ETERNAL's recent final official project dissemination event provided project partners and external guests alike an opportunity to reflect upon and celebrate notable progress made during four years of collaborative research and scale-up for sustainable development of pharmaceutical manufacture, use and disposal, along with notable contributions towards building the the EU’s knowledge base informing environmental risk and ecotoxicity assessemts of pharamceuticals on the one hand and policy development on the other.
The meeting took place the heart of central Manchester, UK, during a very eventful week for the increasingly prominent city which has over the last ten years or so become emblematic of a renewed dynamism in the North of England, which as one of the major cradles of original industrial revolution, has sought to redefine its role in the national and global economies of the 21st Century. So whilst it was of course just coincidence, it was nevertheless a noteworthy coincidence that the man at the heart of much of that renewed vision, former Mayor of Greater Manchester, Andy Burnham, was making the short journey down the Mall in London to be appointed Prime Minister of Great Britain by King Charles at Buckingham Palace.
Reflecting the sense of innovation and changes to ways of working in the air (one of Prime Minister Burnham’s first surprise announcements being the establishment of a “No 10 of the North” as a step forward in devolving the UK’s approach to goverment from Westminster) ETERNAL’s programme for the day provided a packed series of presentations, an extensive poster and display area and scope for audience interaction and networking geared towards highlighting not just substantial technical advances across a range of six complementary green chemistry / sustainability focused industrial case studies, but also new scientific insight to inform regulatory and policy development approaches across the EU, and contributions to models for behavioural change across the pharmaceutical development, manufacture, use and disposal lifecycle.
After Project Coordinator Pablo Ferrer Pérez, from AIMPLAS (Spain’s Plastics Technology Centre) called the meeting to order with some opening words of welcome, delegates were able to hear a recorded message of greeting from Martin Uriarte Asteinza, Policy Officer at the European Commission, DG Research and Innovation, who oversees the EU’s Research and Innovation policies on environmentally sustainable Health and Care. Dr Uriarte congratulated ETERNAL on its “remarkable work and results”, going on to say that that ETERNAL has contributed solidly to the advancement of green pharmaceuticals manufacturing. green digital methods, our understanding of ecotoxicity, and the safer use and disposal of drugs. Reflecting on how the broader EU policy context and framework (from the European Green Deal’s committment to a climate neutral Europe by 2050, key regulatory reforms for EU Pharmaceuticals, the Urban Waste water Directive, REACH, and the Chemical Strategy for Sustainability) set up the regulatory guidelines for greener practice in Pharma, Dr Uriarte also emphasised the relevance of the broader political “push” for sustainable competitiveness in Europe to ensure a thriving and sustainable health and Care sector. This depends to a large extent on our collective capacity to innovate. Research and Innovation must be leveraged to ensure maintenance of economic strength and resilience for long-term sustainability across all key EU sectors of economic activity.
In this respect, he described the Pharmaceutical sector as “an economic and social powerhouse for Europe, driving wealth, creating jobs, and providing breakthrough innovations.” And yet, this does not come wihout its enviromental challenges. Pharmaceutical manufacture makes a large contribution to the “vast” carbon footprint of the health sector in general. In addition the sector is a source of harmful emissions and compounds which when released into the environment threaten human health and ecosystems. These pround challenges however also present opportunities: to lead in greener technologies, and also to strengthen competitiveness while enhancing the environmental sustainability fo the industry. Within this context projects like ETERNAL and its sister Green Pharma cluster projects are critical in helping the EU seize these opportunities.
Whilst “delighted” to see ETERNAL and its sister projects reaching their conclusion and delivering on their promises to make pharmaceutical manufacturing safer and more sustainable, this is not the end of the road. To move from cutting edge ideas to widespread reality requires us to overcome further challnges: regulatory hurdles, questions around economic viability, and information gaps amongst others. In commending ETERNAL’s researchers, Dr Uriarte also encouraged them to share their results as new projects come online to “pick up the baton” and called for close collaboration across the whole spectrum of stakeholders need to ensure success.
Across the rest of the day, it was evident that ETERNAL’s research partners, industrial end users, innovative SMEs and and providers of specialist expertise in everything from ecotoxicity and environmental risk analysis, digitalisation, early-stage risk-based decision making for sustainable innovation, policy briefing, standarization, IP protection and exploitation planning, provision of open and “FAIR” data, had approached their work with a very similar accord: working flexibly, creatively and synergistically with other partners, across tasks, work packages, and even projects thorugh the Green Pharma cluster, and with final, shareable results in hand, increasingly looking to maximise their impact beyond the limits of a single consortium and a point in time.
With ETERNAL built around the scale-up of six industrial case studies (in point of fact several of the “six” sensibly resolved further into two or more applications of focal point enabling technologies within the overall case study) there was no shortage of tangible, demonstrable industry-relevant innovation for business stakeholders to engage with. The case studies, co-ordinated collectively for the project by whole-process understanding specialists Britest but hosted and led by an industrial end user , comprised continuous downstream manufacturing with associated reduction in energy consumption; better use of solvents including recycled and greener alternatives (both led by Angelini Pharma); reduction or elimination of solvents through advanced formulation approaches (Laboratorio Reig Jofre); methodological development for new continuous Greener-By-Design synthesis methods (Arcinova); greener continuous synthesis avoiding toxic side products (MyBiotech); and solvent purification through Organic Solvent Nanofiltration (AstraZeneca). Further details of many of these case studies and associated work around them may be found in a series of accessible two-page case study summaries prepared during the second half of the project.
These success stories are themselves however only part of the picture however. The meeting also heard from Digitalisation expert lead partner IRIS how digital approaches were a key enabler for success in several of the case studies. These were applied to a wide range of duties straddling everything from building Digital Twins of envisaged case study processes to reduce real-world DoE time, material and cost burdens, combining PAT (Process Analytical Technology) + ML (Machine Learning) into a platform for enabling real-time monitoring successfully applied to selected case studies, and introducing a digital workflow for transfer of process descriptive documentation between organizations, again with massive potential to save time and human error. Further advances enabled through digitalisation included the realisation of a enhanced Raman spectroscopy based inline detection method critical to the success of MyBiotech’s continuous downstream processing case studying, and fresh thinking about the form of environmental optimisation factor to use to target in-silico rapid continouus process automation in the case of Arcinova.
Beyond these extended technical fontiers, ETERNAL has also strongly contributed to knowledge building for better policy and regulation by identifying opportunities for further improvement in the EC’s proposed ERA-based protections, through new spatio-temporal visualisations supporting risk prioritisation in European waters and soils associated with pharmaceutical actives and associated compounds, and extensive published research into Ecotoxicity effects and Bioremediation strategies for safer by design pharmaceuticals. In trun, this work has been fundamental in enabling ETERNAL to play a full part in conveying scientific evidence into a new policy brief for greener, safer medicines as part of the Green Pharma projects cluster which is now available to all interested parties.
Through the capable guidance of the Spanish Association for Standardisation UNE, has helped drive innovation in standardizing ways of working, notably through the development of two CEN Workshop Agreements (CWAs) for Early-Stage Sustainability Assessment and Efficient Energy by Design and Determination of nucleic acid encapsulation efficiency in Lipid Nanoparticles using fluorometry. CWAs are form of fast-track, open-consensus reference document created by the European Committee for Standardization (CEN) to meet immediate market needs.
The project has delivered upon a concerted exploitation strategy, fully developing identified key exploitable results iteratively into bespoke business models providing clearly defined exploitation pathways for each partner / result as applicable. New formal intellectual properties rights are being created through a patent application by IRIS for AI Driven Calibration of Spectral Data in a Modular Raman Spectrograph, and a new trademark being processed in Ireland/UK by Enviroeye.
In summary, ETERNAL’s portfolio brings together diverse complementary Key Exploitable Results covering the entire pharmaceutical manufacturing value chain from upstream bioprocess optimisation to advanced formulation, continuous manufacturing, digitalisation and decision-support methodologies.
Get in touch and stay in touch! Links to individual ETERNAL partners are available on this website and the overall project co-ordinators at AIMPLAS will be dleighted to help steer any enquiries you make have about the project and future developments.
You may also wish to browse the contents of the poster display presented as part ETERNAL’s Final Dissemination Event (pdfs available to download) and our range of peer-reviewed publications, public delieverables and miscellaneous resources.
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