projects address challenges in quality to be developed to safer clinical products more quickly.” Number 3)) control to reduce wastage, product improvement to provide regulatory support, and the extension David Mallinson, Vice President of Scientific Operations, Sistemic of current products to access new markets.

Following the successful uptake of A4I, a second round of this programme will be launched in 2018. AirQualityResearch

Novel technologies and solutions for wastewater The Coconut Collaborative management are necessary for the UK to meet its sustainability goals, reducing Ensuring consistent food quality throughout the supply water wastage and reusing resources where chain is critical for the success of food businesses. possible. Air Quality Research Ltd currently develops The NML worked with the Coconut Collaborative Ltd, a bespoke chemical-free, energy-saving products manufacturer of coconut yogurt, and STFC, to develop a for bacteria control and chemical contamination, rapid and robust screening approach to detect rancidity providing safe fluids for use in the home and in coconut cream. The unwanted use of a barrel of industry. By working with the NML, they sought to coconut cream tainted by rancidity in the manufacturing increase further the efficiency of their treatment process renders it unsuitable for sale and consumption process for application to wastewater treatment for and can lead to entire batches of coconut yogurt being process industries, reducing costs and improving rejected. The novel screening approach developed at the their potential for water reuse. NML (multi-spectral imaging), which replaces the current manual ‘taste test’, will help avoid annual costs in excess “We value the measurement support of £500k through reduced production and material provided by the NML, to enable us charges. to solve this technical challenge. As “The A4I project a small innovation company with a collaboration has been platform technology, finding the right incredibly valuable to the solution to this measurement challenge Coconut Collaborative is almost as difficult as the challenge Ltd. It has enabled us to work in a time itself! We have been very impressed efficient way with world class institutions with their approach and look forward to and scientists to develop and prove a a continued collaborative relationship.”

principle for solving a very unique but real Peter Kukla, Managing Director of AQR rancidity measurement problem. We are impressed with the encouraging results.”

James Averdieck, Managing Director

19 ANALYSIS FOR INNOVATORS ANALYSIS FOR INNOVATORS 20 MEASUREMENTS FOR FUTURE MEDICINES The NML is a partner, alongside NPL, NIBSC and Imperial College London's SynbiCITE, in a new virtual laboratory funded by the ISCF to establish The NML has been awarded £2.25m by The ‘Measurement for Future Medicines’ project, a UK Centre for Engineering Biology, Metrology the Industrial Strategy Challenge Fund started at the end of 2017, will further establish and Standards. The new £7m virtual laboratory (ISCF) to support the manufacture of future the NML’s state-of-the-art capabilities and promote aims to develop and provide relevant reference medicines through better measurement. best measurement practice in manufacturing materials and methods to help convert innovation and clinical settings to enable the accurate and in synthetic biology into valuable products The UK has seen unprecedented health outcomes reproducible manufacture of future medicines. and services. The NML will provide specialist and life expectancy gains over the last 30 years expertise in biological standardisation of genomic based on sound medicinal improvements. Recent This work builds on our measurement expertise in measurements. advances are set to see this trend continue the areas of oligonucleotides, biopharmaceuticals, through the development of a host of new types of cell-based therapies and single cell and tissue Establishing industry-led measurements and medicines: so-called advanced therapy medicinal imaging. Through close collaboration with regulators, standards will safeguard the quality and safety product (ATMPs) based on genes, cells or tissues, the Cell & Gene Therapy Catapult, academic of products, and allow companies to maintain in addition to novel oligonucleotide and protein centres of excellence and industry partners, competitiveness and enhance innovation in fields based therapies. However, due to their complexity, this project will help underpin productivity gains such as the discovery and manufacture of new manufacturing processes for many of these products and innovation improvements in this area. antibiotics. are setting new challenges in terms of guaranteeing consistency of manufacture to ensure their It will ensure the UK maintains its world- safety. Such novel processes will rely, of course, leading position within the pharmaceutical on the accurate measurement, characterisation sector and continues to drive international and behaviour of these medicines, both at their best practice, ultimately leading to greater place of manufacture and within our bodies. confidence in the safety of our medicines.

21 MEASUREMENTS FOR FUTURE MEDICINES MEASUREMENTS FOR FUTURE MEDICINES 22 PEOPLE KNOWLEDGE TRANSFER

Philip Dunn was elected an Associate Member and became a Certified Cytometrist. & DISSEMINATION of the International Union of Pure and Applied Chemistry (IUPAC) Commission of Isotopic Abundances and Atomic Weights (CIAAW), TRAINING FOR THE FUTURE making him only the ninth person with the UK affiliation since 1902. LGC has over 20 years’ Jim Huggett was made a Fellow of the Royal experience in delivering In 2017 we delivered: College of Physicians of Edinburgh (FRCP analytical quality training - 31 courses (Edin)) in recognition of the medical focus of programmes to customers - in 14 countries the research he and his team have conducted worldwide. The courses focus - to 359 delegates on the development and standardisation of on providing analysts with the - from 94 organisations molecular diagnostics. tools to ensure the validity of The NML is playing a key role in a their measurement results. new initiative focused on developing Denise O’Sullivan was invited on to the new talent and providing the UK with Steering Committee for the International a community for chemical and bio- Metagenomics and Microbiome Standards We have an extensive Using proficiency testing analytical measurement science. Alliance (IMMSA), an association of programme of courses in the analytical laboratory CAMS-UK is an industrially-led microbiome-focused researchers from industry, delivered from our – Learn how to get the membership network developed in academia and government, that will be headquarters in Teddington maximum benefit from response to the Royal Society of coordinating cross-cutting efforts to address or at customer sites and participation in proficiency Chemistry (RSC) Analytical Division microbiome and metagenomics measurement customised, if required, testing schemes analytical landscaping exercise in 2015 challenges. to meet specific training and the subsequent 2016 Engineering requirements. Reference material and Physical Research Council Heidi Goenaga Infante was invited by the production – Planning (EPSRC) review of analytical science. division of IUPAC to join Topics covered include: effective reference material their task group that will critically evaluate characterisation studies CAMS-UK is designed with the intention the current sampling and analysis methods Method validation – Learn to meet the requirements of bringing cohesiveness to the analytical and standardised protocols available for how to demonstrate that test of ISO Guide 34 measurement science community and nanomaterials. methods are fit for purpose aims to: Our courses consistently Julian Braybrook was awarded an honorary Evaluating measurement receive excellent feedback • Raise the profile of UK analytical Doctor of Science for his contribution to uncertainty – The principles from delegates and we measurement science training and chemistry by Kingston University. Julian and practice of estimating have a high level of repeat research received the degree from Professor Lucy Jones, measurement uncertainty customers. Over 96% of • Facilitate industrially-led innovation Vice Dean of Life Sciences, Engineering and in testing laboratories delegates who completed in novel point-of-use measurement Chemistry. a course feedback technologies Statistics for analysts – questionnaire in 2017 • Provide a talent pool with industry- Fahmina Fardus-Reid was awarded her PhD Getting the most from data stated that the training ready transferable skills for the future from Kingston University with the thesis title generated in the laboratory met their expectations. • Facilitate access across the “Extending metrological traceability in qNMR UK community of analytical beyond the first dimension”. Designing effective Details of all our training measurement laboratories, training experiments – Learn how programmes are available at providers, research and commercial John Entwisle was awarded Chartered to plan, execute and analyse www.lgcgroup.com/training. innovation organisations. Scientist certification by the Science Council efficient experiments in recognition of his current responsibilities for Gaining significant momentum over the characterisation of ethanol certified reference Understanding ISO/IEC last 18 months CAMS-UK has secured materials (CRMs) as a UKAS calibration analyst 17025 requirements for financial support from the Analytical and as a technical manager for the alcoholic analytical laboratories Chemistry Trust Fund. With industry, beverage analysis area. – Improving awareness of UK Research and Innovation and the technical requirements government organisation interest, Tamara Lekishvili passed the International of ISO/IEC 17025 CAMS-UK is due to launch formally Cytometry Certification Examination (ICCE) in January 2019.

23 PEOPLE KNOWLEDGE TRANSFER & DISSEMINATION 24 SELECTED PUBLICATIONS Do you have a measurement-related question? The quality and credibility of our science is demonstrated in part through our publications in peer-reviewed journals. In 2017 LGC experts published 23 scientific papers. Here is a selection: Are you looking for measurement support to address your measurement challenges? Busby E et al. Instability of 8E5 calibration Dunn PJH et al. CCQM-K140: carbon stable isotope standard revealed by digital PCR risks inaccurate ratio delta values in honey. Metrologia (2017) 54 quantification of HIV DNA in clinical samples by Tech Supp. DOI:10.1088/0026-1394/54/1A/08005 Contact us to access expertise in a range of chemical and biological qPCR. Sci Rep (2017) 7:1209. DOI: 10.1038/ measurement technologies and related topics such as analytical quality s41598-017-01221-5 Nunez S et al. A species-specific double isotope assurance, method validation, measurement uncertainty, reference dilution strategy for the accurate quantification materials and proficiency testing. Pang S & Cowen S. A generic standard additions of platinum-GG adducts in lung cells exposed to based method to determine endogenous analyte carboplatin. J Anal Atom Spectrom (2017) 32:1320- [email protected] concentrations by immunoassays to overcome 1330. DOI:10.1039/C7JA00078B part of themed +44 (0)20 8943 7393 complex biological matrix interference. Sci Rep collection in memory of Professor Joe Caruso (2017) 7:17542: DOI:10.1038/s41598-017-17823-y Taylor A et al. Atomic spectrometry update: review Bath SC et al. Iodine concentration of milk- of advances in the analysis of clinical and biological alternative drinks available in the UK in comparison materials, foods and beverages. J Anal At Spectrom to cows’ milk. Br J Nutri (2017) 118(7):525-532. (2017) 32:432-476. DOI: 10.1039/C7JA90005H DOI:10.1017/S0007114517002136 Lekishvili T & Campbell JJ. Rapid comparative Torma AF et al. Candidate liquid chromatography immunophenotyping of human mesenchymal mass spectrometry reference method for the stromal cells (hMSCs) by a modified fluorescent cell quantification of the cardiac marker 1-32 B-type barcoding (FCB) flow cytometric assay. Cytometry Natriuretic Peptide. Clin Chem Lab Med (2017) A (2017) DOI:10.1002/cyto.a.23248 55(9)1397-1406. DOI: 10.1515/cclm-2016-1054 Cryar A, Groves K & Quaglia MJ. Online Hydrogen Petrov P et al. Interference-free determination Deuterium Exchange Travelling Wave Ion Mobility of sub ng∙kg-1 levels of long-lived 93Zr in the Mass Spectrometry (HDX-IM-MS): a systematic presence of high concentrations (µg∙kg-1) of 93Mo evaluation. J Am Soc Mass Spectrom (2017) and 93Nb using ICP-MS/MS. Anal Bioanal Chem 28(6)1192-1202. DOI:10.1007/s13361-017-1633-z (2017) 410(3):1029-1037. DOI:10.1007/s00216- 017-0635-9 part of ABC’s 16th Anniversary Edition showcasing research from the diverse and exceptional Editorial Board

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