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Real-Time LCA: From Sustainability Reporting to Sustainable Action
From Impossible to Circular: Unlocking Recycling Pathways for Pharmaceutical Packaging
Just Breathe! Sustainable initiatives beyond the Green Transition
Insects’ Protein in Animal Nutrition: The Regulatory Landscape in the EU and US
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Empowering pharma and biotech with circular and ecodesigned solutions. Since 2021, every new product has been designed according to ecodesign principles within ISO 14001, ensuring sustainability is integrated from concept to commercialization. Circular economy thinking is embedded in product development, with a focus on recyclability and device take-back solutions that minimize environmental impact. Our global supply chain adheres to strict ethical, human rights, and environmental standards, enabling responsible sourcing and manufacturing at every stage.
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CONTENTS 04 FOREWORD GREEN INDUSTRY GROWTH 06 How Collaboration Can Turn Pharma’s Sustainability Ambitions Into Action Silvia Forroova representing CPHI Milan explores opportunities to reduce emissions, improve supply chains, advance green chemistry and packaging, and build resilience through shared standards, innovation and long-term partnerships. 09 Carbon Footprints: Ypsomed’s Path to More Sustainable Selfcare Ypsomed’s Sabine Huber and Thuysi Dao explore how ecodesign, sustainable materials, circularity and energy efficiency can reduce the environmental footprint of self-injection devices. The article highlights the importance of lifecycle thinking and collaboration across the value chain. MANAGING DIRECTOR Mark A. Barker
14 Real-Time LCA: From Sustainability Reporting to Sustainable Action
BUSINESS DEVELOPMENT Anthony Stewart anthony@senglobalcoms.com
Real-time life cycle assessment can transform sustainability data from static reporting into actionable insight. Serena Grace and Marina Dumont of Owen Mumford examine how integrated data, dynamic LCA models and user-friendly tools can help pharmaceutical organisations respond more effectively to evolving sustainability requirements.
Mark A. Barker mark@senglobalcoms.com EDITORIAL MANAGER Alice Phillips alice@senglobalcoms.com DESIGNER Jana Sukenikova www.fanahshapeless.com EDITORIAL ASSISTANT Carla Devine carla@senglobalcoms.com
18 From Impossible to Circular: Unlocking Recycling Pathways for Pharmaceutical Packaging Nextek’s Edward Kosior explores how advanced recycling technologies, Extended Producer Responsibility and collaborative initiatives could create scalable pathways for pharmaceutical packaging circularity while maintaining safety, compliance and performance. 21
The Limits and Opportunities of Plastics for Recycling
ADMINISTRATOR Barbara Lasco
Luca Chiochia of ELIX Polymers examines the limitations of mechanical recycling and the emerging opportunities offered by chemical recycling and bio-based feedstocks, particularly for demanding medical applications.
FRONT COVER istockphoto
24 Just Breathe! Sustainable Initiatives Beyond the Green Transition
PUBLISHED BY Senglobal Ltd. 20–30 Whitechapel Road, London, E1 1EW United Kingdom Tel: +44 (0) 2045417569 Email: info@senglobalcoms.com www.pharmanaturepositive.com
Moving beyond the transition to low-GWP propellants, Bespak’s explores how smarter engineering, waste reduction, biodiversity and supply-chain decarbonisation can further reduce the environmental impact of pMDIs. 27 The Sustainability Challenge in Advanced Therapy Manufacturing Jill Makin of Touchlight examines how enzymatic, cell-free DNA production could reduce water, energy, waste and production times, while improving efficiency across gene therapy and other advanced therapy manufacturing processes.
Pharma Nature Positive is published Annual by Senglobal Ltd. The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or the Publisher. Please note that although care is taken in the preparation of this publication, the Editor and the Publisher are not responsible for opinions, views, and inaccuracies in the articles. Great care is taken concerning artwork supplied, but the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright. Volume 5 Issue 1 2026 Senglobal Ltd.
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30 Insects’ Protein in Animal Nutrition: The Regulatory Landscape in the EU and US Insect protein is gaining momentum as a sustainable alternative for animal nutrition, but regulation remains complex. Argenta’s Daniel Pagés compares the evolving EU and US frameworks, covering authorised species, feed substrates, safety requirements and emerging approval pathways. 33 Breathing New Life into pMDIs: Pharma’s Sustainability Drive This article by Andy Burns of Kindeva examines how pharmaceutical companies can navigate the transition, and how specialist CDMO expertise, infrastructure and integrated development can help bring more sustainable pMDIs to patients without compromising safety or performance.
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A COMPLIANCE GUIDE Pharmaceutical Sustainability in 2026: A Compliance Guide
Discover how pharmaceutical sustainability is transforming compliance in 2026. Explore key frameworks and strategies for a greener future. Pharmaceutical sustainability is defined as the strategic integration of environmentally responsible manufacturing, regulatory compliance, and green innovation across the entire life cycle of medicinal products. The field has shifted decisively from voluntary corporate social responsibility to a regulated discipline with measurable performance requirements. Key frameworks now shaping the industry include Environmental Risk Assessments mandated by the UK MHRA, Extended Producer Responsibility obligations under EU Directive 2024/3019, and lifecycle-based indices like AstraZeneca’s Product Sustainability Index. Understanding how these frameworks connect is no longer optional for pharmaceutical professionals. It is a compliance requirement with financial consequences. What is pharmaceutical sustainability and why does it matter in 2026? Pharmaceutical sustainability has evolved from a peripheral CSR task into a core regulatory and operational discipline, centred on lifecycle assessments, green chemistry, and measurable environmental performance. This shift is driven by converging regulatory pressure from the UK MHRA, the European Medicines Agency, and the European Commission, all of which now require documented environmental analysis as part of product authorization and postmarket management. The impact of pharmaceuticals on the environment is well documented. Active pharmaceutical ingredients (APIs) discharged into waterways disrupt aquatic ecosystems, and manufacturing processes generate significant greenhouse gas emissions, solvent waste, and water consumption. Scope 3 emissions, which include outsourced API synthesis and raw material extraction, dominate the carbon footprints of most major pharmaceutical companies. The business case is equally clear. Companies that embed sustainability data into product decisions reduce regulatory rework, manage EPR fee exposure, and attract ESG-conscious investors and partners. Sustainability is a risk management tool, not an ideological exercise. What is an Environmental Risk Assessment and why is it central to compliance? An Environmental Risk Assessment (ERA) is a structured evaluation of the risks a pharmaceutical substance poses to the environment, covering physicochemical properties, ecotoxicological data, and environmental fate. As of April 2026, UK marketing authorization applications require a complete ERA, with specific mitigation measures documented in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) where risks are identified. The MHRA’s ERA framework aligns with EMA’s 2024 guideline EMEA/ CHMP/SWP/4447/00 Rev. 1, which requires predicted environmental concentration assessments based on UK-specific prevalence data. EU prevalence data is acceptable only when it produces a more conservative estimate than UK data. This distinction matters operationally: teams that default to EU datasets without verification risk submitting non-compliant ERAs. A compliant ERA evaluates risk across three domains:
• • •
Physicochemical properties: Water solubility, octanol-water partition coefficient, and vapor pressure inform exposure modelling. Ecotoxicological data: Acute and chronic toxicity to aquatic organisms, including fish, invertebrates, and algae. Environmental fate: Biodegradability, soil adsorption, and bioaccumulation potential determine persistence and spread.
Where risks are identified, the ERA must propose mitigation measures. These may include disposal guidance, packaging restrictions, or
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manufacturing process changes. The ERA is not a one-time submission. Post-approval changes that affect environmental exposure require ERA updates, making it a living document within the product lifecycle. Pro Tip: Validate exposure data quality and prevalence assumptions early in development. The most common ERA pitfall is underestimating data quality requirements, which leads to regulatory rework and submission delays. How do EU wastewater directives impact pharma manufacturers? EU Directive 2024/3019, the revised Urban Wastewater Treatment Directive (UWWTD), introduces a structural shift in how pharmaceutical companies bear responsibility for environmental contamination. The directive mandates quaternary treatment at wastewater plants to remove micropollutants, with a minimum 80% removal efficiency required. It also introduces mandatory monitoring for PFAS and microplastics at plants serving populations above 10,000 person equivalents. The most consequential element for pharmaceutical manufacturers is the Extended Producer Responsibility (EPR) scheme. Under this mechanism, pharma producers from end 2028 must collectively cover 80% of the costs of quaternary treatment and micropollutant monitoring. The remaining 20% is covered by cosmetics producers. This is not a voluntary contribution. It is a legally binding financial obligation tied directly to product portfolios. What frameworks are industry leaders using to operationalise sustainability? The most instructive example of operationalized pharmaceutical sustainability comes from AstraZeneca. The company’s Product Sustainability Index (PSI) is a multi-category scoring tool built on ISO 14040/14044 lifecycle assessment standards. By 2025, AstraZeneca had assessed 79% of its launched products by sales revenue using the PSI. That figure represents a genuine commitment to data-driven decision-making, not a headline metric. The PSI scores products across five categories: greenhouse gas emissions, water use, API discharge risks, raw materials sourcing, and innovation. Each category generates an improvement plan, creating what sustainability practitioners call a metrics-to-decisions feedback loop. LCA outputs translate directly into product-level priorities, which then inform R&D, procurement, and manufacturing decisions. This is the architecture that makes sustainability operationally real rather than aspirationally stated. Green chemistry is the manufacturing-side complement to lifecycle thinking. Process Mass Intensity (PMI) and solvent burden are the primary benchmarks for evaluating manufacturing routes. Solvents typically dominate PMI, making solvent substitution the highestleverage intervention in green API manufacturing. A concrete example: deep eutectic solvents for lidocaine synthesis, using a menthol and decanoic acid eutectic mixture for liquidliquid extraction, achieved a 92% isolated yield while eliminating conventional organic solvents. This approach, assessed using standard green chemistry metrics, demonstrates that solvent reduction does not require sacrificing yield or scalability. Key Takeaways Pharmaceutical sustainability in 2026 requires integrating ERA compliance, EPR financial planning, lifecycle assessment, and Scope 3 supply chain management into a single, metrics-driven operational framework.
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Make the next transition feel seamless The transition to next-generation propellants raises the bar for sustainability, while demanding proven performance and dependable commercial supply. Kindeva supports the seamless transition to next-generation propellants, helping ensure tomorrow’s MDIs match the performance of today’s inhalers.
See how Kindeva supports your MDI
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FOREWORD In 2026, sustainability across the pharmaceutical industry is moving from ambition to implementation. The focus is increasingly on how environmental considerations can be embedded into the decisions that shape the development, manufacture and delivery of medicines, alongside quality, cost, compliance, resilience and patient outcomes. This issue of Pharma Nature Positive explores some of the practical developments driving that change. Across manufacturing, packaging, supply chains and drug delivery, organisations are looking beyond individual initiatives towards more integrated approaches that reduce emissions, improve resource efficiency and support circularity.
As the industry comes together at CPHI Milan, including at the CPHI Sustainability Summit, these conversations will become increasingly important. The opportunity is to share practical experience, challenge established approaches and build the partnerships needed to accelerate change. We hope this issue of Pharma Nature Positive gives you a useful snapshot of where the industry is heading, while offering practical examples and ideas that can help inform the sustainability journey ahead. From product design and advanced manufacturing to collaboration across the value chain, the articles in this edition highlight the different ways progress is taking shape. I hope you enjoy the journal and find plenty of insight to take forward.
Alice Phillips, Editorial Manager, Senglobal Ltd
We begin this issue with a piece from the Director of Partnerships & Sustainability at CPHI, Silvia Forroova, exploring how the industry can move from sustainability commitments to practical action through stronger partnerships across the pharmaceutical value chain. From Scope 3 emissions and supplier engagement to green chemistry and sustainable packaging, the article highlights the importance of shared solutions, transparency and long-term collaboration in tackling challenges that no single organisation can address alone. For drug delivery, the Ypsomed article offers a valuable look at what sustainability can mean at the product-design stage. It explores how ecodesign principles, bio-based materials, reduced material use and design for disassembly can lower environmental impact without compromising the safety, usability or performance expected of self-injection devices. It also demonstrates why looking beyond the manufacturing site to Scope 3 emissions, suppliers and end-of-life systems is becoming essential. For anyone considering how sustainability can be translated into practical engineering decisions, it provides a useful example of how lifecycle thinking can influence a product from its earliest stages. The Touchlight article looks at a very different challenge: the sustainability of manufacturing the advanced therapies themselves. As gene therapies, mRNA medicines and other genetic medicines move towards larger-scale production, resource-intensive manufacturing processes could become a significant constraint. The article examines the environmental burden associated with traditional plasmid DNA production and explores enzymatic, cell-free DNA manufacturing as an alternative. Its relevance extends beyond DNA production, showing how changing an upstream process could reduce water, energy and material use while improving efficiency further downstream. It offers an insight into why sustainability and scalability increasingly need to be considered together when developing the next generation of medicines. Together, these articles demonstrate that pharmaceutical sustainability is no longer confined to energy consumption or carbon targets. It is increasingly influencing how products are designed, how manufacturing processes are developed and how companies work with partners across the value chain. The common theme is the need to move from individual initiatives towards solutions that can deliver measurable impact at scale.
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Where pharma comes together 6-8 OCTOBER 2026. MILAN, ITALY.
Discover new ideas Meet new partners Create new opportunities
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GREEN INDUSTRY GROWTH How Collaboration Can Turn Pharma’s Sustainability Ambitions Into Action The pharmaceutical industry faces the challenge of expanding access to life-saving medicines while reducing the environmental impact of discovering, manufacturing, packaging and distributing them. To overcome this challenge, the two goals cannot be treated as competing priorities. Patient health depends on a resilient pharmaceutical system, but that system requires sustainable energy supplies, reliable water resources, functioning infrastructure and healthy communities. This means that sustainability can no longer be an afterthought within the wider pharmaceutical value chain. Sustainability challenges cannot be solved by a single company, supplier, region or function in isolation. In this article, Silvia Forroova, Director of Partnerships & Sustainability at CPHI and founder of the CPHI Sustainability Collective, explores why collaboration across the pharmaceutical value chain is essential to turning sustainability ambitions into practical action, and where some of the greatest opportunities for progress lie. This will be discussed further at the upcoming CPHI Sustainability Summit, taking place on day one and two of CPHI Milan, on 6-7 October, 2026. The Summit is a two-day collaborative platform, designed exclusively for pharmaceutical industry professionals committed to accelerating sustainable transformation across the entire value chain, in a discussion-focused event. Find out more about the Summit and ticket registration at cphi.com/europe/ sustainability-summit/. A Global Challenge With Regional Realities Sustainability challenges are a genuine global concern, but the specific pressures companies face, and the solutions available to them, can vary significantly depending on local conditions. Global organisations need common expectations without assuming that every supplier or manufacturing site starts from the same position. Across different markets, similar challenges emerge as shared priorities for pharmaceutical companies and their supply chain partners: •
Scope 3 emissions: Among the most complex universal challenges, Scope 3 emissions lie outside of a pharmaceutical company’s direct operations but account for a significant share of its environmental footprint. Meaningful progress depends on broad and sustained supplier engagement.
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Regulatory fragmentation: Differing frameworks, reporting expectations and compliance environments are a persistent challenge, particularly for multinational
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organisations, as they can make it difficult to establish consistent sustainability practices across markets. •
Supply chain transparency: Whether sourcing from India, China, Europe or the Americas, companies need greater visibility into supplier practices and environmental performance. The pathway to overcoming global sustainability challenges varies by geography. Renewable energy availability, water stress, infrastructure, finance, regulation and supplier maturity all influence what is achievable in a specific region or market and how quickly. Europe benefits from relatively established renewable-energy infrastructure, while major Asian manufacturing markets face different transition timelines shaped by scale and national priorities. Emerging pharmaceutical hubs are also investing rapidly in new production capacity, creating opportunities to embed sustainability from the outset. Differences between regions are why a one-size-fits-all model is unlikely to work. Global expectations should provide direction, while implementation reflects regional realities.
Building Sustainable Capabilities Through Global Partnerships If the industry is to make meaningful progress, sustainability expectations should be clear and matched with the practical support required to meet them. Rather than simply asking suppliers to meet a standard and penalising those that fall short, buyers can help create the conditions for improvement
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GREEN INDUSTRY GROWTH through technical assistance, knowledge transfer, access to solution providers and longer-term commercial commitments that make investment more viable. Some sustainability challenges are too broad and systemic for individual companies to tackle effectively on their own, making industry-wide collaboration essential to meaningful progress. Shared environmental standards can provide a common direction for the industry, while collective investment in areas such as infrastructure, supplier capability and greener manufacturing methods can remove barriers that no single company could address as effectively alone. Setting boundaries between collaboration and market competition is an effective way to address sustainability challenges. Industry-wide issues, such as infrastructure, standards and foundational research, are areas where shared solutions can accelerate progress. Companies can still differentiate through implementation excellence, customer-specific solutions and proprietary innovation. Concerns around intellectual property, commercially sensitive data, antitrust rules and cost-sharing can all limit how openly organisations work together, particularly where the commercial benefits of sustainability investments are unevenly distributed. Neutral industry forums can help overcome some of these barriers by giving customers, suppliers, manufacturers and solution providers a space to discuss shared challenges and identify practical areas for cooperation. The real measure of success is whether those discussions lead to sustained action and measurable progress. Delivering on Sustainability Commitments The pharmaceutical sector has made ambitious sustainability commitments, but there is still a gap between targets and implementation. This can be illustrated by using Scope 3 emissions as an example. A company may have a credible net-zero ambition, but delivery requires engagement across a broad supplier network over many years. Circular economy commitments face a similar challenge, with recyclability and waste-reduction goals more common than genuinely closed-loop systems. Organisations that successfully move beyond ambition and pilot projects tend to share several characteristics: •
Executive accountability: When sustainability is a business priority and environmental metrics influence leadership decisions, investment and performance expectations, these metrics are more likely to shape day-to-day choices.
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Cross-functional integration: Sustainability is impacted by sourcing, development and manufacturing choices. Embedding sustainability in procurement, R&D and operations rather than leaving it with one specialist team helps make the most consequential environmental choices.
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Supplier partnerships: Joint innovation, shared targets and regular dialogue can help suppliers build capability while giving buyers greater visibility into practical barriers and moving engagement beyond compliance audits.
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Transparent reporting: Communicating progress, including setbacks, creates accountability and helps maintain
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momentum and highlights where further intervention is needed. •
Dedicated resources: Without skilled practitioners, clear ownership and sufficient budgets, sustainability targets are unlikely to translate into sustained change.
Industry collaboration and productive forums should create tangible outputs such as working groups, shared frameworks, specific commitments and progress measures. Knowledge exchange matters, but continuity and peer accountability are what turn discussion into momentum. Green Chemistry as a Practical High-Impact Opportunity Green active pharmaceutical ingredient (API) manufacturing is an opportunity to make tangible sustainability gains. Solvent selection and recovery are particularly important because solvents account for a large proportion of pharmaceutical synthesis waste. Although moving towards greener solvents and improving recovery can create substantial environmental benefits, translating these technical opportunities into widespread commercial adoption remains a significant challenge. Changing an established API process can require revalidation, resubmission of regulatory filings, capital investment and technical risk. Wider adoption will depend on reducing this friction while strengthening alignment between pharmaceutical companies, raw-material suppliers and outsourcing partners, such as contract development and manufacturing organisations (CDMOs). Greater regulatory clarity around sustainabilitydriven process changes would help, as would industry collaboration that enables organisations to share lessons from successful green chemistry scale-ups without surrendering proprietary advantage. Financial incentives or preferential procurement for more sustainably manufactured APIs could also strengthen the investment case for green chemistry. Sustainable Packaging Innovation That Maintains Product Safety Pharmaceutical packaging presents another major opportunity, but also one of the clearest tensions between environmental ambition and patient protection. Any change must continue to meet non-negotiable requirements around safety, stability, sterility, usability, regulatory compliance and anti-counterfeiting. Within those constraints, several areas offer meaningful potential: •
Material innovation: Mono-material solutions and pulp-based fibre alternatives may reduce reliance on difficult-to-recycle multi-layer combinations where product requirements allow. Biodegradable or compostable materials may also have a role in suitable applications.
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Design optimisation: Packaging can be optimised without compromising performance. Thinner but stronger films can lower material consumption, modular formats can make components easier to separate and digital patientinformation portals may reduce dependence on paper inserts where appropriate.
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Circular models: Closed-loop recycling partnerships can address what happens after use. Materials can re-enter
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GREEN INDUSTRY GROWTH reduce risk and build resilience. Scenario analysis can help demonstrate the potential cost of inaction compared with proactive investment. •
the supply chain and post-consumer recycled content can reduce demand for virgin materials where regulations permit. Packaging innovation should account for environmental impact alongside the industry’s existing requirements for safety and performance. Lifecycle analysis can help assess impacts across production, use and disposal, while early regulatory engagement can clarify which sustainability-driven changes are both feasible and compliant. Supplier Collaboration as a Source of Resilience Supplier engagement is essential to improving environmental performance across the pharmaceutical value chain, while also helping to build stronger, more resilient commercial relationships. Questionnaires and periodic audits are standard approaches to assessing sustainability performance within partnerships. A mature buyer-supplier relationship goes beyond this with long-term commitments and joint goal-setting, built on regular communication. Multi-year contracts can give suppliers greater confidence to invest in new equipment or processes, while technical assistance and knowledge transfer can help close capability gaps. On the commercial side, sustainability programmes can improve supply-chain resilience, reduce costs through efficiency, support market access, mitigate regulatory and reputational risks and unlock supplier innovation. Deeper supplier collaboration is also the only credible route to meaningful Scope 3 reductions. When suppliers improve their own practices and influence their suppliers in turn, capabilitybuilding extends beyond a single commercial relationship. Measuring Value Beyond Short-Term Savings Beyond immediate cost reduction, sustainability investment can support commercial performance, reduce exposure to future risks and strengthen the organisation over the longer term. Leaders should consider a broad range of strategic outcomes: •
Commercial value: Sustainability initiatives can bring stronger market access, product differentiation and new market opportunities. As customer expectations evolve, sustainability performance can influence purchasing decisions and competitive positioning.
•
Risk and resilience: Stronger supply continuity and reduced exposure to regulatory or reputational disruption
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Organisational value: Improved sustainability performance can provide access to capital, stronger investor relations and improved talent attraction and retention. Sustainability can also drive process innovation and encourage more efficient ways of operating.
The most persuasive investment cases combine quantitative evidence with strategic narrative. Peer benchmarking, pilot results and market research can demonstrate commercial relevance, while regulatory trajectory, stakeholder expectations and risk assessment explain why delaying action may create greater costs later. A Shared Opportunity for the Industry For collaboration to drive meaningful change, sustainability efforts need to reflect the realities of the entire pharmaceutical value chain. That means recognising that companies operate with very different levels of resources, infrastructure and technical capability, and ensuring that smaller organisations and suppliers in emerging markets are not excluded from progress. More consistent approaches to measurement and reporting could also help create a clearer basis for comparison, making it easier to identify what works and where further support is needed. Building that inclusivity and consistency into industry-wide efforts will be essential if sustainability ambitions are to translate into practical change at scale. Industry forums and neutral collaboration platforms have an important role to play in bringing different parts of the pharmaceutical value chain together, creating space to share practical experience, build trust and identify areas where joint action can accelerate progress. Their value is greatest when those conversations continue beyond the event itself, through working groups, shared commitments and clear measures of progress. In this way, forums can help turn individual sustainability efforts into more coordinated, industry-wide action. The future of pharma depends on our ability to deliver life-saving medicines while protecting the sustainability of our planet. That future will be built through partnerships across companies, functions, suppliers, regions and the wider ecosystem and not in isolation.
Silvia Forroova Silvia Forroova is Director of Partnerships & Sustainability for the CPHI portfolio at Informa Markets. With over 18 years' experience in global events, she specialises in strategic partnerships within the pharmaceutical industry. She leads sustainability initiatives across CPHI and is Founder of the Sustainability Collective, an impact network bringing together pharmaceutical industry change-makers to collaborate, share insights and drive tangible progress on sustainability challenges.
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GREEN VISION Carbon Footprints: Ypsomed's Path to More Sustainable Selfcare In this article, Sabine Huber and Thuysi Dao explore how sustainability is being integrated into self-injection device development at Ypsomed, from ecodesign and material selection to circularity, manufacturing, and collaboration across the value chain. A New Design Brief For pharmaceutical companies developing self-injection devices, sustainability is increasingly becoming part of the platform selection process. The environmental impact of a device is influenced long before manufacturing begins, making early engineering decisions increasingly important alongside performance, usability, and regulatory considerations. This thinking is reflected in Ypsomed's holistic approach to product development that considers the entire product life cycle. Rather than treating sustainability as a separate initiative, environmental considerations are incorporated throughout product development, from material selection and manufacturing through transport, use, and end-of-life. This approach is supported by ecodesign principles that guide the development of new platform devices. Design teams evaluate opportunities to reduce material consumption, improve recyclability, optimise packaging, and lower the product's carbon footprint across its lifecycle while maintaining the quality, safety, and performance required for drug-device combination products. Material selection is one of the earliest and most influential opportunities to apply this approach in practice. As part of the mass balance approach, Ypsomed has introduced bio-based plastics across multiple platform products, reducing cradle-togate CO2 emissions while maintaining the same material properties and regulatory expectations as conventional fossil-based plastics. At the same time, newer platform designs reduce material usage, simplify disassembly, and improve recyclability while upholding device functionality. Product development also extends beyond the device itself. Packaging, manufacturing processes, supplier collaboration, and logistics all contribute to overall environmental performance. Because approximately 98% of Ypsomed's carbon footprint lies within the upstream and downstream value chain, sustainability improvements depend on close collaboration with suppliers and pharmaceutical partners throughout the product lifecycle. Instead of addressing sustainability through isolated changes later in development, pharmaceutical companies can begin with
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device architectures that have already been engineered with lifecycle optimisation in mind. The Bigger Picture Lifecycle thinking becomes even more important when the carbon footprint of a medical device is examined in detail. Greenhouse gases caused by human activity, such as CO2 and methane, intensify the greenhouse effect and contribute to climate change. To achieve the goals of the Paris Climate Agreement, rapid and significant reductions in emissions are necessary. The Ypsomed Group is committed to achieving net-zero emissions across the entire value chain by 2040. In 2025, Ypsomed's direct and energy-related emissions (Scope 1 and 2) accounted for only 2% of total emissions, primarily due to heat consumption. The company already sources 100% of its electricity from renewable energy sources. The vast majority of emissions originate in upstream and downstream activities (Scope 3), with purchased goods and services accounting for the largest share of the carbon footprint. (Figure 1) This distribution highlights one of the fundamental challenges of decarbonisation in the medical technology and device industry. While Scope 1 and 2 emissions can often be addressed through measures such as renewable energy or improved energy efficiency, Scope 3 emissions depend on activities across the wider value chain. Material suppliers, manufacturing partners, logistics providers, pharmaceutical companies, and end-oflife systems all contribute to the overall environmental footprint of a self-injection device. Reducing these emissions therefore requires a broader perspective that extends beyond the boundaries of any single manufacturing site. Reducing Scope 3 emissions is also challenging as it is closely linked to growth and developments across the global value chain. Achieving ambitious Scope 3 targets requires close collaboration with suppliers and customers. Together with suppliers, partners, and customers, Ypsomed is driving the decarbonisation of materials, processes, and products along the value chain while continuously refining CO2 reduction measures to progress towards its target pathway. To reduce CO 2 emissions, Ypsomed is pursuing a comprehensive climate initiative through its NetZero Programme. The company works closely with customers and suppliers,
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Figure 1: Carbon footprint across the value chain according to the Greenhouse Gas Protocol (2025). The data includes Ypsomed AG and its subsidiaries.
focusing on decarbonisation, efficiency improvements, sustainable material cycles, ecodesign, and innovative solutions. A key lever for advancing these efforts lies in product development. New platforms are consistently developed according to this approach. This allows the CO2 footprint to be reduced, material selection to be optimised, and recyclability to be increased. Engineering the Difference If environmental impact is largely determined during product development, the next question is how that is translated into engineering decisions.
construction based on a single recyclable polymer stream, the use of bio-based plastics to reduce reliance on virgin fossilderived polymers, and a multi-use cartridge architecture that can replace multiple disposable autoinjectors within a monthly treatment regimen. YpsoLoop, our new, multi-award-winning autoinjector, also adheres to ecodesign principles and is designed for automated disassembly. (Figure 2)
Ypsomed's carbon footprint confirms that the production and disposal of the material it procures, such as plastic granulate, represents the largest share of its CO2 footprint. That is why Ypsomed has taken targeted measures to develop products with reduced CO2 emissions and improved recyclability. Already within product development, the CO2 footprint is analysed across the entire lifecycle and design, material selection, and packaging are optimised according to ecodesign principles. From very early product development stages until the final product, Ypsomed analyses the carbon footprint, share of renewable material in the product, amount of material used, and recyclability of the product. This analysis is systematically used to make the right concept choices and optimise the product until it meets the sustainability targets. Since 2023, YpsoMate 1.0 and YpsoMate 2.25 autoinjectors have been commercially available with reduced CO2 emissions, enabled by the use of bio-based plastics in the NetZero Programme. The UnoPen platform is also available with bio-based plastics made from second generation feedstock, while the next generation of products is being optimised according to ecodesign principles. Recent platform developments illustrate how these principles are translated into product design. YpsoFlow integrates environmental considerations from the outset through an ecodesign approach, using only two bio-based plastics to streamline material sourcing and reduce environmental impact. YpsoDot applies similar principles through a mono-material
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Figure 2: YpsoFlow, YpsoDot and YpsoLoop: since 2021, Ypsomed has applied ecodesign principles to all new product development
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GREEN VISION Together, these platforms demonstrate how environmental impact can be addressed through both material selection and product architecture while maintaining the usability and performance expected of modern self-injection systems.
Responsible sourcing is central to credibility. Ypsomed prioritises waste-based feedstocks to avoid deforestation and competition with food crops, and excludes first-generation biomass routes to minimise land-use concerns. (Figure 3)
Ecodesign therefore means more than simply selecting materials with lower environmental impacts. It also considers how products are constructed, how efficiently they use materials, how easily they can be recycled, and how their environmental impact can be reduced across the entire lifecycle. This broader perspective naturally leads to the next stage of sustainability thinking: designing products not only with a lower carbon footprint, but also for circularity. The practical application of these principles can already be seen in Ypsomed's latest platform devices.
Within this framework, the use of bio-based yet chemically identical plastics is a significant first step that allows the cradleto-gate CO2 footprint of existing product platforms to be reduced by up to 50%.
What’s the Matter? A Question of Traceability, not Chemistry One example of ecodesign in practice is the use of bio-based yet chemically identical plastics according to the mass balance approach for the improvement of existing platforms already on the market. Rather than introducing entirely new polymers, this approach replaces fossil-based feedstocks with renewable alternatives while maintaining exactly the same chemical structure, mechanical properties, processing characteristics, and regulatory status. From a device manufacturer's perspective, this distinction is significant, as existing material specifications and performance characteristics remain unchanged, and no additional approval procedures are necessary. Because the polymers are chemically identical, they can be processed using existing manufacturing equipment and validated production processes. The change occurs upstream in the production of the polymer rather than within the medical device itself. This allows environmental improvements to be achieved without altering device functionality, patient handling, or clinical practice, while avoiding many of the technical and regulatory challenges associated with introducing entirely new materials. Independent certification bodies verify that defined volumes of renewable content enter the system and are correctly attributed downstream in a mass balance approach. ISCC PLUS certification provides chain-of-custody documentation, audit traceability, and standardised accounting rules. ISCC PLUS also requires compliance with sustainability criteria for bio-based materials, including the protection of high-biodiversity and high-carbonstock areas, respect for labour and human rights, responsible production practices, and compliance with applicable laws.
The Road to Circularity Material innovation is only one aspect of ecodesign. YpsoLoop demonstrates how sustainability can also be addressed through product architecture. Designed for circularity, it provides the convenience of a pre-filled, two-step, single-use device while enabling material recovery through a design made for automated disassembly and efficient recycling. Two mono-material subassemblies support efficient material separation and recovery, illustrating how environmental performance can be considered alongside usability from the earliest stages of product development. These two materials were also chosen for easy sorting after shredding, with recycling happening either by disassembly or shredding and sorting, depending on volumes and setup. Taken together, these examples show that ecodesign is not defined by a single material or technology. It is the result of multiple engineering decisions, each addressing a different stage of a product's lifecycle. The next step is ensuring that these products can participate in circular systems that keep valuable materials in use for as long as possible. Designing products for lower environmental impact is only part of the challenge. To maximise the value of materials and reduce waste over the long term, products must also be designed with circularity in mind. Ypsomed is committed to the circular economy through ecodesign of new products, exploration of disassembly technology, choice of easily separable and recyclable material combinations, and collaboration with industry partners to exchange on existing and developing recycling streams. Circularity extends beyond designing recyclable products. Design makes recycling possible, while take-back makes it happen. Product design can reduce material complexity and enable more efficient recycling, but recovering those materials also depends on collection systems, recycling infrastructure, and collaboration across the healthcare value chain. Products therefore need to be designed not only for performance and
Figure 3: The mass balance approach.
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GREEN VISION manufacturability, but also for realistic recovery and material reuse at the end of their lifecycle. Ypsomed is in close contact with many recycling companies to understand their needs, the different recycling technologies, and how our products need to be designed to enable easy recycling. This lifecycle commitment also applies to packaging. Since 2021, the Ecodesign Guideline has promoted more sustainable product and packaging design throughout the Ypsomed Group. Transport packaging for the YpsoMate and YpsoMate 2.25 platforms has been converted to recycled PET (rPET), reducing CO2 emissions while promoting resource reuse. Through its Sustainable Packaging project and collaboration within the Alliance to Zero network, Ypsomed is also developing reusable transport solutions and return systems together with customers and partners. (Figure 4)
Figure 4: Closing the loop: connecting design, production, use, and material recovery.
A Value Chain Reaction Reducing CO2 emissions across the value chain requires close collaboration with suppliers. Through its Sustainable Purchasing Programme (S-PUR), Ypsomed actively involves suppliers in its net-zero ambitions, focusing on material groups with high emission potential. Climate protection requirements are embedded within the Supplier Code of Conduct, while workshops with internal and external partners identify opportunities such as lower-carbon materials, recycled materials, and process improvements. Expanding emissions transparency also allows climate performance to become an increasingly important consideration in supplier collaboration and procurement decisions. Collaboration is needed beyond the supply chain. As a founding member of the Alliance to Zero, a non-profit association established in 2021, Ypsomed helped launch an industry-wide initiative to accelerate the pharmaceutical sector's transition towards net zero emissions in line with the Paris Climate Agreement. Recognising that meaningful decarbonisation requires collaboration beyond individual organisations, the Alliance brings together companies from across the pharmaceutical supply chain to develop common approaches, harmonise sustainability principles, and advance practical solutions with broad industry acceptance. This reflects a broader reality discussed earlier in this article: technical feasibility alone does not guarantee adoption.
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Decarbonisation requires coordinated action across resin suppliers, device manufacturers, pharmaceutical companies, healthcare systems, and recycling partners. Through the Alliance to Zero, alongside collaborations such as BioPhorum and the Subcutaneous Drug Development & Delivery Consortium, Ypsomed works with stakeholders and industry peers across the value chain to help address these systemic challenges and accelerate the adoption of more sustainable drug delivery solutions. Internally, the Ypsomed Sustainability Academy supports knowledge sharing and helps strengthen sustainability expertise across the organisation. Energy Efficiency and Highest-Standard Production Sites Manufacturing also contributes to decarbonisation efforts. Plastic injection molding is inherently energy intensive, making energy efficiency a key focus. Measures such as waste heat recovery, energy-efficient injection moulding, smart building technology, and the use of 100% renewable electricity help reduce operational emissions while supporting continued production growth. Investments in photovoltaic systems and heat recovery further increase the share of renewable energy across production sites. The same approach guides the development of new production facilities, embedding environmental considerations into planning, design, and construction from the outset. The Changzhou manufacturing site was awarded LEED Platinum certification and the Chinese Green Building Label through measures including solar power generation, geothermal heat pumps, rainwater utilisation, recycled construction materials, and intelligent building design, making it one of the most sustainable industrial buildings in the world. Similar sustainability principles are being incorporated into new production facilities in the United States and Germany, demonstrating how environmental considerations are being integrated throughout future manufacturing capacity. (Figure 5)
Figure 5: With its new facility in Changzhou, China, Ypsomed is setting the standard for sustainable construction
Together, these initiatives demonstrate that sustainable drug delivery cannot be achieved through product design alone. Ecodesign, responsible sourcing, efficient manufacturing, and collaboration across the value chain each address different parts of the environmental challenge. Their combined impact is far greater than any individual measure in isolation, creating the foundation for more sustainable self-injection systems throughout their entire lifecycle.
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Figure 6: YpsoMate 1 mL, commercially available in the NetZero Programme
The Journey Ahead As sustainability expectations continue to evolve across the pharmaceutical industry, product development is becoming an increasingly important opportunity to reduce environmental impact. While manufacturing, logistics, and energy efficiency remain essential, many of the decisions that determine a product's environmental footprint are made much earlier, during the design phase. Ecodesign provides a structured framework for addressing this challenge. By considering material selection, product architecture, packaging, recyclability, and lifecycle impacts together, it enables environmental performance to become an integral part of engineering rather than a separate objective. The examples presented throughout this article demonstrate that meaningful progress can be achieved without compromising the quality, safety, usability, or regulatory robustness expected of modern self-injection systems. At the same time, no single product or organisation can deliver sustainable healthcare alone. Real progress depends on collaboration across the value chain, bringing together pharmaceutical companies, device manufacturers, material suppliers, healthcare providers, and recycling partners to develop solutions that extend beyond individual products. For Ypsomed, sustainability is therefore not defined by one technology, one material, or one initiative. It is a continuous engineering and collaboration process that spans the entire product lifecycle, from the earliest design decisions through manufacturing, use, and ultimately the recovery of valuable materials. By embedding these principles into proven platform technologies today and the innovations of tomorrow, the industry
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can continue moving towards more sustainable drug delivery solutions without compromising the performance and reliability that patients depend on. (Figure 6)
Sabine Huber Sabine Huber has been Sustainability Manager at Ypsomed since 2020. She drives the development and implementation of the Ypsomed sustainability strategy and CO2 reduction path towards net zero, within the company and also with various stakeholders along the value chain. She is an environmental scientist with more than 15 years of experience in implementing environmental and sustainability goals in Swiss industrial companies. Email: sabine.huber@ypsomed.com
Thuysi Dao Thuysi Dao is Sustainability Innovation Lead and Associate Director at Ypsomed, where she advances sustainability and net-zero innovation within the Innovation Team. Her work focuses on sustainable drug delivery, eco-design, and circular economy initiatives. Before joining Ypsomed, she worked as a sustainability consultant and earned a master’s degree in international management, specialising in sustainability and innovation management. Email: thuysi.dao@ypsomed.com
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GREEN VISION Real-Time LCA: From Sustainability Reporting to Sustainable Action Though pharmaceutical organisations have more sustainability data than ever before, the value of this data often remains limited to one-off reporting exercises, rather than informing daily decision-making. The notion of drawing from accurate, updated data to inform each operational decision and limit adverse environmental impact currently appears complex and out of reach. Real-time, or near real-time, life cycle assessment (LCA) has the potential to make this notion a reality, as LCA already provides reliable and credible intelligence on product carbon footprint and other environmental impact categories. Real-time LCA for the pharmaceutical industry combines standard LCA methods with routinely updated operational data from manufacturing, procurement and logistics systems. The goal is decision-grade insight that teams can use during product, process and supply-chain decisions, not just after the fact. Operational changes (for example, in transport mode, energy mix, supplier or the bill of materials) are reflected in near real‑time product‑level impact results, turning LCA into an ongoing decision support capability rather than a retrospective reporting exercise. What Problem Does Real-Time LCA Solve? As understanding of the climate crisis and urgency of action have evolved, so too have requirements for businesses and industry. The result is that sustainability action and its required data has emerged in a fragmented and uncoordinated manner, in response to evolving expectations. Environmental performance in a single organisation is expressed through multiple, disconnected data sets or certifications, whether product LCAs, B Corp certification, or data gathered for frameworks such as the Carbon Disclosure Project (CDP). The fact that different teams, as well as external consultants or specialist providers, manage distinct sustainability responsibilities further exacerbates the issue (see Figure 1). Consequently, organisations frequently operate with: •
Duplicated data collection efforts, where similar information is requested multiple times.
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Inconsistent assumptions and methodologies, and inconsistent secondary databases (the databases converting kWh, kg or tonnekm into emission profiles, such as kg CO2e), system boundaries (what the footprint includes/excludes), and allocation rules (how shared impacts are split).
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Limited interoperability between systems, with sustainability data stored across spreadsheets, third-party platforms and internal databases.
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•
Minimal cross-functional visibility, meaning insights generated in one department are rarely accessible or actionable in another.
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Low reusability of results, where studies are difficult to update and quickly become out of date for operational decisions.
Technology companies refer to a ‘single source of truth’: a governed way to store and manage critical activity data so it is standardised, quality-checked and accessible across functions. To address the issues outlined above, pharma can learn from this approach by treating sustainability activity data (materials, energy, yields, transport, waste and supplier inputs) with the same discipline as financial or operational data. LCA offers a strong foundation for this, as a comprehensive method for quantifying productor even company-level environmental impact, underpinned by internationally recognised standards, including ISO 14040 and ISO 14044. Sector initiatives such as PAS 2090 are also emerging to improve consistency for pharmaceutical products specifically. However, for LCA to support fast-moving commercial environments, it must move beyond static, point-in-time studies and be integrated into organisational data systems so results can be refreshed when the underlying business data changes. What Are the Steps to Enabling Real-Time LCA? In collaboration with sustainability specialists and pharmaceutical manufacturers, work is underway to explore the development of a near real-time, product-level emissions model intended to serve as a ‘single source of truth’. The initiative aims to generate practical insights and establish a blueprint that other organisations can build upon. The project has identified three core building blocks (see Figure 2) to help transform static LCAs into decision-grade models. 1. Map and optimise internal data infrastructure The first step is bringing available data together. This entails
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Figure 1: Consolidating Sustainability Strategy
• • •
Methodological rigour Parameterised LCA modelling System integration.
To establish methodological rigour, organisations must first analyse relevant standards, regulations and frameworks. This includes: sector-agnostic standards such as ISO 14040 and ISO 14044, ISO 14067, and the Product Environmental Footprint (PEF); sector-specific frameworks, such as PAS 2090 and other pharma and medical-related methodologies and guidance documents; and lastly supply chain-specific requirements, to align as much as possible with supplier data structures and client expectations.
Figure 2: Building Blocks for Real-Time Life Cycle Assessment
mapping out the data collected by each team, clarifying ownership and accountability, determining which datasets are needed for sustainability and LCA purposes, and then assessing how this information should be presented and integrated. Gathering this primary data for the LCA model may appear to be an overwhelming task for some organisations; the key is to take an iterative approach, perhaps prioritising the accuracy and detail of data in the areas that contribute most to greenhouse gas emissions (e.g. energy‑intensive manufacturing steps, high‑impact raw materials or solvents, cold‑chain transport, or particularly wasteful or low‑yield processes). Ultimately, though, the goal is to create a standardised system for organising and managing sustainability data. 2. Design a sound LCA methodology for relevant, comparable and scientifically credible outputs Creating an LCA system suitable for organisational decisionmaking rests on three principles:
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‘Parameterising’ the LCA model is the point where it becomes dynamic. Instead of fixed inputs, features that vary across the product portfolio are defined as parameters. These parameters can include material compositions, energy consumption profiles, yields, transport distances, packaging configurations, and more. To determine what these variables should be, the model must be developed with its intended use cases in mind, such as product development, scenario analysis, supplier information or external reporting. Next, the parameters which are most decision-relevant must be selected, while allowing for future additions or modifications. Rather than rebuilding models for each assessment, users can input product-specific data into these predefined parameter fields, ensuring that all results are generated within the same consistent modelling framework (see Figure 3). In an API-enabled environment, parameterised models can be directly connected to enterprise data systems so that product data, bill of materials, or process information flows directly into the LCA model. Once this is set up, changes in material sourcing or energy use, for instance, can be evaluated across an entire portfolio, supporting strategic decision-making and continuous improvement. In the absence of integration with enterprise systems and user interfaces, LCA is a siloed activity, dependent on manual data collection and limited to expert users. Linking LCA models directly to internal data architectures ensures that sustainability
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Figure 3: Configurable and Parameterised LCA Model, Simapro 2026
calculations are based on the most current and consistent data available within the organisation, such as product specifications, procurement data or production metrics. Tailored user interfaces can be built on top of this integrated backend; R&D teams can explore designs through a dedicated interface, for instance, while
procurement may use a separate portal focusing on supplier impacts. Bringing these layers together not only transforms how LCAs are used by an organisation, it also shifts the roles of LCA experts.
Figure 4: The Sustainability Compliance Journey
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GREEN VISION Rather than producing one-off assessments (a significant undertaking in its own right), they become cross-disciplinary specialists with a broader focus on building resilient systems that help to mitigate environmental impact in the long-term. 3. Make data outputs actionable This third pillar for creating a real-time LCA model centres on usability. Without this piece, all efforts to collate and standardise data may be lost. Users across an organisation must be able to understand the system’s outputs to then make informed decisions. Even the least technical user should be able to look at the data and understand what they are looking at, why it matters, and how to implement change as a result. One practical way to make emissions information usable is to embed it into systems that teams already recognise. Lean manufacturing principles, particularly value stream mapping, where each step from order to delivery is diagrammed, are well established in pharmaceutical manufacturing. Rather than introducing a separate “sustainability language”, organisations can overlay LCA results onto value stream maps so teams can see where emissions occur, what drives them, and which process changes are likely to matter most.1 This improves the chances that footprint insights translate into operational action, because they appear in the same context as time, cost, quality and throughput decisions. Over time, using a consistent underlying dataset and method also improves comparability for internal reporting and supplier/customer discussions. Why Are Real-Time LCAs Especially Relevant Now? Early sustainability frameworks were primarily voluntary. However, as described earlier, layers of Environmental, Social and Governance (ESG) reporting have increased over time (see figure 4). In parallel, there has been a shift towards mandatory, auditable compliance where each claim must stand up to scrutiny. This shift is reflected at both regional and national levels. In the European Union, the Corporate Sustainability Reporting Directive (CSRD) substantially expands the scope and depth of sustainability reporting, demanding standardised ESG information, as well as forward-looking metrics. Meanwhile, under the Empowering Consumers for the Green Transition (ECGT) Directive, vague or unsubstantiated claims such as ‘environmentally friendly’ or ‘carbon neutral’ are prohibited unless they can be supported by verifiable evidence. In the UK, procurement frameworks are taking a stricter view on sustainability. The Evergreen Sustainable Supplier Assessment began as the National Health Service’s voluntary self-assessment tool. Today, it is increasingly integrated into procurement processes, in support of the NHS’ net zero goals for 2045. Compliance is therefore a commercial necessity, not simply a ‘nice-to-have’. Manufacturers in the pharmaceutical and medical device sectors cannot respond to this cumulative reporting burden in the same manner as before. This will simply exacerbate the existing issues of repeated data collection, reliance on external consultants, and escalating costs. However, the alternative is regulatory, legal and reputational risk. To facilitate the transition, and so that organisations can more easily respond to future sustainability requirements, the industry
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must transform its approach. This is the impetus for a real-time operational model: an agile system capable of absorbing live updates and producing insights ready to be translated into immediate action. The approach outlined in this article aims to move from abstract, high-level metrics to insights that teams can engage with, from single-use data to repeated scenario testing, from disengaged teams to strengthened buy-in, and from disjointed sustainability effort between customers and partners to meaningful collaboration. REFERENCES 1.
Lean Enterprise Institute, Value Stream Mapping https://www.lean. org/lexicon-terms/value-stream-mapping/
Serena Grace Serena Grace is Head of Sustainability at Owen Mumford, where she focuses on integrating sustainability into business decision-making. With a background in neuroscience, behavioural science and digital analytics, she specialises in translating complex sustainability and emissions data into practical insight. Her work supports product development, operations and supply chain strategy, and she holds postgraduate qualifications from the University of Oxford and University of Cambridge. Email: serena.grace@owenmumford.com
Marina Dumont Marina Dumont is an LCA Consultant at PRé Sustainability, where she leads life cycle assessment (LCA) and methodological work for the pharmaceutical and medical device sectors. She specialises in environmental assessment, regulatory compliance and life cycle thinking, advising organisations on harmonising LCA methodologies and embedding them strategically. Her work also focuses on developments related to Product Environmental Footprint (PEF) and PEF Category Rules (PEFCR). Linkedin: linkedin.com/in/marinadumont/
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GREEN VISION From Impossible to Circular: Unlocking Recycling Pathways for Pharmaceutical Packaging The pharmaceutical and healthcare packaging sector has reached a defining moment. Packaging formats such as blister packs, bottles, tubes, pouches, sachets, cartons and protective wraps are indispensable for ensuring sterility, dose accuracy and patient safety. Yet, once used, the overwhelming majority of this packaging follows a linear trajectory towards disposal or destruction. This linearity now stands in direct conflict with regulatory, environmental and societal expectations. Under the EU Green Deal, pharmaceutical packaging is no longer viewed as an exceptional category insulated from sustainability obligations. Instead, it is increasingly scrutinised as part of the broader packaging waste system – subject to Extended Producer Responsibility (EPR), recycled content expectations, and net-zero healthcare ambitions. Despite this shift, recycling rates remain alarmingly low. Estimates suggest that only around 14% of blister packs – enter any form of dedicated recycling stream.1 For many other primary and secondary pharmaceutical packaging formats, effective recycling pathways barely exist. Most materials are still incinerated or landfilled, often by regulatory default rather than by design. The question facing the industry is no longer whether pharmaceutical packaging must become circular, but how this can be achieved without compromising safety, compliance or performance. Why Pharmaceutical Packaging Has Been Left Behind Pharmaceutical packaging sits at the intersection of some of the most complex requirements in the packaging world. This starts with material complexity. Blister packs combine aluminium with multi-layer polymers. Tubes and pouches rely on laminated structures, adhesives and barrier layers. Bottles, closures and dispensers may incorporate pigments, additives and functional components to meet regulatory and performance standards.
These constraints help explain why pharmaceutical packaging has remained largely outside mainstream recycling systems. However, they do not justify inaction or the lack of development of innovative processes – particularly in light of evolving EU policy. PPWR and the End of “De Facto Exemptions” The EU Packaging and Packaging Waste Regulation (PPWR) represents a fundamental shift in how packaging is regulated. Unlike previous directives, PPWR introduces harmonised, binding requirements across Member States, with a strong emphasis on waste reduction, recyclability and recycled content. Crucially for pharmaceuticals, PPWR signals the end of implicit exemptions based on complexity or safety concerns. While certain medical and pharmaceutical packaging will require exemptions many more could become much more sustainable and the overall direction is clear: most packaging must be designed for circularity, and producers must take responsibility for its end of life. Under PPWR, claims of “non-recyclability” will increasingly require justification. The burden is shifting from regulators asking whether recycling is possible, to producers demonstrating why it is not.
Second, there is contamination risk. Packaging that has come into contact with active pharmaceutical ingredients (APIs) cannot be treated in the same way as consumer packaging waste. Conventional mechanical recycling processes are not designed to guarantee the level of decontamination required for high-value or regulated reuse.
This regulatory reality demands new thinking – not just about packaging design, but about the new systems that will support collection, sorting, decontamination and recycling.
Third, regulatory conservatism plays a role. Once a packaging format has been validated and approved, change is costly and time-consuming. This has historically favoured proven linear materials over innovative circular solutions.
Extended Producer Responsibility: From Cost to Catalyst Extended Producer Responsibility has historically been viewed by many pharmaceutical companies as a compliance cost rather than a strategic lever. That perception is rapidly changing.
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GREEN VISION As EPR schemes evolve, fees are increasingly modulated based on recyclability, recycled content and environmental performance. Packaging that lacks viable recycling pathways is likely to attract higher costs, greater scrutiny and reputational risk. Conversely, packaging formats that are supported by credible, scalable recycling systems can benefit from lower fees, regulatory confidence and long-term material security. EPR therefore has the potential to act as a catalyst for innovation, encouraging pharmaceutical companies to invest collectively in infrastructure and technologies that unlock circularity – rather than bearing escalating costs for linear solutions. Learning from “Impossible” Materials Working with some of the world’s most difficult-to-recycle materials consistently demonstrates that circularity in primarily a materials challenge – it is a systems challenge. Flexible food packaging, cosmetic packaging and high-performance medical plastics share many of the same challenges as pharmaceutical packaging: multi-material construction, contamination risk and demanding end-quality requirements. Traditional recycling systems were designed for conventional waste streams. Pharmaceutical packaging does not fit this model and never will. Expecting it to conform to municipal recycling norms is neither realistic nor necessary. Instead, the sector requires bespoke recycling pathways designed specifically to handle complexity, manage contamination and deliver compliant outputs. Supercritical CO2: Enabling Pharmaceutical-Grade Recycling One of the most critical barriers to circular pharmaceutical packaging is decontamination. Without robust, scalable methods to remove chemical residues and absorbed substances, recycled polymers cannot safely re-enter regulated applications. Solvent-assisted COtooCLEAN™ technology addresses this challenge directly. The process uses supercritical carbon dioxide to extract contaminants from polymers at a molecular level. In its supercritical state, CO2 combines the penetration properties of a gas with the solvating power of a liquid, allowing it to potentially remove APIs, additives, oils and odours without degrading the polymer itself. Unlike solvent-based or high-temperature processes, COtooCLEAN™ leaves no residual chemicals, preserves polymer performance and has a low carbon footprint. This enables recycled materials to meet demanding quality and safety thresholds – opening the door to high-value, regulated re-use. For pharmaceutical packaging, this represents a step-change: materials previously deemed unsuitable for recycling can potentially be purified to a level compatible with circular systems. Beyond Blister Packs: A System-Wide Challenge Blister packs are often highlighted as the emblem of pharmaceutical packaging waste but focusing solely on blisters risks overlooking a broader opportunity.
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The pharmaceutical sector generates a diverse stream of plastic and fibre-based packaging, including bottles, tubes, pouches, sachets, cartons and protective films. Collectively, these materials represent a significant environmental footprint – and a significant opportunity for circularity. Achieving meaningful progress requires addressing this entire ecosystem, rather than treating each format in isolation. SusPack: A Blueprint for Circular Healthcare Packaging This systems-led approach underpins SusPack, an Innovate UK-backed collaborative project bringing together Nextek, University of Nottingham and University of Kent through to NPL for materials science and measurement, Sealeo Ltd for packaging solutions, CPI for pilot-scale innovation, Bridge Farm Bioscience Ltd for biotech expertise, The Naked Pharmacy Ltd for pharmaceutical packaging insight, Impact Recycling Ltd and ReVentas Ltd for recycling operations, Alga (Seaweed) Ltd for sustainable biomaterials, and Impact Solutions Ltd for consulting and systems integration. Collectively, they are developing scalable, compliant recovery pathways for a wide range of pharmaceutical packaging formats. The project focuses on real-world implementation. Its objectives include: •
Developing advanced sorting and separation processes for complex healthcare packaging
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Applying supercritical CO2 decontamination and delamination processes to achieve pharmaceutical-grade recycled polymers
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Demonstrating alignment with regulatory and safety requirements
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Creating replicable models that can support EPR compliance and PPWR objectives
SusPack illustrates how cross-sector collaboration can overcome challenges that no single organisation can solve alone. Redefining Recyclability in a Regulated Context A persistent misconception in sustainability debates is that packaging must be compatible with household recycling to be considered recyclable. For pharmaceutical packaging, this assumption has been deeply limiting. Pharmaceutical packaging requires controlled, traceable systems that reflect the sector’s regulatory realities and keep it separate from domestic waste streams. Such systems already exist in other regulated industries, from medical devices to industrial chemicals. Applying similar thinking to pharmaceutical packaging is both logical and necessary. Net-Zero Healthcare and Material Responsibility With healthcare accounting for 4–7% of national greenhouse gas emissions in many developed economies, healthcare systems across Europe have committed to ambitious net-zero targets, and pharmaceuticals are a major lever for change.
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In the UK, the NHS has committed to net-zero for directly controlled emissions by 2040, and for the full supply chain by 2045. EU health systems have aligned with the European Green Deal and Fit for 55, focusing on decarbonising public procurement, medical supply chains and waste. Packaging, while only one component of healthcare emissions, is a visible and addressable contributor. Incineration and landfill not only represent a loss of material value but also generate avoidable carbon emissions. Circular packaging systems, by contrast, reduce reliance on virgin polymers and lower lifecycle emissions. For pharmaceutical companies, investing in circular packaging is therefore not just an environmental imperative, but a strategic contribution to net-zero healthcare goals. From Incremental Change to Systems Transformation The pharmaceutical industry is rightly risk-aware. Patient safety must always come first. However, safety and sustainability are not mutually exclusive. The technologies, policy frameworks and collaborative models needed to unlock circular pharmaceutical packaging now exist. What is required is the willingness to move beyond incremental change and embrace systems-level transformation. A Call to Action The transition from linear to circular pharmaceutical packaging is underway – and it will accelerate under PPWR, EPR reform and net-zero commitments. Pharmaceutical leaders must engage early, collaborate across value chains and invest in solutions that address end-of-life challenges directly.
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Packaging designers and sustainability teams must focus not only on design for recyclability, but on creating pathways that function in practice. Policymakers and regulators must continue to recognise and enable advanced recycling and decontamination technologies that make circularity possible. Materials that protect patient health should not compromise planetary health. By rethinking how pharmaceutical packaging is recovered, decontaminated and re-used, the industry can move from impossible to circular – and help deliver a genuinely sustainable healthcare system. REFERENCES 1.
https://pmarketresearch.com/chemi/pharmaceutical-recyclableblister-packaging-market/
Edward Kosior For over four decades, Edward has been at the forefront of innovation in polymer technology, driving change across recycling ventures and as the visionary Founder and Managing Director of Nextek. A holder of multiple patents in plastic recycling, he has played a pivotal role in bringing recycled PET, HDPE, and PP into mainstream food packaging across Europe, Asia, Australia and the Americas. Beyond packaging, he is deeply committed to tackling plastic pollution in our oceans and championing science-based solutions and best practices to address the environmental challenges faced by developing nations.
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GREEN VISION The Limits and the Opportunities of Plastics for Recycling
Global economy will triple by 2060 and this will drive the use of plastics. According to a OECD study “Global Plastics Outlook 2060” (2022), plastics use reached 460 Million tonnes (Mt) in 2019, and projections based on population growth trends and higher incomes in emerging economies will lead to 1231 Mt in 2060. Consequence of this is the generation of 353 million tons of plastic waste, that are projected to triple up to 1014 Mt in 2060. Plastic waste represents nowadays a big problem, but it can turn into a valuable resource if shared objectives and coordinated efforts to reduce plastics pollution at global level will be implemented. These could drastically reduce the projections of plastic use and waste for 2060 by more than 30% (global ambition policy scenario 2060), if all relevant phases of the plastics lifecycle are targeted. In this article we will discuss some of the key plastics lifecycle steps, with particular emphasis on plastics recycling, their existing different types (e.g. mechanical recycling or chemical recycling) and the limits and opportunities of them. Good news is that 29 Mt of plastics use was satisfied by plastics recycling on the base year 2019, but this is still too low proportion, compared to the higher 431 Mt contribution of primary plastics. Projections of plastics recycling in 2060 without coordinated global and regional action could reach 143 Mt (5 times the 29 Mt of 2019), counting for a plastics lifecycle that would only be 14% circular in 2060 (=143 Mt out of 1014 Mt of plastic waste). Mechanical recycling represented nearly the entirety of the 29 Mt figure, as it was the only commercially mature processing infrastructure at scale in 2019. Chemical recycling on the other hand was in early and unquantified pilot stages. Mechanically recycling has a low environmental impact and an established infrastructure that must grow further, but there are some relevant limitations. The first limitation of mechanical recycling depends on the quality and purity of the waste input, visible when we compare the 29 Mt with the 55 Mt volume of plastics that was collected for recycling in 2019. This means that 22 Mt of plastic residues could not be mechanically recycled due to the materials composition or to the high level of degradation, mix and contamination. In addition, there were additional 4 Mt of process losses to be considered. The content of fillers (e.g. glass fibers) or of other component materials alone (e.g. multi materials) are very difficult to separate. In addition, the degradation of the polymer itself (e.g. molecular weight reduction, increase of monomer content depending on the considered polymer like BPA, formaldehyde,
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degraded halogen content etc..) and of the additives contained in the original formulation (e.g. flame retardants, colour pigments, UV additives, demolding agents etc..) make them not reusable and in some cases prejudicial for a second life purpose. Furthermore, waste feedstocks can come from virgin plastics that were already containing dangerous or restricted substances intentionally included (IAS: Intentionally Added Substances) to comply with their first life application purpose (e.g. FR materials with halogen content, Chlorinated organic compounds, etc..). Last but not least, there is the important issue of the Not Intentionally Added Substances (NIAS), that not only refer to the production of the plastic when it was a prime material, but also to the NIAS that will have migrated into the materials during the first application use, and after the end of life of the application, during the status of mixed waste plastics and during the recycling process itself. The study “Chemical content validation of recycled plastics” (OECD, 2026) quantifies in 13.000 the number of chemicals contained in virgin plastics alone, summing up IAS and NIAS substances. Several of them are chemicals of concern that can persist, migrate and accumulate in plastic waste, increasing environment and human health concerns. All these points set a second limitation of mechanically recycled plastics, which is related to the possible uses in existing applications: these are more restricted than prime plastics, as consequence of different reasons, like wider tolerances of material properties, lower batch stability or lower color properties. Considering the medical sector and medical device applications, mechanically recycled plastics or a compound of prime plastics with mechanical recycled content is not even an option, because the presence of NIAS accumulated during the first application use and the posterior waste status will make it impossible to pass Extractables and Leachables
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GREEN VISION (E&L) analysis and fulfil with key required properties like biocompatibility. These considerations underline the need for a plastic with recycled content that preserves the high quality of prime plastics on one side to fulfil with the sector application and on the other that guarantee higher efficiency outputs for the future collection at even bigger scale. For example, the 2022 OECD study projects 6 times higher volume plastics collection for 2060 (approx. 302 Mt from the 55Mt in 2019), with an estimation of 126Mt recycling residues and 33 Mt of process losses (scraps) in 2060. This would represent a 47% of recycling efficiency (143Mt out of 302Mt) on collected plastic waste for recycling, with a slight decrease from the 52% obtained on the base year 2019 (29Mt out of 55Mt). Here chemical recycling technologies can make the difference, introducing new ways to recycle collected plastic waste into higher quality feedstocks that can be reincorporated at progressively higher levels of the chemical polymer supply chain: from the polymer (dissolution), to the monomer (depolymerization), up to the direct alternative of the fossil oil (pyrolysis) as input feedstock alternative for the cracking process. By going up in the supply chain, the number of possible plastics that can be produced with the chemically recycled output increases, scaling up the volumes that can be produced. On the other hand, chemical recycling techniques need a strong push from regulatory authorities to promote investments, focus on synergies and cost optimization, create the missing part of the circular supply chain that needs to be put in place and let the existing chemical supply chain industry to adapt to their use. As starting point idea, compared to global petroleum production, the actual worldwide feedstock availability for chemical recycled plastics is very low, approximately 0.10% to 0.19% on a relative weight/mass basis. Considering the plastics lifecycle, a critical point is when the End of Life (EoL) of the device application is reached: here several and relevant plastics stream outputs are generated. Ideally, it would be fantastic to be able to convert 100% of the EoL plastic waste into collected waste input for recycling. The reality is completely different: there are not enough recycling infrastructures implemented in many regions and cooperating together, regulatory directives still need to be developed, put in place and coordinated in a global scenario, especially in emerging countries like Asia and Sub-Saharan Africa, where plastic use and waste production is going to grow at highest
pace. As result, 79 Mt of 353 Mt (approx 22%) of plastic waste was completely mismanaged on base year 2019 (OECD study 2022), leading not only to a lower base of collected plastic waste for recycling, but to the highest negative impact for the environment, from aquatic leakage (6Mt), terrestrial leakage (13Mt), Dumpsite (34Mt) and open-pit burning (26 Mt). Mismanaged plastic waste could double from 79 Mt to 153 Mt in 2060, similarly to plastics leakage, from 22 Mt (the mentioned aquatic and terrestrial leakages from mismanagement + leakages during plastics use and plastics production and logistics, approx 3Mt) to 44 Mt in 2060. On the other hand, if combined regional and global policies will be implemented with international engagement, there is a OECD projection of more than halving these estimations for 2060. Another important development drive for the chemical recycling segment is the need to divert plastic waste from landfills. Landfilling of plastic waste is the second worse option for the environment, that could triple from 174 Mt into 507 Mt in 2060 according to the OEC study. Plastics incineration (67Mt in 2019 with projection 179Mt for 2060) is an improved solution compared to landfilling. Partial energy recovery from the incineration process is possible, but there are high levels of CO2 equivalent emissions into the environment. According to the OECD study, plastics incineration volumes would also triple from 67Mt (base year 2019) to 179Mt (2060 projection). Chemical recycling is an important remedy to avoid landfilling of plastics waste and it is an optimal solution to reduce incineration volumes too. Most important, the output products are not just emissions with some energy recovery, but valuable new raw materials feedstock in solid, liquid (e.g. pyrolysis oil) or gas (e.g. syn-gas) form that can feed back again the chemical polymer supply chain to produce high quality plastics. In this way, circularity with waste feedstocks is created, emissions are reduced (especially compared to the incineration alternative) and energy recovery is enabled. Plastic waste can be collected and sorted by type (for example tires), recovered as new feedstock to produce high quality plastics (e.g. pyrolysis oil composed by liquid hydrocarbons) increasing recycling efficiency, requiring lower temperatures than incineration to operate and reduce emissions levels. As reference, the incineration process requires between 850° and 1100°C in presence of oxygen to ensure complete combustion and prevent the release of toxic pollutants. The use of only pre-sorted and specific types of waste let the fine tuning of the recycling process of those residues, reducing the amount of energy required for the process. In addition, to prevent fire and combustion (burning) of plastic waste, the oxygen is removed. This step is important in most chemical recycling techniques (except for gasification, where limited oxygen is needed for partial oxidation), otherwise the plastics waste would be consumed as fuel and turned into carbon dioxide, ash, and smoke instead of chemical recycling products. By applying high heat in a strictly oxygen-free or inert environment, the thermal energy acts like a pair of "scissors" rather than a flame. It vibrates and cracks the long polymer chains apart cleanly into smaller hydrocarbons without oxidizing them. Temperature levels along with the technology in use determine the grade of thermal breakage of plastics waste and therefore the type of feedstock output that can be obtained. This defines where that regenerated feedstock can
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be re-introduced as input raw material in the chemical plastics supply chain. Conversion chemical recycling uses 800–1000°C in the case of gasification and 300–900°C for pyrolysis (or liquefaction). Depolymerization chemical & solvolysis recycling uses temperatures between 150°C and 450°C (extending up to 800°C for thermochemical variants), while dissolution typically requires temperatures between 30°C and 200°C. For reference, mechanically recycling requires temperatures between 150°C and 300°C (to melt and reform the material without changing its fundamental chemical structure). Discussing waste, we referred to end of life plastics, but there is also another important type of waste that can be recycled into plastics. This is bio-waste, for example used cooking oil and tall oil from agricultural and forest waste. By hydrotreating such types of oils, Hydrogenated Vegetable Oils (HVOs) can be produced and refined into Bio-Naphtha. Bio-Naphtha can substitute fossil Naphtha as input feedstock for the petrochemical cracking process, which is the starting point of the polymers supply chain industry*. An example for ABS (Acrylonitrile Butadiene Styrene) is an existing biocompatible and bio-circular medical ABS grade which is ISCC+ certified bio-attributed origin from used cooking oil, agricultural waste and biogas. For plastics waste certified content, alternative versions with ISCC+ certified chemical recycled content from used tires are also available. These ABS grades are identical to the traditional fossil version and can be used as enclosure plastics in biocompatible medical device applications, fully fulfilling all medical regulatory requirements. By increasing the demand for alternative sustainable versions, without renouncing the primary plastics performances, it is possible to support the future recycling challenges. As we have seen for the case of ABS polymers, Bio-waste can be recycled to produce new conventional plastics that are normally associated to petroleum. The main sustainable
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advantages in this case are the use of bio-waste as feedstock, the fossil substitution and important CO2 emission reductions. Also, plastic waste can be recycled to produce again virgin plastics. It is important to raise awareness about chemical recycling technologies as parallel paths to move forward. The reasons are multiple: not only to complement mechanical recycling by reprocessing its residues and scraps (practically half of what is collected for recycling), but also to gradually address a set of even more relevant problems. These are: mismanaged plastics (which would double by 2060), plastics deposited in landfills (which would triple), and incineration high emissions without output feedstock for recycling (which would also triple by 2060). *see also my previous article published at IPI: “Certified ABS Plastics from Bio-Circular and Chemical Recycled Sources Instead of Fossil Ones”
Luca Chiochia Luca Chiochia, Business Development Manager. Graduated in management engineering at the "Politecnico di Milano" University (Milan, Italy), Luca has over 20 years’ industrial experience in the fields of plastics, composites, and OEMs devices. Luca joined ELIX Polymers in 2017 in the position of Business Development Manager for the healthcare strategic sector. Since 2020 he is actively involved in the development of ELIX E-LOOP sustainable solutions and circular innovations, that include a new growing sustainable ABS and blends material portfolio, with chemically recycled, bio-attributed, bio-circular and mechanically recycled content.
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GREEN VISION Just Breathe! Sustainable Initiatives Beyond the Green Transition In 2026, sustainability is more than a ‘buzzword’. It is a core strategic expectation essential for longevity and a robust value chain. Looking beyond the carbon footprint of manufacturing, a holistic approach to sustainability considers the environmental and social impacts across every stage of the value chain. Embedding sustainable business practices across the industry is both challenging and essential to building long-term resilience in a rapidly evolving market. Leveraging its position as a trusted market leader in pressurised Metered Dose Inhaler (pMDI) products and components, Bespak® is committed to growing responsibly, decarbonising its operations, and supporting the transition to low carbon pMDIs, supporting a more sustainable future for patients, customers and the wider industry. A ‘Greener Tomorrow’ Starts Today pMDIs are life-saving pharmaceutical devices used in the treatment of asthma, Chronic Obstructive Pulmonary Disease (COPD) and other chronic lung conditions. They are significant contributors to the healthcare-related carbon footprint, making up 3% of the UK’s National Health Service’s overall carbon emissions.1 Transitioning to low Global Warming Potential (GWP) propellants HFA-152a and HFO-1234ze(E), to reduce pMDI-associated emissions is an industry priority and Contract Development and Manufacturing Organisations (CDMOs) like Bespak have become increasingly essential in facilitating this shift. As the specialist inhalation CDMO, Bespak is committed to ensuring it has the capabilities, business practices and dedicated infrastructure in place to streamline and accelerate low carbon pMDI development and commercialisation, without compromising quality or continuity of care for patients. Ten years on from the Kigali Amendment to the Montreal Protocol, which sets phasedown targets for greenhouses gases, Bespak has cemented its leadership of the green transition, with a recently-announced commitment to supply the world’s first approved HFA-152a pMDI, building on its existing role in the supply of the world’s first approved HFO-1234ze(E) pMDI – These milestones serve to demonstrate that the transition is both achievable and underway. Building upon these momentous achieve-ments, the path forward has never been clearer. Industry-wide sustainability requires a multi-faceted approach and collective effort in making small actions that compound to bring about a positive difference. As the industry begins to look beyond the immediate transition to low GWP propellants, pharmaceutical developers must holistically assess their portfolios and operational practices to identify opportunities for meaningful change. Bespak is working
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to establish tools and services to help make this process easier and to support its customers in their mission to meet evolving patient needs. Regulatory Confidence Through Iterative Optimisation Achieving sustainability is an ongoing, iterative process requiring consistent planning, action and adjustment of strategy. Bespak is continuously striving to improve and sustainability metrics of the pMDI components, devices, and drug-device combination products it offers – but never at the expense of performance or quality. As switching propellants can affect formulation behaviour and dose delivery, component performance must be assessed with low GWP propellants in order to maintain quality and reliability of delivered dose. As the producer of almost half the world’s pMDI valves, Bespak has dedicated itself to combining its specialist knowledge with innovative technologies to help pMDI developers achieve their sustainability goals with regulatory confidence. Leveraging advanced in silico modelling techniques, digital engineering processes and in-house validation studies, Bespak continually is assessing the performance of its critical components when used with HFA-152a and HFO-1234ze(E). For example, the Bespak BK357 pMDI valve is the industry’s most trusted metering valve, known for its consistency in quality, performance and compatibility with a wide range of traditional hydrofluoralkane propellant formulations. By simulating in vitro aerosolisation performance and characterising real-time fill behaviour experimentally, Bespak was able to optimise the valve design to limit propellant leakage and moisture ingress. This led to successful, and even improved, performance compared to traditional propellants. Backed by data-driven enhancements, the BK357 valve is now the first valve approved for use in low carbon pMDIs. By accelerating the early stages
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GREEN VISION of formulation feasibility with its proven components and digital engineering capabilities.Bespak is supporting its customers in their transition to low GWP propellants and helping to put low carbon, life-saving medicines into the hands of patients faster. Sustainability as a Design Parameter Bespak is also actively exploring solutions for carbon reduction beyond the propellant switch, having recently completed its first Life Cycle Assessments for the BK357 valve, and other critical pMDI components such as its range of actuators, to better understand their carbon impact and identify emissions hotspots. Building on this, and using a digital-first approach, Failure Mode and Effects Analysis (FMEA) to find and fix design flaws before production, and fit-and-function frameworks, we are actively reducing reliance on the iterative, resource-hungry testing associated with reformulation or platform redesign. Bespak has also been working on tackling common challenges which can be difficult to predict but can significantly impact a product’s carbon footprint, such as manufacturing variability. Recent advancements in tolerance analysis allowed Bespak to map the design space of critical pMDI components and successfully identify opportunities for waste reduction. This knowledge directly benefits the customers who have access to Bespak’s rapid prototyping facility and other design services working to cut emissions across the full product lifecycle while ensuring quality and performance. By using environmental performance and eco-friendly manufacturing as non-negotiable parameters, Bespak has identified opportunities for wider device-level decarbonisation across raw material use, manufacturing, and performance testing. In conjunction with stringent process controls and raw material usage efficiency, these design considerations help Bespak to follow a ‘Right First Time’ framework. In 2025, Bespak produced over 690 million devices with a 99.65% manufacturing yield and no major deviations or product recalls. Bespak is dedicated to steering positive change and laying the groundwork for future advancements beyond next generation propellants. From cross-industry knowledge sharing for data-led design modifications, to implementing decarbonisation initiatives across the value chain, Bespak is already enacting meaningful change for patients and the environment. By supporting its customers in the development of targeted strategies for decarbonisation and reducing waste, Bespak helps them to progress their own sustainability ambitions while staying ahead of emerging regulatory requirements. Cutting Carbon Collaboratively Industry-wide sustainability requires collective effort. While individual organisations need to do their part, collaboration allows for complex challenges to be tackled that cannot be addressed alone. CDMOs can act as strategic partners for pMDI developers, providing the technical expertise and infrastructure necessary to help navigate changing market needs and future-proof upcoming commercial initiatives. To support its partners and the wider industry as global demand increases, Bespak has expanded its GMP facilities at its Holmes Chapel site, with fully operational commercial-scale filling lines for HFO-1234ze(E) and clinical-scale filling for HFA-152a (with full commercial-scale readiness on track for 2027). By targeting investment into its capabilities and manufacturing
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capacity, Bespak is strengthening its position as the long-term innovation partner and sustainability leader in inhaled and nasal drug delivery. Bespak has also recently expanded its partnership with the Chiesi Group. The award-winning enhancement at the Holmes Chapel site directly supports Chiesi’s Carbon Minimal Inhaler (CMI) programme and wider goal to reach Net Zero by 2035. The CMI programme aims to reduce the carbon footprint of pMDIs by up to 90% to reduce environmental impact without impacting established treatment options and continuity of care. Reinforcing a trusted relationship, the expanded collaboration leverages Bespak’s specialist knowledge and leadership in low GWP pMDI manufacturing to help deliver lower carbon inhaled therapies at scale, and strengthen Chiesi’s supply chain resilience, responsibly and with confidence. Both companies are committed to addressing climate change through measurable, science-based action, and this collaboration will help both partners make tangible progress towards their individual and collective sustainability ambitions. The expansion of the Holmes Chapel manufacturing site also firmly establishes Bespak as part of a collaborative network of experts who are collectively leading global pMDI development. This specialist pMDI hub in the Northwest of England consolidates the pMDI supply chain, mitigating collective risk and reducing transport carbon costs through the pooling of capabilities, manufacturing equipment and resources locally. Bespak’s improved manufacturing capacity that more customers now have access to its HFA-152a and HFO-1234ze(E) capabilities, supporting them in their propellant transition and helping to ensure robust global supply. But, building upon this, we remain is committed to solidifying our position as an industry pacesetter, and will continue to seek out opportunities for collaboration and cross-industry knowledge sharing, to augment this global centre of excellence and encourage the co-creation of green solutions for collective advancement. Beyond the Green Transition – Next Steps for a Low-Carbon Future In September 2025, the Science Based Targets initiative (SBTi) validated Bespak’s near-term target to reduce Scope 1 and 2 greenhouse gas (GHG) emissions by 54.6%, and its long-term net-zero target to reduce Scope 3 emission intensity by 97% by 2050. Facilitating the shift to next generation propellants is a key strategic priority for Bespak, with 75% of its Scope 3 decarbonisation potential directly linked to the transition. Focusing initially on the most emission-intensive areas of its carbon footprint, such as the use-phase of sold products, purchase of capital goods and services, and upstream transportation and distribution, Bespak is prioritising data-driven strategies and targeted engagement with the wider supply network to achieve these targets. As of 2025, landfill avoidance remained a consistent strength despite operational growth. Bespak maintained its near-zero waste-to-landfill and 82% recycling rate, demonstrating its continued progress towards a circular resource economy. We also reported a 20% reduction in Scope 3 upstream emission intensity compared to the 2023 baseline. Although significant achievements, this is just the beginning – sustainability requires looking beyond the propellant transition
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and embedding sustainable business practices into the fabric of all operations, from material choice to packaging configurations and transport logistics. Following the publication of its first biodiversity report, Bespak is holistically assessing the ecological impact of its sites and the wider supply chain to enable the conscious implementation of initiatives reducing environmental impact. Additionally, as part of its strategic roadmap, Bespak developed a sustainability charter to help align and formalise carbon reduction objectives across the value chain. Requiring credible decarbonisation and compliance commitments from suppliers, the charter sets out clear expectations for responsible sourcing, communication, and transparent reporting to help monitor collective progress towards whole-network decarbonisation. Bespak is committed to delivering on its sustainability pledge as it grows responsibly in line with increasing global demand and is working to drive long-term positive change that empowers and enriches its customers, workforce and the local community.
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REFERENCES 1.
NHS (2020). Delivering a ‘Net Zero’ National Health Service
Louise Righton Louise Righton is Head of Strategic Marketing at Bespak. She has worked in the pMDI industry for more than 20 years in global marketing, commercial and government affairs roles. A graduate in Industrial Management, a Chartered Marketer and Fellow of the Chartered Institute of Marketing, Louise also holds a Master's degree in Strategic Marketing Leadership. She is a Board member at IPAC (International Pharmaceutical Aerosol Consortium) and is committed to leading the change to sustainable pMDIs.
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GREEN VISION The Sustainability Challenge in Advanced Therapy Manufacturing Advanced therapies are reshaping the treatment landscape, offering curative potential for conditions once managed only symptomatically. Gene therapies, gene modified cell therapies, mRNA medicines, and DNA based vaccines are moving steadily toward broader clinical and commercial use. Yet as these modalities scale, it has become increasingly evident that their manufacturing processes are not built for sustainability. Notably, it was estimated that the healthcare sector was responsible for 4% of global carbon dioxide (CO2) emissions in 2023, with projections suggesting a more than threefold increase by 2050 if no mitigative action is taken.1 This trajectory is incompatible with global climate goals and with the industry’s own commitments to environmental responsibility. While traditional biologics manufacturing has made progress through decades of process optimisation, advanced therapies which are still early in their industrial maturation, face steeper hurdles. Advanced therapies also face an unprecedented scale challenge. AAV gene therapies delivered systemically may require doses as high as 1×10¹⁷ viral genomes per patient, a level that places extraordinary pressure on upstream DNA supply and manufacturing infrastructure. As more programs move toward late stage development, the resource intensity of producing these materials, particularly plasmid DNA (pDNA), becomes a defining constraint on both sustainability and commercial viability. The Environmental Burden of Fermentation-Based DNA Production Fermentation has been the backbone of plasmid DNA production for decades. Its scientific foundations are well established, but there are substantial environmental and operational drawbacks. For example, fermentation requires large bioreactors, extensive water use, and significant energy inputs. Cleaning in place (CIP) operations alone consume vast quantities of water and chemicals. Even with the adoption of single use systems in some facilities, most pDNA is still produced in stainless steel reactors that demand intensive cleaning cycles. Additionally, fermentation generates considerable biomass and impurity loads. Clarified lysates typically contain less than 3% pDNA, so the majority of material entering purification is waste, for example RNA, genomic DNA, host cell proteins, endotoxins, and other processrelated impurities.2 Removing these impurities requires multiple chromatography steps, solvents, and filtration operations, each contributing to environmental impact. There are also safety challenges associated with fermentation-based DNA production. Since fermentation
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relies on bacterial hosts, pDNA can carry unwanted bacterial sequences, antibiotic-resistance markers, and endotoxins. These impurities must be removed, further adding to the resource burden, and underscoring both environmental and public-health concerns. Furthermore, fermentation struggles to scale efficiently, especially for complex plasmids containing high GC content, inverted terminal repeats, or unstable motifs. Yields vary widely, sometimes by orders of magnitude, which makes production unpredictable and resource intensive. Even with careful control of critical process parameters such as agitation, pH, and temperature, achieving high percentages of supercoiled DNA remains challenging. These limitations collectively increase the cost of goods, slow production timelines, and inflate environmental impact. As advanced therapies move toward commercial scale, fermentation’s inefficiencies become increasingly untenable. A further sustainability challenge lies in the inherent variability of fermentation yields. Plasmid productivity can fluctuate by one to two orders of magnitude depending on sequence complexity, meaning that facilities must routinely overallocate water, media, and energy to compensate for unpredictable output. This variability forces manufacturers to operate with excess capacity and safety margins, inflating the environmental footprint even when batches ultimately meet specifications. The Unique Challenge of Advanced Therapies Advanced therapies differ from traditional biologics in several ways that amplify sustainability concerns. For example, manufacturing gene therapies, viral vectors, and nucleic acid-based medicines often requires more complex processes and larger quantities of critical raw materials. This cost concentration reflects both the importance and inefficiency of current DNA production methods. Unlike monoclonal antibodies, which benefit from decades of optimisation, advanced therapy manufacturing platforms are still evolving. Many processes remain bespoke, manual, or poorly standardised. This immaturity limits opportunities for
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energy efficient equipment, waste reduction strategies, and green chemistry principles.
upstream volume translates directly into lower water, energy, and waste.
Supply chain fragility adds another layer of complexity. Long lead times for GMP grade pDNA, limited global manufacturing capacity, and batch to batch inconsistency create bottlenecks that ripple through entire development programmes. These constraints often force manufacturers to stockpile materials or run facilities at suboptimal utilisation rates, both of which increase waste and energy consumption. As demand for genetic medicines grows, these inefficiencies become increasingly difficult to absorb.
Comparative analyses have shown that enzymatic DNA production typically uses around 65% less water than pDNA fermentation processes and up to 81% less when compared with low-productivity fermentation.3 Furthermore, enzymatic processes do not involve bacterial biomass so cleaning requirements are minimal, further widening the sustainability gap.
As advanced therapies expand into larger patient populations, cost and sustainability become commercial imperatives. High manufacturing costs threaten accessibility, while high environmental impact threatens long-term viability. The industry is increasingly recognising that sustainability is not optional, but a prerequisite for scale. Enzymatic DNA Production: A More Sustainable Alternative To address the sustainability challenges of fermentation, enzymatic DNA synthesis has emerged as a promising alternative. Enzymatic methods produce DNA in vitro, without bacterial cells, dramatically reducing resource consumption and simplifying purification. It operates at small volumes and avoids the need for large bioreactors. Notably, enzymatic processes can achieve equivalent yields, operating at scales smaller than 5 litres, compared with fermentation volumes of over 50 litres, sometimes as high as 300 litres. This reduction in
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Enzymatic DNA production is significantly faster, with the potential for a GMP batch to be completed in just five days, compared with three weeks using fermentationbased production. Shorter production cycles reduce energy consumption and improve responsiveness to clinical and commercial demand. Moreover, enzymatic DNA production also benefits from tighter process control. Because amplification occurs in a defined, cell free environment, critical parameters such as reaction kinetics, and enzyme activity can be precisely managed. This level of control reduces batch failures and rework—two major contributors to unnecessary resource consumption in fermentation based systems. Fewer failed batches mean fewer discarded materials, less energy use, and more predictable planning for downstream operations. Sustainability Gains in AAV Manufacturing Cell free DNA technologies also reshape the sustainability
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GREEN VISION profile of adeno-associated virus (AAV) manufacturing specifically by reducing the material intensity of the process itself. In conventional transient transfection workflows, pDNA and transfection reagents represent two of the most resource heavy inputs. Analysis has shown that DNA alone can account for up to 40% of AAV batch costs, a figure that reflects not only financial burden but also the upstream environmental load associated with bacterial fermentation, media preparation, and waste handling.4
and eliminate the need for viral delivery systems, reducing both cost and environmental impact. Specialised enzymatic DNA templates can streamline mRNA production, improving fidelity and reducing resource consumption.
By enabling a 40–50% reduction in DNA and reagent usage, cell free DNA directly lowers the volume of chemicals, consumables, and packaging materials required for each batch.
Conclusion: Building a Sustainable Future for Genetic Medicines Traditional fermentation-based DNA production is misaligned with the environmental and economic realities of scaling advanced therapies. Enzymatic DNA synthesis offers a compelling alternative: faster, cleaner, more efficient, and better suited to the complexity of modern genetic constructs. The industry is beginning to recognise that sustainability is inseparable from scalability, and that upstream innovation is essential to building a resilient manufacturing foundation.
Reducing DNA and reagent inputs also improves facility utilisation. When upstream steps require fewer materials, production lines can operate more efficiently, with shorter turnaround times and reduced dependence on large volume equipment. This shift enables manufacturers to produce more doses per square metre of facility space, lowering the per dose environmental footprint and reducing the need for capital intensive expansions. Downstream Sustainability Benefits Improving upstream DNA production has ripple effects across the entire advanced therapy manufacturing chain. For example, higher-purity DNA can improve viral vector packaging efficiency, reducing the amount of DNA required per batch and increasing dose output. Packaging efficiency can be doubled on average, enabling more sustainable vector production.5 Further Gains in Non-viral Therapies Enzymatically produced DNA supports the formation of smaller, more uniform lipid nanoparticles (LNPs) without compromising encapsulation efficiency. Smaller LNPs may reduce raw material use and improve biodistribution. Additionally, high-purity, closed linear DNA constructs can improve editing efficiency
Collectively, these downstream benefits demonstrate that sustainable DNA production can strengthen the entire advanced therapy ecosystem.
Advanced therapies promise transformative benefits for patients. Ensuring that their production is equally transformative for the planet is the next critical step. By rethinking DNA manufacturing today, the sector can build a more sustainable, accessible, and scalable future for genetic medicines. REFERENCES 1. 2. 3. 4.
5.
Howarth, Tom. – The green chemistry startup disrupting pharmaceuticals. GreenBiz. 8 May 2023. Carnes, Aaron E. and James A. Williams. - Low Metabolic Burden Plasmid Production. Gen. Eng. News. 1 Mar. 2009. Synthetic dbDNA™ delivers a sustainable future for genetic medicines. Touchlight. 2025 Synthetic dbDNA™ delivers a sustainable future for genetic medicines. Touchlight. 2025 Unlocking AAV gene therapy cost of goods savings with dbDNA™: A comparative analysis with plasmid DNA. Touchlight. 2026 Synthetic dbDNA™ delivers a sustainable future for genetic medicines. Touchlight. 2025
Jill Makin Dr. Jill Makin is Chief Scientific Officer at Touchlight, where she has played a pivotal role in establishing the company as a leader in enzymatic DNA manufacturing. Since joining in 2012, she has led the scientific development and industrialisation of Touchlight's proprietary cell-free DNA technology, helping to transform it into a scalable GMP platform that supports the manufacture of DNA for a broad range of advanced therapeutic applications. Jill leads the company's scientific strategy, driving innovation in DNA technologies, manufacturing processes and product development. She works closely with biotechnology and pharmaceutical partners to enable the translation of groundbreaking genetic medicines, vaccines and cell therapies from early development through to clinical application. With extensive experience spanning biopharmaceutical R&D, she is committed to advancing manufacturing solutions that accelerate patient access to innovative treatments.
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GREEN VISION Insects’ Protein in Animal Nutrition: The Regulatory Landscape in the EU and US In recent years, growing concerns around the sustainability and environmental impact of conventional protein sources, combined with the need to secure sufficient protein supply to meet the increasing demand in a growing global population have driven significant interest in alternative proteins. When it comes to animal feed, one protein source attracting great scientific and commercial interest is insect protein. Insects offer a combination of nutritional quality, production efficiency and environmental sustainability that sets them apart from other alternatives. From a nutritional standpoint, insects are a rich source of high-quality and digestible protein. From a production standpoint, insects are efficient converters of organic matter that require less land, water and feed than conventional livestock to produce an equivalent unit of protein. The recognition of insect protein’s potential has been reflected in policy over the past decade, with a series of regulations expanding the scope of its authorised use. Yet commercialisation of insect-derived ingredients in animal nutrition remains governed by a complex and still-evolving regulatory framework that varies considerably between jurisdictions. This article provides a structured overview of the current regulatory landscape in the two most relevant markets: the European Union (EU) and the United States (US). Regulatory Context in the European Union In the EU, the first insect-specific authorisation came in 2017 with Regulation (EU) No 2017/893 which permitted the use of processed animal proteins (PAPs) derived from insects in aquaculture feed.1 This was followed in 2021 with Regulation (EU) 2021/1372 which extended the authorisation of insect PAPs to poultry and pig feed, covering seven species: Hermetia illucens (black soldier fly), Musca domestica (common housefly), Tenebrio molitor (yellow mealworm), Alphitobius diaperinus (lesser mealworm), Acheta domesticus (house cricket), Gryllodes sigillatus (banded cricket) and Gryllus assimilis (Jamaican field cricket).2 Shortly after, Regulation (EU) 2021/1925 added Bombyx mori (silkworm) to the list, bringing to eight the total number of authorised species for insect PAPs.3 These authorisations finally opened the market for insect protein in animal feeds, but they do not stand alone. They are embedded within a broad regulatory architecture governing all animal feed in the EU that applies to insect PAPs directly and indirectly. Other horizontal EU regulations are applicable to the insect feed sector. Regulation (EC) No 178/2002, the General Food Law,
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constitutes the overarching legal framework, establishing the fundamental principles and general requirements governing food and feed safety.4 The hygiene and safety standards for feed production are laid down in Regulation (EC) No 183/2005.5 This regulation requires insect producers placing products on the feed market to be registered or approved as feed business operators and implement appropriate hygiene procedures. Furthermore, Regulation (EC) No 767/2009 governs the placing on the market and use of feed in the European Union, covering aspects such as labelling, presentation and claims made for insect-derived feed materials.6 TSE Framework A particularly significant law for the insect protein sector is Regulation (EC) No 999/2001, which for many years represented the biggest regulatory barrier to the use of insectderived ingredients in animal feed. 7 Originally adopted to prevent, control and eradicate transmissible spongiform encephalopathies (TSEs), this regulation established a broad feed ban on processed animal proteins (PAPs) for all farmed animals. Under this ban, insects along with other PAPs, were not permitted for use in feed for food-producing animals. Based on the scientific assessment of the European Food Safety Authority (EFSA) , which confirmed that insects do not present a TSEs risk, the restrictions were progressively lifted with the amendments to Reg. 999/2001, first lifting the ban for insect PAPs in aquaculture feed through Reg. 2017/893, and subsequently extending this derogation to poultry and pig feed through Reg. 2021/1372.8 The ban has not been fully lifted, as insect PAPs remain prohibited in feed for ruminants and the feeding of insects with blood products or proteins from ruminants continues to be prohibited by this regulation.
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GREEN VISION Animal By-Product Legislation Another central element of the regulatory framework for insects are the laws on Animal by-products (ABPs), Regulation (EC) No 1069/2009 and its implementing Regulation (EU) No 142/2011, which establishes the health rules regarding ABPs and derived products.9,10 These regulations directly affect insect production: Article 3(5) of Reg.1069/2009 defines any vertebrate or invertebrate as an ‘animal,’ and Article 3(6) establishes that a ‘farmed animal,’ includes any animal kept for food production or other farming purposes, thereby formally bringing insect producers within the scope of EU farm animal legislation. Under this framework, insect-derived products are treated as ABPs, subject to processing, traceability and establishment approval requirements. In the case of using insects for pets, animals raised for fur and zoo animals, since these animals do not enter the human food chain, the biosafety concern is removed. For pet food, Article 35 defines the eligible materials from which pet food may be derived, within which Article 10(l) insect-derived ingredients fall as ‘products of terrestrial invertebrates.’ For fur and zoo animals, Article 18(1) of the same regulation provides a derogation from the standard rules of ABPs in farmed animal feed. A regulatory constraint for insect production is the substrates that may be used for insect rearing. On one hand, Reg. 767/2009 requires that feed must not consist of any material prohibited under the list provided in the Annex III of the same regulation. On the other hand, Reg. 142/2011 establishes the raw material requirements for PAPs derived from farmed insects, including the permitted substrate list and the explicit prohibition on manure, catering waste and other waste.11 These restrictions, while based on biosafety principles, reduce the practical implementation of circular economy models in insect production. It is worth noting that these substrates rules apply to insects reared for PAPs, but no equivalent list exists for use as live insects, which are approved feed materials as specified in the next section. Catalogue of Feed Materials The formal inclusion of insect-derived ingredients as feed materials is stablished in Regulation (EU) No 68/2013 the EU Feed Material Catalogue. This catalogue is the official reference list of ingredients that are legally recognised for use in animal feed in the European Union. Four entries are directly relevant to insects and one specific to insect PAPs: •
Entry No 9.16.1 – Terrestrial invertebrates, live: Live terrestrial invertebrates, in all their life stages, other than species having adverse effects on plant, animals and human health.
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Entry No 9.16.2 – Terrestrial invertebrates, dead: Dead terrestrial invertebrates, other than species having adverse effects on plant, animals and human health, in all their life stages, with or without treatment but not processed as referred to in Regulation (EC) No 1069/2009.
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Entry No 9.4.1 – Processed animal protein: Product obtained by heating, drying and grinding whole or parts of land animals, including invertebrates in all their life stages from which the fat may have been partially extracted or physically removed.
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Entry No 9.2.1 – Animal fat: Product composed of fat from land animals, including invertebrates other than species pathogenic to humans and animals in all their life stages.
Regulatory Context in the US The regulatory context in the US differs greatly from that of the EU, both in the structure of the legal framework and in the routes available to obtain market authorisation for new feed ingredients. Under the Federal Food, Drug and Cosmetic Act (FD&C Act) animal feeds are classified as food and any ingredient must meet one of the three conditions: approval as a food additive under a Food Additive Petition (FAP), the recognition as Generally Recognised as Safe (GRAS) under 21 CFR Part 570 and 582, or the listing as a defined ingredient in the official publication (OP) of the Association of American Feed Control Officials (AAFCO).12,13,14 AAFCO is a voluntary membership organisation that has maintained the AAFCO OP since 1920. The OP contains a comprehensive list of animal food ingredients. Most states adopt the ingredient definitions under their state laws, facilitating the marketing of animal food ingredients. Another relevant regulation is the Food Safety Modernisation Act, a milestone in the preventive approach towards food safety in the US.16 Its section 21 CFR Part 507 on current good manufacturing practice, hazard analysis and risk-based preventive controls for food for animals, requires all food and feed manufacturers, including insect producers, to proactively identify hazards and implement preventive controls.17 The first approved insect-ingredient arrived in 2016, with the AAFCO definition of Hermetia illucens (dried black soldier fly larvae - BSFL) as a feed ingredient for feeding of salmonid fish. In 2018 the definition was reviewed to include poultry, in 2019 to include swine and in 2021 to include adult dogs. In 2022, three new definitions were incorporated such as dried whole BSFL, partially defatted BSFL meal, and BSFL oil for use in finfish, poultry, swine, adult dogs and adult cats. Only in 2024 the AAFCO approved a new insect species with the definition for dried Tenebrio molitor (yellow mealworm) meal for adult dogs, the second to receive an AAFCO definition. AFIC and SRIS: New Pathways Insect-derived ingredients have been introduced in the US via AAFCO listing so far, however a significant structural change occurred in October 2024, when the memorandum of understanding (MOU) between FDA and AAFCO, under which FDA provided scientific review support for the AAFCO ingredient definition process, expired ending so the most common route that the industry had to bring insects to the market. In October 2024, the FDA published the Guidance for Industry (GFI) #293 confirming they do not intend to initiate enforcement action with respect to the food additive approval requirements of the FD&C Act for ingredients listed in chapter six of the 2024 AAFCO Official Publication.18 This meant that BSFL and mealworm definitions in the 2024 OP retain their regulatory standing under federal law. As an alternative to the previous MOU, in January 2025 the FDA published GFI #294 stablishing the Animal Food Ingredient Consultation (AFIC) as the new interim pathway for companies seeking FDA input on novel
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GREEN VISION
animal food ingredients, this is therefore the primary route for new insect species seeking regulatory recognition in the US.19
following the establishment of two new review pathways SRIS and AFIC.
In parallel, AAFCO established a new independent review pathway through a partnership with Kansas State University's Olathe Innovation Campus. This new pathway was introduced to offer a fast and accurate scientific assessment of new animal food ingredients, currently known as the Scientific Review of Ingredient Submissions (SRIS).20 Submissions are evaluated by experts specifically recruited across the country, according to the FDA GRAS framework, and approved definitions are incorporated into the AAFCO Official Publication. SRIS represents a practical pathway for insect companies seeking to introduce new species or products into the US market.
The market for insects is opening and it comes with uncertainty and opportunities, however they could become a new staple ingredient in sustainable in animal nutrition. Understanding these frameworks will be essential for industry and feed formulators seeking to navigate the opportunities of this emerging sector.
Both pathways end in the listing of a non-proprietary AAFCO definition, but each of them offers advantages and limitations. AFIC represents a recognition at the federal level, with direct FDA involvement and does not require pivotal safety data to be in the public domain. SRIS, on the other hand, does not incorporate an FDA review, operates on the basis of an independent GRAS conclusion, which requires that peer-reviewed safety data is available in the public domain, delaying the process if the information has not already gone through the publishing step and potentially limiting the ability of companies to protect sensitive information. The treatment of information also differs: AFIC publishes a public notice of the consultation filing, containing the company name, substance, date and intended use, while SRIS dossiers are not subject to Freedom of Information requests, providing greater confidentiality during the process (a summary of the expert panel findings will be published only towards the end of the process, when scheduled for discussion by the AAFCO Ingredient Definitions Committee). Finally, the two pathways differ in terms of cost and timeline. SRIS operates on a fee-based model and offers a defined review timeline of approximately nine months. The AFIC consultation does not involve a fee but does not provide a fixed review timeline. The choice between these pathways therefore depends on the nature of the data, the tolerance for public disclosure and the need for timing certainty. Conclusion The regulatory framework governing the use of insects in animal nutrition has evolved considerably over the past decade in both the EU and the US, yet the two systems remain structurally different. The EU has built a more comprehensive, species-specific that requires legislative action for the addition of new species, while the US has relied on a submission-driven, ingredient-by-ingredient process that delivered an earlier feed approval in 2016, but that currently only covers two fully authorised species while undergoing significant changes
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REFERENCES 1. 2. 3. 4. 5. 6. 7. 8.
http://data.europa.eu/eli/reg/2017/893/oj http://data.europa.eu/eli/reg/2021/1372/oj https://eur-lex.europa.eu/eli/reg/2021/1925 http://data.europa.eu/eli/reg/2002/178/2026-01-01 http://data.europa.eu/eli/reg/2005/183/oj http://data.europa.eu/eli/reg/2009/767/oj http://data.europa.eu/eli/reg/2001/999/oj Risk profile related to production and consumption of insects as food and feed https://doi.org/10.2903/j.efsa.2015.4257 9. http://data.europa.eu/eli/reg/2009/1069/oj 10. http://data.europa.eu/eli/reg/2011/142/2025-10-29 11. Regulation (EU) No 142/2011, Annex X, Chapter II, Section 1 12. https://www.fda.gov/regulatory-information/laws-enforcedfda/federal-food-drug-and-cosmetic-act-fdc-act 13. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/ part-570 14. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/ part-582 15. https://www.aafco.org/ 16. https://www.fda.gov/food/food-safety-modernization-actfsma/full-text-food-safety-modernization-act-fsma 17. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/ part-507 18. https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/cvm-gfi-293-fdaenforcement-policy-aafco-defined-animal-feed-ingredients 19. https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/cvm-gfi-294-animal-foodingredient-consultation-afic 20. https://sris.k-state.edu/
Daniel Pagés Daniel Pagés is graduated in veterinary medicine and specialises in regulatory science for animal nutrition. He is part of Argenta's feed and food regulatory affairs team, providing support in navigating complex approval pathways and regulatory frameworks. Previously, he worked at the European Food Safety Authority (EFSA) where he participated in the risk assessment of additives and products used in animal feed.
2026
GREEN VISION Breathing New Life into pMDIs: Pharma’s Sustainability Drive The pharmaceutical industry is in the midst of a green revolution, with a growing emphasis on sustainability and environmentally conscious manufacturing. A key area of focus for this shift is the development of pulmonary and nasal drug delivery devices. For decades, pressurised metered-dose inhalers (pMDIs) have been a cornerstone of respiratory therapy, but the propellants that power them are under legislative scrutiny for their environmental impact. The change is driven by global and national regulations across Europe, the U.K. and U.S. stemming from the Kigali Amendment to the Montreal Protocol. This mandates a phasedown of the current generation of high global warming potential (GWP) hydrofluorocarbons (HFCs) to 85% of present levels in terms of tonnes of CO2 equivalent. Building on this, the E.U. in particular has included a phaseout of HFCs by 2050 in its own regulations written to achieve the goals of the Amendment. As these legislative changes come into effect worldwide, they are driving a period of focused innovation in inhalation drug development. Pharmaceutical companies must now reformulate their products to remain efficacious for patients, compliant with new regulations and sustainable for the planet. This challenge requires a fundamental re-evaluation of the pMDI as an entire system, from its formulation and device components to its manufacturing. This industry-wide shift, propelled by an evolving regulatory landscape and a shared commitment to sustainability, presents significant technical hurdles. In the following article, Andy Burns, Vice President of MDI Business Development at Kindeva, will explore these challenges, the pivotal role expert contract development and manufacturing organisation (CDMO) partners play in navigating the transition, and what these vital changes mean for the future of sustainable respiratory drug delivery.
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European legislation: The E.U.’s updated F-Gas Regulation (EU 2024/573), which took effect in March 2024, is a primary driver. It accelerates the HFC phasedown and will eventually remove the previous medical-use exemption for pMDIs.2
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U.K. legislation: Post-Brexit, the U.K. has retained and continues to enforce its own F-gas regulations, which align with the goals of the Kigali Amendment, pushing the industry toward lower-GWP alternatives.3 •
U.S. legislation: The American Innovation and Manufacturing (AIM) Act directs the Environmental Protection Agency (EPA) to phase down HFCs in line with the Kigali schedule. The EPA is now establishing a framework for this transition, which includes managing HFCs for essential uses like pMDIs while encouraging the shift to next-generation technologies.4
The Global Mandate for Greener Propellants The driving force behind the transition to greener propellants is the Kigali Amendment to the Montreal Protocol. This global agreement compels signatory nations to phase down the production and consumption of HFCs, such as HFA 134a and HFA 227, which are potent greenhouse gases with high GWP. The agreement sets an ambitious schedule, requiring a first group of nations (including the U.S., U.K. and all E.U. member states) to achieve an 85% phasedown by 2036.1
To understand the drive for change, it is crucial to consider the scale of the impact. The use of a single traditional pMDI can have a carbon footprint equivalent to a car journey of over 100 miles.5 This stems from the high GWP of HFC propellants, which contribute disproportionately to global warming when released into the atmosphere. For pharmaceutical companies, the implications are clear: to keep pMDI products on the market, they must find and validate lower-GWP next-generation propellants (NGPs) to replace traditional gases, and reformulate their products to be both safe and efficacious.
This international treaty is now being implemented through national and regional laws:
Navigating Next-generation Propellants Finding a replacement for established HFCs in pMDIs is far
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GREEN VISION more than a simple one-for-one swap of the propellant gas as it would be in non-pharmaceutical applications, such as in Heating, Ventilation, and Air Conditioning (HVAC) systems. This transition presents a unique set of technical challenges, including: •
Compatibility with pMDI devices: The new propellant must be chemically and physically compatible with all device components, from the metal canister to the elastomer valve seals. This includes a thorough assessment of extractables and leachables (E&L) to ensure the propellant's unique properties do not introduce new impurities that could compromise the stability of the formulation.
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Compatibility with drug formulations: The propellant is a critical part of the drug formulation itself. It must be compatible with the active pharmaceutical ingredient (API) and any excipients, ensuring the drug remains stable and deliverable over the product's shelf life.
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Patient safety: Any new propellant must undergo rigorous toxicological testing to prove it is safe for inhalation. This safety assessment must also extend to any new compounds identified during compatibility testing, ensuring the final delivered dose is free from potentially harmful impurities.
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Administration performance: The reformulated product must demonstrate bioequivalence to the original, meaning it delivers the same therapeutic effect to the patient. This requires extensive testing to ensure metrics like particle size and plume geometry result in the correct drug deposition in the lungs.
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Manufacturing and safety: While leading candidates like HFA-152a are classified as flammable, this is a manageable engineering challenge. It is addressed through the implementation of expert safety protocols and the use of specialised, ATEX-compliant manufacturing facilities.
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Regulatory approval: Switching of a propellant will require a thorough assessment and approval by regulatory authorities, necessitating the generation and submission of a comprehensive package of technical and potentially even clinical data on the reformulated product.
The industry's search has narrowed to two primary low-GWP NGP candidates: HFA-152a from fluor and energy materials specialist, Orbia; and HFO-1234ze from advanced materials provider, Honeywell. Both offer environmental benefits, and have potential as near-term solutions for reformulating many existing pMDI products. The choice comes down to a trade-off between formulation science and key factors like manufacturing safety and environmental performance. HFO-1234ze has an exceptionally low GWP and is non-flammable, but its chemical properties may make it a poor solvent for some respiratory drugs, creating challenges with reformulation particularly for solution formulations. In contrast, HFA-152a has a higher GWP and is flammable, but is also chemically more similar to the currently used HFA-134a, which may provide a more direct pathway to achieving a stable and effective product.
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Who’s Propelling the Transition to NGPs? The scale and complexity of the propellant transition mean that many pharmaceutical companies will turn to expert partners for support. A CDMO with specialised expertise in inhalation and sustainable propellants can significantly de-risk and accelerate the transition to NGPs. An expert CDMO offers several key advantages: •
Legacy of inhaled innovation: A long history of formulating and developing complex inhalation products provides the scientific foundation needed to tackle reformulation challenges.
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Purpose-built infrastructure: A proactive CDMO partner will have already invested in the specialised infrastructure needed to safely handle flammable propellants like HFA-152a. This saves pharmaceutical companies significant time and capital expenditure, removing a major barrier to entry.
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Regulatory expertise: Decades of experience in bringing inhalation products to market provides the regulatory insight needed to navigate the complex filing process for reformulated pMDI products across global agencies.
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Integrated combination product development: A pMDI is a combination product, and its success depends on the seamless integration of the drug formulation, the componentry and the device. A CDMO with in-house expertise in both areas can co-optimise the entire system, ensuring consistent, effective drug delivery while accelerating the overall development timeline.
Successfully integrating this deep scientific knowledge, regulatory insight and application-specific infrastructure is where an experienced partner becomes essential. Kindeva brings a legacy of pMDI innovation that stretches from inventing the world's first pMDI in 1956 to leading the industry's last major environmental shift with the first CFC-free inhaler. This deep heritage, particularly the expertise gained during that first propellant transition, provides an unmatched understanding of the intricate interplay between formulation, device and manufacturing. Today, this expertise is focused on the next generation of sustainable inhalers, with significant investment in new commercial-scale manufacturing lines to support the transition to green propellants. Greener Tomorrows Are in the Making The mandated phasedown of high-GWP propellants marks a pivotal moment for respiratory medicine. The journey is not merely about compliance but about fundamentally re-engineering a cost-effective, critical and patient-preferred drug delivery platform for a sustainable future. The pMDI platform remains the ideal pulmonary platform from a cost-efficiency point of view, so it is essential to address this propellant issue as quickly as possible. While the transition to NGPs presents significant technical and manufacturing challenges, it is also a powerful catalyst for innovation. This transition is driving innovation across the entire pMDI system, demanding a more integrated approach
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to formulation, device compatibility and manufacturing. The long-term impact of this shift will be substantial. It will dramatically reduce the carbon footprint of these inhaled therapeutics and align the pharmaceutical industry with global climate goals. Most importantly, this will be accomplished without sacrificing the high standards of patient safety and efficacy that have made pMDIs a cornerstone of respiratory care. Successfully navigating this complex landscape requires both deep technical capability and a new level of collaboration. The journey to the next generation of pMDIs will be built on strategic partnerships between pharmaceutical innovators and experienced CDMOs who have the scientific legacy and the purpose-built infrastructure to turn these new propellants into approved, life-sustaining products. This shared commitment is both a regulatory necessity and the foundation for the future of sustainable respiratory care. REFERENCES 1.
Explanatory memorandum on the Kigali Amendment to the Montreal Protocol on substances that deplete the ozone layer, Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer
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3. 4. 5.
Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014, Official Journal of the European Union Fluorinated gas (F gas): guidance for users, producers and traders, UK Government Protecting Our Climate by Reducing Use of HFCs, United States Environmental Protection Agency Asthma inhalers and climate change. What is this decision aid about? National Institute for Health and Care Excellence
Andy Burns Andy is the Vice President of Business Development for the MDI (Metered Dose Inhaler) platform and also is a member of the Senior Leadership Team (SLT) of Kindeva , He has been with the company since its inception in 2020 and is responsible for driving growth activity in the MDI space, with particular focus on transitioning the current portfolio of products to more sustainable and lower-GWP (Global Warming Potential) alternatives being phased into the market over the coming years.
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