Impact case study database
- Submitting institution
- The University of Bath
- Unit of assessment
- 8 - Chemistry
- Summary impact type
- Technological
- Is this case study continued from a case study submitted in 2014?
- No
1. Summary of the impact
Research at the University of Bath into the development of oligonucleotide sensors using electrochemical signals led, in the REF period, to:
USD55,000,000 of new venture capital investment in a spin out company, Binx Health (formally Atlas Genetics), to make a total of USD115,000,000 raised by the company since its formation;
The development of US Food and Drug Administration (FDA) and European CE Mark approved point of care test for sexually transmitted infections, chlamydia and gonorrhoea in 2019. By delivering accurate results within 30 minutes, this platform allows patients to receive treatment immediately, stemming the further spread of disease.
2. Underpinning research
The World Health Organization (WHO) estimates each year there are 127,000,000 new chlamydia and 87,000,000 new gonorrhoea infections globally. It is common for sexually transmitted infections (STIs) to be present without visible symptoms. With current central laboratory testing, patients can receive their results anywhere from 2 to 14 days later, which contributes to the onward transmission and rapid spread of STIs. Rapid diagnosis of sexually transmitted infections is required to ensure patients obtain diagnosis and comply with treatment prior to having further sexual contact. It is recognised that a significant proportion of patients seeking treatment at sexual health clinics following initial consultation and genital swabbing do not wait for their results, and thus can become key transfection nodes in the epidemiology of STI infection though a population. However, a rapid test (less than 30 minutes) should ensure patients remain in-situ to receive a diagnosis and treatment plan. This is the rationale for Binx Healthcare’s rapid STI test.
Professor Chris Frost leads research into the synthesis of electrochemically active ferrocene labels incorporating sites for conjugation to peptides and oligonucleotides. The detection of specific oligonucleotide sequences using electrochemistry has significant advantages over existing optical technology: no need for optical sample transparency; direct signal read-out; ease of miniaturisation and low-cost device manufacture with potential point-of-care (POC) applications. University of Bath research since 2001 developed an oligonucleotide sensor based on electrochemical detection, with an assay based on the appearance of a distinct electrochemical signal when a ferrocene label is cleaved from an oligonucleotide probe. The higher diffusion mobility and enhanced access of the enzymatically cleaved ferrocene label to the electrode surface results in an increase in ferrocene oxidation current. The labelled oligonucleotide probe is designed with a complementary sequence to a unique section of target DNA and by treating with an exonuclease enzyme that selectively digests hybridised DNA, the cleavage of the label from the probe and appearance of a signal occurs only when the target is present. This allows the sensing of any particular oligonucleotide sequence by a sensitive and rapid “switch on” electrochemical signal [1,2]. The ferrocene labels were designed and prepared in Bath and the initial research followed by collaborative knowledge transfer funding generated key intellectual property for a simple, widely applicable assay for detecting DNA targets [3-5].
This research led to the launch of a University spin out Atlas Genetics in 2005 (renamed Binx Health in 2018), to develop ultra-rapid point-of-care tests for infectious diseases based on the described ferrocene reagents and electrochemical assay [1-6]. The platform consists of a small, benchtop instrument and single-use, assay-specific cartridge that can process an unprocessed patient sample with no user interaction once the sample is added to the cartridge. The cartridge has the ability to test for up to 24 targets. To achieve this requires multiple ferrocene labels that produce unique electrochemical signals. Using specific chemical methodology, University of Bath researchers were able to modify ferrocene to afford access to novel compounds with distinct oxidation potentials [3,4]. The successful development of the requisite multiplex ferrocene labels for attachment to oligonucleotide probes for the detection of chlamydia (CT) and gonorrhoea (NG) has been led by Frost at University of Bath during the REF period with the establishment of a new post for a senior chemist, 3 days per week at Bath and 2 days per week at Binx Health.
3. References to the research
[1] Hillier, SC, Flower, SE, Frost, CG, Jenkins, ATA, Keay, R, Braven, H & Clarkson, J 2004, 'An electrochemical gene detection assay utilising T7 exonuclease activity on complementary probe-target oligonucleotide sequences', Electrochemistry Communications, vol. 6, no. 12, pp. 1227-1232. https://doi.org/10.1016/j.elecom.2004.09.019
[2] Hillier, SC, Frost, CG, Jenkins, ATA, Braven, HT, Keay, RW, Flower, SE & Clarkson, JM 2004, 'An electrochemical study of enzymatic oligonucleotide digestion', Bioelectrochemistry, vol. 63, no. 1-2, pp. 307-310. https://doi.org/10.1016/j.bioelechem.2003.10.028
[3] Marsh, B, Frost, C & Pearce, D Dec. 27 2013, 1,1 '-[[(SUBSTITUTED ALKYL)IMINO]BIS(ALKYLENE)]BIS-FERROCENES AND THEIR USE IN I ELECTROCHEMICAL ASSAYS BY LABELLING SUBSTRATES OF INTEREST, Patent No. WO2013190328(A1). https://worldwide.espacenet.com/publicationDetails/biblio?II=0&ND=3&adjacent=true&locale=en_EP&FT=D&dat
[4] Marsh, B, Sharp, J, Flower, S & Frost, C Jun. 28 2012, Novel Ferrocene Labels For Electrochemical Assay and Their Use in Analytical Methods, Patent No. WO 2012/085591 A1. http://worldwide.espacenet.com/publicationDetails/biblio?CC=WO&NR=2012085591A1&KC=A1&FT=D&ND=3
[5] Marsh, B, Frost, C & Sharp, J Apr. 16 2015, Labelling compounds and their use in assays, Patent No. WO2015052516A1. https://worldwide.espacenet.com/publicationDetails/biblio?II=0&ND=3&adjacent=true&locale=en_EP&FT=D&da
[6] Marsh, BJ, Hampton, L, Goggins, S & Frost, CG 2014, 'Fine-tuning of ferrocene redox potentials towards multiplex DNA detection', New Journal of Chemistry, vol. 38, no. 11, pp. 5260-5263. https://doi.org/10.1039/c4nj01050g
Funding
G1: TCS Programme grant (Company partner-Molecular Sensing plc, 2001-2003). Value GBP94,320. Title- To develop the synthesis of redox active chemical probes and investigate their application in the sequence specific detection of DNA. Prof C. G. Frost (PI) Other investigators-Dr John Clarkson (MS), Dr Toby Jenkins (Bath); KTP Programme grant (Company partner-Molecular Sensing plc, 2005-2008). Value GBP150,930. Title- To develop the synthesis of redox active chemical probes and investigate their application in the sequence specific detection of DNA. Prof C. G. Frost (Co-I) Other investigators-Dr John Clarkson (MS), Dr Toby Jenkins (Bath).
G2: Direct industrial funding from Binx Health to University of Bath (2011-2018). Value GBP420,480 for the project The Synthesis of Multiplex Labels For Point-of-Care Diagnostics. Prof C. G. Frost (PI).
4. Details of the impact
Binx io is a small, desktop instrument that processes a single-use, assay-specific cartridge for the detection of sexually transmitted infections (STIs) with no sample preparation necessary. The point of care (POC) instrument developed by Binx Health combines ultra-rapid, polymerase chain reaction (PCR) amplification with sensitive electrochemical detection technology developed by Bath Chemistry. Binx io is fully automated and easy to use. Simply load the cartridge into the device and in about 30 minutes, the io provides easy-to-understand results allowing “test and treat” to become a reality.
Key impacts from this work are investment, people and a new technology
SME has generated investment raising a total of USD55,000,000 venture capital investment (Series C in 2015 and Series D in 2017) [C];
Creation of highly skilled jobs (growing to 43 FTE), recruitment of industry leaders, including from an environment for career development (KTP Associate with University of Bath progressed to Chief Technical Officer) [B];
A new diagnostic technology has been tested and approved for sale (successful clinical trials of the binx io platform in 2019 led to European CE Mark approval and FDA 510(k) clearance in the US to test and treat women for chlamydia and gonorrhoea) [I].
The Chief Technical Officer at Binx Health said: “ In August 2019, we received 510(k) regulatory clearance from the U.S. Food and Drug Administration for our chlamydia and gonorrhoea test (CT/NG). This marks a huge milestone for the company, and one drawn from many years of development from the original research at Bath. The key contribution from the Chemistry collaboration has been the design and synthesis of novel ferrocene labels that can be tagged onto different target oligonucleotide sequences and used in a multiplex assay as in the CT/NG test” [A].
Economic, Wealth and Opportunity Creation
Atlas Genetics was launched in 2005 with GBP500,000 initial funding, 50% of which came from the Sulis Seedcorn Fund, established by the University of Bath to provide support for new businesses. Since 2014, the diagnostic platform incorporating the Bath electrochemical technology has been manufactured, tested and approved for sale. In 2018, the company rebranded to Binx Health in preparation for the global launch of the POC platform, the binx io. Concurrently, the company opened an office in Boston, US to focus on delivering successful clinical trials, sales and marketing in the US. The company also added healthcare leaders in new roles on the management team [B]. The number of full-time staff across both sites increased to 43, the majority of whom have higher education qualifications in science (MSc/PhD), engineering (BEng/MEng) or business (MBA).
Binx Health is currently venture capital funded and to date has raised approximately USD115,000,000. During the REF period this has included completion of Series C (in 2015) and Series D (in 2017) financing, raising USD55,000,000 to specifically fund the clinical trials, device manufacture and commercial launch of a dual test for the electrochemical detection of chlamydia and gonorrhoea [C].
The io cartridge was developed in collaboration with Bespak, a global market leader in the development and manufacture of medical devices. The manufacturing line for the io cartridge has been established within dedicated purpose-build ISO Class 8 cleanroom at the Bespak site in Kings Lynn, UK. This strategic investment in UK manufacturing will facilitate the future scale-up in capacity for Binx products [D].
Clinical Implementation
The electrochemical technology at the core of the binx io tests offer a time-to-result turnaround of less than 30 minutes, which enables the opportunity to test and treat in near-patient settings reducing the spread of infections for millions who require screening under medical guidelines. The pathway to regulatory clearance and European CE Mark approval has involved clinical trials with Public Health England (PHE) and the National Institutes of Health (NIH) in the US [E]. In 2018, a team at Johns Hopkins University tested binx’s rapid POC test for chlamydia at clinics in Maryland and Ohio. The study, consisting of 296 recruited patients, determined the binx test provided an accurate positive result 93% of the time and an accurate negative result 99% of the time for vaginal self-obtained swabs [F]. In 2019, the company completed a 1,523-person, multi-centre clinical study on the binx io in a POC setting. The outstanding results showed a 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhoea in women tested. Binx received its CE Mark for CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) in May 2019 [G] and FDA 510(k) clearance in August 2019 [H, I].
In the first “real world” use, a collaboration with 3 NHS Trusts and St. Georges University of London, the binx io platform is being used by clinicians to diagnose patients who otherwise would have faced up to several days of delay between infection, identification and treatment. Clinical consultant Lewisham and Greenwich NHS Trust said: " So far, we have tested about 90 patients, have had 17 CT and two NG positives and were able to provide the right antibiotic in a single visit. British Association of Sexual Health and HIV quality standards suggest treatment within three weeks of testing. We can now provide the right antibiotic in one visit. This is game-changing for us" [J].
5. Sources to corroborate the impact
[A] Letter of evidence of impact, CTO Binx Health. 18 September 2020
[B] Company rebranding to Binx Health and key talent added to workforce. https://mybinxhealth.com/news/atlas-genetics-announces-company-rebranding-changes-name-to-binx-health/
[C] Series C (in 2015) and Series D (in 2017) financing raises $55 million to finance the clinical trials and commercial launch of a test for the detection of both chlamydia and gonorrhoea.
https://mybinxhealth.com/news/atlas-genetics-raises-35m-in-series-d-fundraising/
[D] Development of io cartridge and establishment of manufacturing capability at Bespak UK. https://www.consortmedical.com/news/atlas-completes-development-io-cartridge/
[E] February 2016 – Proprietary chlamydia test receives European CE Mark approval. https://www.prnewswire.com/news-releases/atlas-genetics-gains-ce-approval-for-first-product-567999661.html
[F] November 2018 – Completion of a successful pilot study for binx’ rapid POC test for chlamydia funded by the United States’ NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). Widdice, LE, Hsieh Y, Silver B, Barnes M, Barnes P, Gaydos CA. (2018), 45, 723. Sex Transm Dis. Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and Women's Attitudes Toward Point-Of-Care Testing. DOI: 10.1097/OLQ.0000000000000865
https://www.nibib.nih.gov/news-events/newsroom/new-chlamydia-test-delivers-results-about-30-minutes/
[G] May 2019 – Proprietary CT/NG test receives European CE Mark approval. https://mybinxhealth.com/news/binx-health-receives-ce-mark-for-rapid-chlamydia-and-gonorrhea-test-for-mass-markets/
[H] August 2019 – Following completion of successful multi-centre clinical trial for the dual CT/NG test, Binx Health received 510(k) clearance from the U.S. FDA to market the binx io platform to test and treat women for a dual CT/NG test. https://mybinxhealth.com/news/binx-health-receives-fda-510k-clearance-for-rapid-point-of-care-platform-for-womens-health/
[I] August 2019 - FDA 510k clearance for the binx io platform: https://www.fda.gov/medical-devices/510k-clearances/august-2019-510k-clearances
[J] Sep 2019 – First real-world use of the binx io platform, delivering same-visit diagnosis and treatment for chlamydia and gonorrhoea. https://mybinxhealth.com/news/binx-health-announces-first-patients-benefiting-from-single-visit-test-and-treatment-for-chlamydia-and-gonorrhea/
- Submitting institution
- The University of Bath
- Unit of assessment
- 8 - Chemistry
- Summary impact type
- Technological
- Is this case study continued from a case study submitted in 2014?
- No
1. Summary of the impact
With growing environmental concerns around the use of plastics there has been an increasing focus on the use of bio-based polymers. University of Bath research has developed catalytic approaches to support the production of green and sustainable polymeric materials. These have enabled the production of the bio-based thermopastic polymer polylactic acid (PLA) for use in commodity plastic products, through collaboration with industrial partner Total Corbion PLA (joint patents filed in 2014) underpinning industrial scale production (begun 2018) and commercialised sales. The impact includes construction of a 75,000 tonne capacity PLA manufacturing plant (2018), a USD100,000,000 investment that increased worldwide production of PLA by 50%, a volume representing market value of approximately USD150,000,000 per annum. The company has now announced its intention to build the first world-scale PLA plant in Europe.
2. Underpinning research
There is growing interest in bio-based and degradable plastics as a result of the negative impacts that traditional petroleum based plastics have on climate and health. Polylactic acid (PLA) is a bio-based biodegradable thermoplastic produced from renewable resources such as starch or sugar from corn or sugar cane, that offers an attractive plastic alternative. Development of catalysts for the manufacture of these bio-based plastics at scale is vital for a cost-effective and sustainable industrial process. However, very few sustainable initiators/catalysts are able to operate selectively to give high-value polymer in solvent-free conditions and at the high temperatures required for industrial production.
A 20 year programme of research within the Centre for Sustainable and Circular Technologies (CSCT) at University of Bath, led by Professor Davidson, has sought to develop such environmentally friendly homogeneous catalysts. Previous collaborative research with Johnson Matthey focused on the replacement of heavy metal catalysts in the manufacture of poly(ethylene terephthalate) (PET) and poly(urethane) (PU) [REF2014 Case Study]. Related benign Ti and Zr complexes were also found to be active catalysts for the ring-opening polymerisation (ROP) of cyclic esters such as ɛ-caprolactone and lactide with excellent levels of conversion and control [1,2,3].
To develop this concept towards PLA, new catalysts (with the embedded green benefit of avoiding heavy metals) had to be developed and optimised. Collaborative research between University of Bath and Total Corbion PLA (and predecessors Corbion and PURAC Biochem BV) has pursued this since 2010, addressing the need to identify catalysts that are highly selective in solvent-free environments and at high temperatures to enable industrial scale production of PLA; that replace traditional heavy metal-based catalysts; and that produce PLAs with defined and controlled physical and mechanical properties to broaden the scope of their application.
Initially this collaborative research showed that stereoselective ring-opening polymerisation (ROP) of racemic lactide ( rac-LA) under solvent-free conditions and supported by amine tris(phenolate) ligands offered an unprecedented combination of high stereocontrol (Pr > 0.90) and high activity (95% conversion in less than 30 minutes). This demonstrated for the first time that living and highly stereoselective ROP of rac-LA can be achieved in the bulk with high conversion on a timescale and at a temperature that are compatible with continuous processing technologies [4].
Subsequent research increased the activity and stability of the ROP catalysts, in contrast to commercially available group 4 metal alkoxides, this new group 4 catalyst was highly active in facilitating a more than 99% polymerisation to PLA within three hours, offering the potential of group 4 complexes as initiators for the commercial production of PLA [4].
This led to the development of a catalytic process for PLA production that was patented, based on Bath research and held by Total Corbion PLA (formerly Corbion, PURAC) [5, 6]. Using a new Group 4 metal PLA catalyst, mixing lactide and a metal-coordination compound (at least one of Zr and Hf) as polymerisation catalyst provided a benign tin-replacement catalysis process for PLA production at industrial scale [5, 6] and underpinned development of Total Corbion’s PLA production capability. This collaborative research continues; Dr Gerrit Gobius du Sart (Total Corbion PLA Chief Polymer Scientist) is a Visiting Industrial Fellow in CSCT.
3. References to the research
**
[1] Chmura, AJ, Davidson, MG, Jones, MD, Lunn, MD & Mahon, MF, 2006, 'Group 4 complexes of amine bis(phenolate)s and their application for the ring opening polymerisation of cyclic esters', Dalton Transactions, vol. 2006, no. 7, pp. 887-889. https://doi.org/10.1039/b513345a (with industrial co-authors, Johnson Matthey)
[2] Chmura, AJ, Davidson, MG, Jones, MD, Lunn, MD, Mahon, MF, Johnson, AF, Khunkamchoo, P, Roberts, SL & Wong, SSF, 2006, 'Group 4 complexes with aminebisphenolate ligands and their application for the ring opening polymerization of cyclic esters', Macromolecules, vol. 39, no. 21, pp. 7250-7257. https://doi.org/10.1021/ma061028j
[3] Chmura, AJ, Davidson, MG, Frankis, CJ, Jones, MD & Lunn, MD, 2008, 'Highly active and stereoselective zirconium and hafnium alkoxide initiators for solvent-free ring-opening polymerization of rac-lactide', Chemical Communications, vol. 2008, no. 11, pp. 1293-1295. https://doi.org/10.1039/b718678a
[4] Chuck, CJ, Davidson, MG, Gobius Du Sart, G, Ivanova-Mitseva, PK, Kociok-Kohn, G & Manton, LB, 2013, 'Synthesis and structural characterization of group 4 metal alkoxide complexes of N, N, N ′,N ′-tetrakis(2-hydroxyethyl)ethylenediamine and their use as initiators in the ring-opening polymerization (ROP) of rac -lactide under industrially relevant conditions', Inorganic Chemistry, vol. 52, no. 19, pp. 10804-10811. https://doi.org/10.1021/ic400667z Co-authored with Industrial Partner Corbion
[5] Patent (EPO): Method to manufacture PLA using a new polymerization catalyst, Filed May 2013, EP13166273A, Published as EP2799462A1, November 2014. Inventors Gerrit Gobius du Sart (PURAC Biochem BV), Matthew Davidson (University of Bath) and Christopher Chuck (University of Bath), Assignee is PURAC Biochem BV. https://worldwide.espacenet.com/patent/search/family/048193185/publication/EP2799462A1?q=pn%3DEP2799462A1%3F
[6] Patent (US): Method to manufacture PLA using a new polymerization catalyst, Filed April 2014, Published March 2016 US-20160075821-A1, Granted May 2018 US-9957350-B2. Inventors Gerrit Gobius du Sart (PURAC Biochem BV), Matthew Davidson (University of Bath), Christopher Chuck (University of Bath). Assignee is PURAC Biochem BV. https://patentimages.storage.googleapis.com/18/e7/db/c9c591b1e5a1ca/US9957350.pdf
Direct industrial / translation funding
Total of GBP954,000 including: Royal Society Industry Fellowship ( M G Davidson) 1999-2003 (GBP250,000); Industrial PDRA (ICI Synetix, now Johnson Matthey) 2002-2004 (GBP134,000);
EPSRC/TSB Link Project (with ICI Synetix, now Johnson Matthey) 2004-2007 (GBP200,000);
Knowledge Transfer Account Award and Industrial co-funding (with Purac, now Corbion Purac) 2010-2013 (GBP270,000)
4. Details of the impact
**
Polylactic acid (PLA) is a bio-based and biodegradable polymer that offers a more environmentally friendly alternative to traditional plastics with its reduced carbon footprint and manufacture from renewable resources. PLA is used in multiple industries including food packaging, oil and gas and automotive. Worldwide PLA had a estimated market worth of USD1,200,000,000 in 2018, with a calculated annual growth rate (CAGR) of 19.8% [A].
University of Bath research has directly informed the manufacturing processes of PLA and commercialisation activities of a multinational company, Total Corbion PLA. Specifically, the Bath research and generated IP [5, 6] led to:
Development of a catalytic process for the manufacture of PLA at industrial scale [5, 6] leading to establishment of an initial demonstrator plant and, in 2017, a 1,000 tonnes per annum pilot plant [B];
USD100,000,000 Investment into a new manufacturing plant, enhancing production capacity of PLA to 75,000 tonnes per annum (a growth world-wide of 50%) and operational in late 2018 [B];
Recent new investment in a manufacturing plant in Europe;
Reducing the environmental impacts of plastic.
This impact has been achieved using the Bath research insights into catalysts, collaborative research with industry partners, then through IP protection and full commercialisation [text removed for publication] [C].
Total Corbion PLA is a multinational based in the Netherlands, established in 2016 [D] by a joint venture between Total and Corbion PURAC, and evolved from PURAC Biochem BV. They have become a global leader in the marketing, sales and production of polylactide [E, F].
Implementing the catalytic process for the manufacture of PLA at industrial scale
In 2013, the developed method for manufacturing PLA [5] was implemented in small scale technology. This successful Corbion demonstrator, together with the evident high growth of the market for PLA, led to the construction of a 1000 tonnes per annum pilot and product development plant (announced 2014, operational December 2017), a 75,000 tonnes per annum manufacturing scale plant (operational 2018) and the announcement in 2020 of a new 100,000 tonnes per annum plant in France (scheduled to be operational in 2024).
USD100,000,000 Investment into a new manufacturing plant to enhance production capacity
The manufacturing scale plant was funded through a Joint Venture company (established November 2016), more than USD100,000,000 investment offering a completely new business opportunity for Total Corbion PLA [E, F]. This plant came online (in 2018, in Rayong, Thailand); its 75,000 tonnes per annum capacity represents an approximately 50% increase of world capacity for production of the important sustainable polymer PLA [G], with a projected market value of approximately USD150,000,000 per annum. The plant produces a wide range of Luminy® PLA resins, products that serve the needs of a global customer base, in 2019 over 350 customers worldwide and in a wide range of markets, including packaging, 3D printing and automotive sectors [H]. In addition, and adding commercial value for the established plant, it is co-located with integrated 100,000 tonnes per annum lactide manufacturing capability, and with the 1000 tonnes per annum pilot plant used for new product development [B]. This adds to the Total Corbion PLA materials portfolio, based on a fully integrated production chain from green feedstock to PLA [G].
In 2020, Corbion and Total announced their intention to build a further 100,000 tonnes per annum capacity PLA manufacturing plant through the Total Corbion PLA joint venture. This will add to the Thailand plant and will be the first world-scale PLA production facility in Europe [H]. This will make the company the world’s number 1 producer of PLA.
Reducing the environmental impacts of plastic
Total Corbion PLA have carried out life cycle assessment of the environmental effect of plastics and the consequent benefits of PLA adoption [G, I]. This analysis shows that from the cradle-to-gate perspective, considering the uptake of carbon dioxide in the PLA molecule, the global warming potential (GWP) is only 501kg CO2 equivalent per tonne PLA [I, J]. The Luminy® PLA produced by Total Corbion PLA are thus estimated to provide a 75% reduction in carbon footprint compared to most traditional fossil-based plastics; this arises from both the green feedstocks used in the manufacturing process and the biodegradeable nature of PLA polymer.
“From a cradle-to-gate perspective the Global Warming Potential (GWP) of PLA is confirmed to be only 500g CO2 per kg of PLA" says the Senior Marketing Director at Total Corbion PLA, " which is roughly a 75% reduction in carbon footprint versus most traditional plastics" [J].
5. Sources to corroborate the impact
**
[A] Grand View Research Inc., Market Research report, October 2020. https://www.grandviewresearch.com/industry-analysis/polylactic-acid-pla-market
[B] Corbion Annual Report 2018. https://annualreport.corbion.com/FbContent.ashx/pub_1000/downloads/v200312101738/Corbion_AR2018.pdf (pp.21, 69-70)
[C] [text removed for publication]
[D] Corbion Press Release 2016: Total and Corbion form a Joint Venture in bioplastics 2016 http://www.corbion.com/media/press-releases?newsId=1026123
[E] Article, Business Focus magazine, March 2020. https://www.businessfocusmagazine.com/2020/03/31/total-corbion-pla-a-new-kind-of-plastic/
[F] Total Corbion Website. https://www.total-corbion.com
[G] Corbion Annual Report 2019. https://annualreport.corbion.com/FbContent.ashx/pub_1000/downloads/v200415100131/Corbion_annual_report_2019.pdf (p. 23)
[H] Article, Agro & Chemistry magazine, Netherlands, September 2020. https://www.agro-chemistry.com/news/corbion-and-total-to-build-first-world-scale-pla-plant-in-europe/
[I] Morão, A. & de Bie, F. (2019) Life Cycle Impact Assessment of PLA Produced from Sugarcane in Thailand. Journal of Polymers and the Environment volume 27, (pp2523–2539) https://link.springer.com/article/10.1007/s10924-019-01525-9
[J] Article, Packaging Europe magazine, October 2019. https://packagingeurope.com/low-carbon-footprint-of-pla-confirmed-by-peer-reviewed-life-/
- Submitting institution
- The University of Bath
- Unit of assessment
- 8 - Chemistry
- Summary impact type
- Environmental
- Is this case study continued from a case study submitted in 2014?
- No
1. Summary of the impact
Current public health monitoring systems cannot provide real time and comprehensive information on community health. Wastewater based epidemiology (WBE) offers a solution, providing real-time long-term spatiotemporal datasets on public and environmental health and risks. Using University of Bath research in environmental analytical chemistry, a novel diagnostic approach, urban water fingerprinting, has been established to conduct WBE, impacting health, wellbeing and the environment:
Adoption of WBE by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in 2016 to estimate spatiotemporal trends of illicit drug usage; this feeds into their Europe-wide evidence based early warning system;
Adoption of a WBE-based Water fingerprinting platform by Wessex Water (WW), major water supplier with 2,800,000 customers, changing their operations to mitigate environmental health impact, including a GBP1,000,000 investment by WW to monitor public and environmental health risks including SARS-CoV-2 surveillance.
2. Underpinning research
Rapid assessment of public and environmental health is essential for the prevention, control or mitigation of exposure risks as well as improving our population’s health. This includes exposure to chemicals (e.g. illicit drug usage and industrial chemical exposure) and biological risks (e.g. pathogens such as SARS-CoV-2). Current epidemiology approaches (such as molecular epidemiology) are limited in scope due to logistical difficulties and high cost, the restricted size of study groups and inability to gather comprehensive information on combined spatiotemporal exposure to mixtures of stressors and their effects. Therefore, the community lacks robust measures to gather real-time information on community-wide exposure and resulting disease.
There is a need for an evidence-based public health risk prediction system, to collate long-term spatiotemporal datasets on public health status and trigger rapid response from regulatory and public health sectors that can prevent disease and promote environmental health. Such a system can allow public health threats to be identified rapidly, at low cost, and instantly dealt with, reducing the global burden on public health. Professor Kasprzyk-Hordern’s research at University of Bath in environmental and analytical chemistry has made major contributions to the development of a new diagnostic technology, urban water fingerprinting, to conduct wastewater-based epidemiology (WBE), providing a revolutionary solution that has gained wide adoption.
Urban water fingerprinting, a cutting edge approach of extracting epidemiological information, has been developed as a key part of WBE, to provide anonymised, comprehensive and objective information on the health status of populations and surrounding environments in real time. WBE was developed in a strong cross-sectoral and transdisciplinary collaborative research initiative within the Sewage Analysis CORe group Europe (SCORE), and EU SEWPROF project (2012-16) which was led by Professor Kasprzyk-Hordern.
Since 2010, Professor Kasprzyk-Hordern has made key research contributions to the development of WBE and water fingerprinting via:
Development of bioanalytical methods followed by comprehensive research on the fate and effects of emerging contaminants in the UK environment (especially South West) (1), yielding one of the most comprehensive aqueous environment profiling studies in the UK (2).
Development of new fingerprinting approaches including a new tool for WBE biomarker discovery (3) utilising high resolution mass spectrometry, suspect screening and retrospective data analysis (4) as well as human biomonitoring (in-vitro HLM/S9 fraction assays and in-vivo human metabolism). This represents the first chemical exposure analysis to some key chemicals such as bisphenol A using WBE.
Demonstrating that WBE, including enantiomeric profiling of water utilising mass spectrometry and chiral separations in the context of illicit drug speciation, can provide information on abuse trends (3, 5). This represents the first report using enantiomeric profiling of chiral drugs of abuse in WBE, which can provide information on abuse trends and potency of chiral drugs used. This research fed directly into WBE methodology Europe-wide through SCORE (6), the first Europe-wide study of illicit drug use through sewage biomarker analysis using WBE. The Bath-developed analytical research methods were applied alongside other methods developed by the SCORE group, to compare illicit drug use across 19 European Countries (6).
This research has been conducted in a strong cross-sectoral and transdisciplinary collaborative ethos within the projects EU SEWPROF (2012-16), EU SCORE, international GCRF projects ReNEW (2017-20), EDGE (2020-21) and EWS-C19 (2020-21), as well as through Leverhulme, UK Research Council funding and national UKRI N-WESP (2020-21).
3. References to the research
Petrie, B, Youdan, J, Barden, R & Kasprzyk-Hordern, B 2016, 'Multi-residue analysis of 90 emerging contaminants in liquid and solid environmental matrices by ultra-high-performance liquid chromatography tandem mass spectrometry', Journal of Chromatography A, vol. 1431, pp. 64-78. https://doi.org/10.1016/j.chroma.2015.12.036
Proctor, K, Petrie, B, Lopardo, L, Muñoz, DC, Rice, J, Barden, R, Arnot, T & Kasprzyk-Hordern, B 2021, 'Micropollutant fluxes in urban environment – A catchment perspective', Journal of Hazardous Materials, vol. 401, 123745. https://doi.org/10.1016/j.jhazmat.2020.123745
Lopardo, L, Cummins, A, Rydevik, A & Kasprzyk-Hordern, B 2017, 'New Analytical Framework for Verification of Biomarkers of Exposure to Chemicals Combining Human Biomonitoring and Water Fingerprinting', Analytical Chemistry, vol. 89, no. 13, pp. 7232-7239. https://doi.org/10.1021/acs.analchem.7b01527
Lopardo, L, Petrie, B, Proctor, K, Youdan, J, Barden, R & Kasprzyk-Hordern, B 2019, 'Estimation of community-wide exposure to bisphenol A via water fingerprinting', Environment International, vol. 125, pp. 1-8. https://doi.org/10.1016/j.envint.2018.12.048
Kasprzyk-Hordern, B & Baker, DR 2012, 'Estimation of community-wide drugs use via stereoselective profiling of sewage', Science of the Total Environment, vol. 423, pp. 142-150. https://doi.org/10.1016/j.scitotenv.2012.02.019
Thomas, KV, Bijlsma, L, Castiglioni, S, Covaci, A, Emke, E, Grabic, R, Hernández, F, Karolak, S, Kasprzyk-Hordern, B, Lindberg, RH, Lopez de Alda, M, Meierjohann, A, Ort, C, Pico, Y, Quintana, JB, Reid, M, Rieckermann, J, Terzic, S, van Nuijs, ALN & de Voogt, P 2012, 'Comparing illicit drug use in 19 European cities through sewage analysis', Science of the Total Environment, vol. 432, pp. 432-439. https://doi.org/10.1016/j.scitotenv.2012.06.069
4. Details of the impact
Development, adaptation and implementation of a new diagnostic technology (water fingerprinting by WBE) for estimation of illicit drug usage at a community level across Europe.
Wastewater-based epidemiology (WBE) offers an evidence-based public health risk prediction system that can help prevent disease and promote environmental health across the globe. The EU funded SCORE group and SEWPROF project developed a wastewater-based epidemiology tool using urban water-fingerprinting, including University of Bath developed research methods for enantiomeric profiling, data analysis and sampling approaches ( 5, 6). This WBE tool was adopted and implemented by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in 2016. The EMCDDA provides the EU and its Member States with a factual overview of European drug problems and a solid evidence base to support the drugs debate and offers policymakers the data to inform drug laws and strategies. It also supports professionals and practitioners working in the field. Since 2016, SCORE’s WBE data has fed directly into the Europe-wide evidence based early warning system: “Wastewater analysis has now demonstrated its potential as a complement to established monitoring tools and has moved from being an experimental technique to being a new method in the epidemiological toolkit” [A; EMCDDA European Drug Report 2016].
Since 2016, SCORE’s WBE data has been included in the annual EMCDDA Drugs reports via addition of city-level information from European research networks, which complements national data in the areas of wastewater analysis and drug-related hospital emergencies and enriches understanding of both drug consumption patterns and harms across Europe [A, B]. The approach is acknowledged as a key game changer in this area:
“The problem of measuring drug use, a complex, hidden and often highly stigmatised behaviour, is a central component of the work carried out by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). (...) [SCORE research], based on the analysis of municipal wastewater for drugs and drug residues, provides us with the opportunity to obtain more timely information on geographical and temporal drug use patterns (…) its ability to deliver near-real-time data is particularly relevant to the mercurial nature of today’s drug problem (…) wastewater analysis can help health and treatment services in a number of ways” [C; Director of EMCDDA].
WBE is also being applied in a wider range of contexts. The concept of WBE is being implemented by DEFRA as an evidence-based tool for monitoring SARS-CoV-2 prevalence in coronavirus pandemics, feeding into the Joint Biosecurity Centre [D, E; group includes Bath], while Professor Kasprzyk-Hordern has also co-authored a US-CDC/Wellcome/UK Science & Innovation Network White Paper on Addressing Antimicrobial Resistance in the Environment [F]. This emphasises the broader applicability and transferability of the developed methodologies.
Development of policy and practice on environmental health with Wessex Water.
Since 2010, Professor Kasprzyk-Hordern’s research on water fingerprinting and comprehensive spatiotemporal profiling of pollution in the Avon Catchment ( 1, 2, 3, 4) has led to significant impact on a key project partner and research collaborator, Wessex Water (WW), a major regional public water utility company serving a population of 2,800,000. This research has shaped the strategic direction of WW, shifting their focus to WBE to look at the wider impact on public health, environment and ecosystem, informed investment decisions and improved their ability to detect and analyse a wider range of compounds and their metabolites using new rapid analytical techniques.
Specifically, the Bath research has been an essential resource for the long term planning of technologies at sewage treatment works by WW, to respond to changing environmental standards and contaminants of emerging concern [G]. Importantly, the impact goes beyond the technical aspects, reaching into mitigating social inequality and enhancing regional collaborative working.
The Director of Environmental Strategy at Wessex Water states the direct benefits to WW from the collaborative research with the Bath group [G]; these include:
“Improved Wessex Water’s ability to detect and analyse a wider range of compounds and their metabolites using new rapid analytical techniques; improved sampling methods and influenced sampling sites;
Informed Wessex Water priorities including investment decisions and future areas of work, i.e. Social Prescribing and reducing medicines waste (GBP1,000,000 investment), UKWIR AMR [Anitmicrobial resistance] programme (the choice of site and methods); NERC FRESH project (incorporating methods for evaluating new technologies). These research areas have been incorporated into our PR19 Business Plan (2020 to 25) which was approved by Ofwat and the Secretary of State in December 2019;
Contributed to Wessex Water shift in focus from characterising wastewater to looking at the wider impact on the environment, ecosystem and public health;
Enhanced local / regional collaborative working […] the social prescribing work can contribute towards the green recovery and address social inequality which has been revealed through the Covid-19 crisis;
Raised awareness and understanding of the wider impact of contaminants in our sewage and receiving watercourses” [G].
5. Sources to corroborate the impact
[A] European Drug Reports 2016 - 2020, published by EMCDDA.
https://www.emcdda.europa.eu/publications-database?search_api_views_fulltext=european+drug+report
[B] EMCDDA Wastewater-based epidemiology and drugs topic page. http://www.emcdda.europa.eu/wastewater-analysis
[C] European Monitoring Centre for Drugs and Drug Addition (2016) ‘Assessing illicit drugs in wastewater, Advanced in wastewater based epidemiology’, Insights 22, Publications Office of the European Union, Luxemburg; PDF file from:
http://www.emcdda.europa.eu/publications/insights/assessing\-drugs\-in\-wastewater\_en
[D] DEFRA Announcement, “Group to measure for coronavirus prevalence in waste water”, June 2020.
https://www.gov.uk/government/news/group-to-measure-for-coronavirus-prevalence-in-waste-water
[E] UK Government Press Release, “Sewage signals early warning of coronavirus outbreaks”, October 2020.
https://www.gov.uk/government/news/sewage-signals-early-warning-of-coronavirus-outbreaks
[F] Initiatives for Addressing Antimicrobial Resistance in the Environment; US-CDCX/Wellcome/UK Science & Innovation Network White Paper. https://wellcome.org/sites/default/files/antimicrobial-resistance-environment-report.pdf
(pp. 31-45)
[G] Wessex Water: letter from Director of Environmental Strategy, 7 September 2020.