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CONTENTS 04 FOREWORD GREEN VISION 06 Revolutionising Sustainability in Biotech & Pharma with My Green Lab’s Initiatives As a result of the urgent need to address the environmental impacts of the scientific industry grows, Namrata Jain of My Green Lab explains their mission to build a global culture of sustainability in science. She discusses providing tools and resources to help the industry move towards sustainability and inevitably the end of goal of net zero by 2025.

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MANAGING DIRECTOR Mark A. Barker BUSINESS DEVELOPMENT Anthony Stewart anthony@senglobalcoms.com Mark A. Barker mark@senglobalcoms.com EDITORIAL MANAGER Beatriz Romao beatriz@senglobalcoms.com DESIGNER Jana Sukenikova www.fanahshapeless.com

Embracing Sustainable Initiatives in the Pharmaceutical Supply Chain

Sustainability is sometimes perceived as a source of risk rather than an opportunity as there is arguably contradiction between supply chain resilience and sustainability. However, the belief that these two elements are mutually exclusive overlooks the potential for symbiotic growth opportunities. Will Robinson of LogiPharma explains that, by aligning sustainability practices with resilience strategies, companies can not only mitigate risks but also unlock avenues for sustainable innovation.

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Insights from Owen Mumford: Life Cycle Assessment for Drug Delivery Devices

The burden of carbon emissions from the healthcare sector is well documented and sees the industry responsible for around 5% of global emissions. Oli Gould of Owen Mumford focuses on the importance of building a life cycle assessment tool that brings sustainable decision making to the forefront for new designs, while also considering the challenges of improving sustainability without compromising product usability and safety that comes with doing so.

RESEARCH & CIRCULATION MANAGER Virginia Toteva virginia@senglobalcoms.com ADMINISTRATOR Barbara Lasco FRONT COVER istockphoto PUBLISHED BY Senglobal Ltd. Unite 5.02, E1 Studios, 7 Whitechapel Road, E1 1DU, United Kingdom Tel: +44 (0) 2045417569 Email: info@senglobalcoms.com www.pharmanaturepositive.com

Pharma Nature Positive is published bi-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 3 Issue 1 2024 Senglobal Ltd.

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CONTENTS

20 Driving Sustainable Manufacturing Forward

32 Sustainability Efforts at Aurena

In today’s world, where the threat of climate change looms large, the pursuit of sustainable practices in the pharmaceutical industry isn’t just a trend – it’s a necessity. WuXi STA (CRDMO) are investing in carbon footprint reduction, driving innovative breakthroughs, and aligning our scientific advancements with a vision of health and sustainability for everyone.

Aurena Laboratories is seeking to obtain all electricity from renewable sources by 2030. The company has made a commitment to sustainability, and ensures that their focus on social, environmental and economic sustainability goals corresponds with the expectations of stakeholders. Aurena, highlights the ways in which the company is making efforts to create a greener future.

22 SÜDPACK MEDICA Offers Innovative Solutions for the Pharmaceutical Industry

36 Committing to Sustainability

Life science organisations can take the first steps to sustainability by converting to renewable energies, using e-mobility and utilising smaller secondary packaging for their products. Despite this, strict regulations regarding product packaging complicate the implementation of these measures. SÜDPACK MEDICA, states how the company has developed a tool to analyse and optimise the environmental impact of packaging solutions, to find a more sustainable packaging concept.

24 Understanding the Corporate Sustainability Reporting Directive in Europe and Its Implications for Medium-sized Companies

“We put patients first”. Nemera delve into how they prioritise the safety of people, by setting a goal to reduce their carbon footprint in both production and supply chain processes. They recognise the importance of reducing the negative impacts of their approaches and explain their commitment to embedding sustainability, not only into processes, but also into mindset.

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Small and medium-sized enterprises (SME) are companies which typically have an employee count of around 250–1000 people.

There is a call to action for SMEs to evaluate their sustainability efforts. Michael Gorek at Richter-BioLogics explains how the company has addressed challenges to contribute to a greener future, by integrating sustainability into their operations to drive a positive impact on the environment.

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CPHI Worldwide 2024

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Nemera

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28 Pharmaceutical Packaging and the Plastic Dilemma: Can PCR Materials Make a Difference?

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Owen Mumford

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Richter Biologics

The pharmaceutical industry uses plastic due to its wide variety of uses, sterility and durability properties. However, the pharmaceutical industry must find more eco-friendly alternatives to the usage of plastic within its primary and secondary packaging. Steve BrownettGale of Origin delves into the benefits and challenges of using preconsumer regrind (PCR) materials as a solution to minimise the environmental footprint.

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SÜDPACK

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Volume 3 Issue 1

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FOREWORD With sustainability targets becoming a central focus for so many Pharma organisations, finding innovative solutions to support them is essential.

Pharmaceutical companies, like many other sectors, will be concerned about new regulations for reporting carbon emissions. Non-compliance can result in fines, tarnishing a company’s reputation and impacting it financially.

The Science Based Targets Initiative’s (SBTi’s) Corporate Net-Zero Standard has been created, not only to help companies achieve sustainability goals, but to provide a robust, science-based understanding of net-zero.

So it’s no surprise that more and more companies globally have made net-zero pledges, now reportedly covering 88% of emissions worldwide. As of today, well over half of the world’s largest 2,000 publicly listed companies have either pledged or incorporated net-zero targets within their corporate strategy, with a small percentage having already achieved them.

This sounds positive, but bear in mind we’re at the beginning of the journey and the path to get there has been interpreted in different ways.

The Pharma supply chain is a vast and complex. Other than packaging, companies aiming for ambitious net-zero targets could consider efficiencies which reduce transportationrelated emissions, responsible procurement practices and effective sharing of information with stakeholders within the supply chain.

Whether it’s for meeting sustainability goals, implementing cutting-edge technologies, or accelerating drug approval timelines, collaboration across the pharmaceutical supply and value chain is no longer just a want – it is a need.

Generative AI, machine learning, and digital futures: The rapid rise of generative AI models, machine-learning algorithms, and large language models such as Chat GPT will push pharmaceutical operations beyond current capabilities. Data-oriented manufacturing and Big Data Analytics for regulatory compliance will have a significant impact on all pharma players.

Reaching sustainability goals across the pharmaceutical supply chain remains a constant conversation within the industry. In 2024, discussions will focus on the management of difficult-to-quantify scope 3 emissions, new regulations for pharma packaging, and how collaboration is a requirement for the dissemination of information and assessments across the industry.

Excipients are also continuing to see an explosion of interest in 2024. The FDA’s Novel Excipient Pilot Program will start to see the results of their efforts to accelerate approval for excipients.

Advancements in personalised medicines, multifunctional ingredients, and advanced therapeutics are also pushing drug manufacturers to look beyond existing excipients that are limiting the kinds of therapeutics available.

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There is an uptick in the adoption of advanced manufacturing technologies, leading to smaller batch sizes and a more adaptable manufacturing approach to cater to the demands of personalized medicine and clinical trials. Simultaneously, the increasing integration of digital technologies, automation and data analytics is expected to play a pivotal role. Moreover, continued industry investment in bolstering supply chain resilience post-Covid.

Additionally, increased regulatory adaptations and collaborations to keep pace with technological advancements and escalating costs. For example, consider the Mutual Recognition Agreement signed in July 2023 between Switzerland's SwissMedic and the USA's FDA, validates inspections conducted by each other's regulatory authorities.

Whilst it is essential to focus on patient disease management and providing safe, effective, high quality and well usable treatment options, pharma manufacturers and CDMOs must re-design the way they work, to ensure the sector is operating sustainably. My prediction (and hope) for 2024 is that the industry will focus on sustainability by: developing formulations and medicines with sustainability as one key criterion (beyond compliance, stability and usability); building lab and manufacturing operations that focus on energy efficiency and savings and considering quick wins (e.g., motion controls, energy controls, LEDs, waste reduction and management, implementation of circular solutions etc.); operating using self-generated (renewable) energy; focusing on research on alternative options for pharma, e.g., moving away from singleuse disposable plastics to biodegradable components or circular solutions. There is a lot to do and we have no time to wait until 2030, 2040 or 2050.

The life sciences market will continue to grow this year, driven by a strong pipeline in diabetes, weight loss and oncology treatments and an increased focus on Advanced Therapy Medicinal Products. With more products coming onto the market, pharma companies will need to adopt a flexible approach to manufacturing. In response to these dynamic marketplace shifts, solutions providers are delivering ‘facilities of the future’ that adhere to cost and schedules while meeting the highest safety standards. Additionally, this next generation of pharma facilities aspire for the highest sustainability certification. To achieve this, the entire project life cycle, from design and construction to operation must be considered. Best practice in this regard focuses on: Significant reductions (of at least 40%) in water use; On-site renewable energy generation, such as rooftop solar panels and use of electric boilers; Efficient LED lighting fixtures and less electric power use for lighting; Reduction strategies for embodied carbon used in construction materials (like concrete); Diverting on-site construction waste from landfills to recycling facilities. Sustainability is not just about making energy and water savings. These facilities of the future will also promote biodiversity through the delivery of pollinator gardens, vegetation projects and reforestation plans. These facilities are also people-centric spaces that promote employee well-being, empowering them to innovate and collaborate to fulfil their potential. Ultimately, this approach will attract top talent to enable scientific discovery, thus, the emerging treatments and therapies will be developed and delivered to patients, faster.

Mark A. Barker, Managing Director, Senglobal Ltd

Volume 3 Issue 1

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GREEN VISION Revolutionising Sustainability in Biotech & Pharma with My Green Lab’s Initiatives The biotechnology and pharmaceutical industry is a critical player in the global economy. It is currently valued around 1 Trillion USD in 2021 and projected to experience an annual growth rate of 13.9% from 2022 to 2030. While this sector drives economic prosperity and lifesaving innovation, it also comes along with significant economic impact. My Green Lab, a non-profit organisation with a mission to build a global culture of sustainability in science, provides tools and resources to help the industry move towards sustainability in response to this challenge. My Green Lab Certification provides a structured framework for laboratories to assess, improve, and certify their environmental performance. It is recognised as the international gold standard for lab certification and is a proven, scalable program that helps organisations achieve their sustainability goals by engaging scientists in a powerful, proven process supported by a global community of green lab leaders.

My Green Lab’s Partnership with UN Campaigns In recognition of the urgent need to address the environmental impact of the scientific industry, My Green Lab is recognised as a delivery partner in the Race to Zero campaign, a global movement mobilising governments, businesses, cities, and universities to achieve net-zero carbon emissions by 2050 or sooner.

In fact, My Green Lab certification was selected by the 2030 Breakthroughs campaign as a global goal for Pharma and Medtech. In addition to Net Zero targets the Breakthroughs campaign outlines measurable and achievable sector-specific goals for the short, medium, and long term that will drive decarbonisation across every sector of the global economy. This campaign outlines ‘Breakthrough Outcomes’, which are sector-specific tipping points indicating that system change is inevitable. Organisations committing to the Breakthrough campaigns must achieve these ‘Breakthrough Outcomes’ by 2030 at the latest.

The Breakthroughs campaign set a goal that 95% of Labs are My Green Lab Certified at the highest level by 2030, highlighting the program’s critical role in driving positive change and contributing to the global effort to address climate challenges within these critical sectors.

To further bolster these efforts, My Green Lab supports the United Nations (UN) High-Level Climate Champions team by providing a part-time secondee as the Global Health Sector Lead, which provides coordination and support to the health sector and its efforts towards climate change mitigation and resiliency.

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The 2023 Carbon Impact of Biotech & Pharma Report Since 2021 My Green Lab has produced a report each year aligned with the COP Conference, called the Carbon Impact of Biotech & Pharma report, a comprehensive assessment of the biotechnology and pharmaceutical sector's sustainability efforts. My Green Lab developed this report in partnership with Intercontinental Exchange (ICE) and was released during COP28 in Dubai in December 2023. The report shows good progress in the sector but also urges for faster efforts to meet the strict environmental standards set by international organisations.

Building on the foundations laid by My Green Lab's 2021 & 2022 Carbon Impact of Biotech & Pharma reports, the 2023 edition further provides an evaluation of the biotech and pharma value chains. Drawing data from 226 publicly listed and 147 privately held companies, the report not only quantifies carbon emissions but also identifies critical hotspots for positive change. It also serves as a benchmark for gauging progress towards the UNFCCC Race to Zero and the UNFCCC 2030 Breakthrough Outcomes campaign.

The 2023 Carbon Impact of Biotech & Pharma report reveals both commendable progress and critical challenges. While industry giants with substantial revenue streams have embraced zero carbon goals and are actively working to reduce Scope 1, 2, and 3 emissions, progress is still slow and largely confined to the top 25 largest companies.

Alarmingly, 90% of the 91 public companies analysed lack short-term targets aligned with the imperative 1.5°C increase goal, indicating a need to accelerate both target-setting and the ambition of corporate targets.

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Figure 1: My Green Lab Program Ecosystem

The comprehensive analysis further unveils that the industry's overall carbon impact has seen a steady rise, increasing from 3.9% in 2021 to 5% in 2022. This upward trajectory emphasises the need for transformative actions within the sector to curb its environmental footprint effectively. The figures reveal a total of 163 million tCO2e for public companies and 30 million tCO2e for

private companies, culminating in a total of 193 million tCO2e in 2022.

An additional finding from the report underscores the disproportionate impact of Scope 3 emissions, which are 4.59 times higher than the combined total of Scope 1 and 2.

Figure 2: Corporate Value Chain (Scope 3) Accounting and Reporting Standard (Credit: Greenhouse Gas Protocol)

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Figure 3: Sector Progress to Race to Zero and Breakthrough Outcome

Purchased Goods and Services emerge as the primary contributors to Scope 3 emissions. In response to this challenge, the industry has initiated a suite of collective initiatives that show promising potential to address these pressing issues. My Green Lab's ACT Ecolabel program entails third-party verification of the sustainable impacts of a lab product, its operations, and its end-of-life, facilitating sustainable procurement practices through lab product certification. It stands out as a promising solution with its potential to significantly reduce environmental impacts associated with laboratory products across their entire value chain.

Despite the challenges outlined, there is a positive trajectory observed in the commitment of major industry players to the UN-backed Race to Zero initiative. Thirty-five companies, representing a substantial 53% of the sector's revenue, have pledged their commitment to this global movement. This demonstrates a surge in determination within the industry,

indicating a collective push towards aligning with the 1.5°C threshold set by the UN's Intergovernmental Panel on Climate Change (IPCC).

Moreover, significant strides have been made towards the Breakthrough Outcome, with 63% of Pharma and Med Tech companies in the Race to Zero campaign initiating a My Green Lab Certification. Nearly half of these certifications are at a global scale, showcasing a swift integration of sustainability practices within these organisations. These developments signal both the industry's acknowledgement of the need for urgent action and its proactive engagement in initiatives that pave the way for a more sustainable future.

My Green Lab Certification: A Commitment to Sustainable Science My Green Lab Certification stands at the forefront of these transformative initiatives, serving as a catalyst for change

Figure 4: My Green Lab Certification: Reach and Growth

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Figure 5: Projection of the My Green Lab Converge Initiative

within the biotech and pharmaceutical industry toward lab sustainability. Recognised as a Race to Zero Breakthrough Outcome in 2021, this certification program spearheads efforts to reduce emissions for Scope 1 and 2, as well as the broader Scope 3 emissions.

toward a greener, more sustainable future for biotech and pharmaceutical companies.

Furthermore, My Green Lab Certification is not merely a compliance measure but a comprehensive commitment to sustainable science. Over 2,400 labs in 45 countries, comprising 26,000 scientists, have embraced this programme, realising tangible benefits in resource preservation, cost reduction, and the creation of safe and healthy laboratory environments.

and interested labs or organisations can inquire about certifying their labs. https://www.mygreenlab.org/certificationsignup.html

The certification process begins with a Baseline Assessment Survey, during which lab users self-assess their practices and achieve a baseline score. Guided by recommendations from My Green Lab's technical experts, labs proceed to implement changes. Covering 14 critical topics, including energy, water, waste, chemistry/materials, and engagement, the guidance offers a roadmap for labs to navigate the complexities of sustainability. Upon implementing the recommended changes, lab users retake the Assessment Survey, aiming for an improvement in their baseline scores. Based on the extent of improvement, labs achieve a certification level ranging from Bronze (lowest level) to Green (highest level). After achieving certification, labs continue implementing more changes, leading to re-certification every two years. The continuous improvement process ensures that sustainability best practices become ingrained in the lab's culture.

Spanning academic, biotech, clinical, government, and various other sectors, the program has become an integral part of diverse scientific communities. In essence, My Green Lab Certification is not a static achievement but a dynamic journey toward a more sustainable laboratory.

By addressing the core aspects of laboratory operations, engaging scientists in behaviour change, and promoting continuous improvement, the program contributes to building a global culture of sustainability in the scientific industry. As the industry strives to achieve net-zero carbon within the next decade, My Green Lab Certification forges the path

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More information can be obtained on our website, https://www.mygreenlab.org/green-lab-certification.html

Converge: A Collaborative Supply Chain Initiative To tackle Scope 3 emissions, the pharmaceutical industry is on a journey of change, working together on various initiatives, including My Green Lab’s recently launched Converge program. Positioned as a collaborative supply chain initiative, the Converge program uniquely draws upon the collective influence of pharmaceutical industry leaders to propel suppliers toward reducing the environmental impact of their operational labs through My Green Lab Certification.

The Converge initiative aspires to cultivate a culture of sustainability within every supplier lab. Aiming for more than just compliance, Converge envisions every scientist in the pharmaceutical supply chain actively participating in and championing lab sustainability. The broader ambition is for the pharmaceutical sector to not only lead globally in supply chain engagement but also to serve as a source of inspiration for sustainability initiatives across diverse industries.

Central to Converge's effectiveness is the My Green Lab Certification, which offers suppliers a proven process to systematically reduce the impact of their laboratories and supply chains. This tangible and measurable tool not only facilitates progress in a crucial function, but it is also low barriers to entry, which drives rapid return on investment for suppliers. Aligned with the UN Breakthrough Outcome's Campaign, the certification process becomes a powerful employee engagement tool, reinforcing a sense of purpose among participants.

For suppliers, the benefits are substantial, ranging from cost savings through reductions in energy, water, and waste

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to heightened employee engagement in sustainability, contributing to talent retention and attraction. My Green Lab is building a Supplier Dashboard to provide secure access for tracking progress, as well as releasing an Impact Estimator tool to quantify and aggregate environmental impact reductions from the program. Educational webinars and a Supplier Network Group further enhance the experience through peer-to-peer learning.

As sponsors of this program, pharmaceutical companies gain secure access to the My Green Lab Converge Dashboard, facilitating the utilisation of the Impact Estimator Tool.

Bi-annual reporting offers insights into the program's uptake and progress among Converge suppliers, leading to recognition at key industry events and through various media channels. Major pharmaceutical players, including AstraZeneca, GSK, Amgen, Merck, and Bristol Myers Squibb, are founding sponsors and are uniting in a common ask of suppliers with significant scientific operations to be 95% My Green Lab Certified by 2030.

Conclusion My Green Lab's 2023 Carbon Impact Report captures the biotech and pharmaceutical industry's progress and challenges in embracing sustainability. The report underscores the pivotal role of collective initiatives, such as the My Green Lab Certification program and Converge, in mitigating environmental footprints within laboratories and supply chains. As major industry players commit to the Race to Zero initiative, these programs emerge as drivers for change, fostering a culture of environmental

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responsibility and continuous improvement. The collaborative efforts showcased in the 2023 Carbon Impact of Biotech & Pharma report signal a positive trajectory, reinforcing the industry's commitment to the ambitious goals outlined in the UNFCCC High-Level Climate Champions' 2030 campaign and setting the stage for a resilient and sustainable global economy.

While this progress is great, the industry continues to grow, and ambitious targets back up by real action in the lab and supply chain must be accelerated for the industry to achieve the reductions necessary to achieve Paris Climate Agreement targets of 1.5°C.

Namrata Jain Namrata Jain is My Green Lab’s Marketing Consultant. Born and raised in India and living in Vancouver, Namrata is passionate about sustainability. In 2020, Namrata earned her Ph.D in Chemistry from the University of British Columbia. Namrata co-founded a sustainable science and green chemistry focused student group called GreenChem UBC and helped it grow for 4 years as a chair. I also worked as a sustainability ambassador with the UBC Sustainability Initiative. While in this role, she provided consultation to on-campus groups about running zero-waste events. Outside of her work in sustainability, she spends most of her time outdoors and is an avid traveller and photographer.

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Media and Communications

IPI

Peer Reviewed, IPI looks into the best practice in outsourcing management for the Pharmaceutical and BioPharmaceutical industry. www.international-pharma.com

JCS

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IAHJ

Peer Reviewed, IAHJ looks into the entire outsourcing management of the Veterinary Drug, Veterinary Devices & Animal Food Development Industry. www.international-animalhealth.com

IBI

Peer reviewed, IBI provides the biopharmaceutical industry with practical advice on managing bioprocessing and technology, upstream and downstream processing, manufacturing, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. www.international-biopharma.com

PNP

Pharma Nature Positive, is a platform for all stakeholders in this industry to influence decision making by regulators, governments, investors and other service providers to achieve Nature Net Positive Results. This journal will enable pharma the ability to choose the right services to attain this goal. www.pharmanaturepositive.com

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GREEN VISION Embracing Sustainable Initiatives in the Pharmaceutical Supply Chain Amidst a growing global awareness of the urgent need for sustainable practices, LogiPharma has published its first annual sustainability report, surveying 150 Heads of Supply Chain from the European life sciences sectors.

Will Robinson, LogiPharma's Conference Director, sheds light on the challenges faced in meeting sustainability targets and the innovative solutions being pursued by businesses.

With growing concerns over the climate crisis, the pharmaceutical industry finds itself at a pivotal crossroads, where stakeholders across the spectrum – from governments and health organisations to patients and the public – recognise the urgency of addressing environmental sustainability.

Consequently, the life sciences supply chain is undergoing a profound transformation, necessitating a fundamental reimagining of traditional practices.

In response to these challenges, pharmaceutical leaders are turning to the United Nations' 17 Sustainable Development Goals (UN SDGs) as a guiding framework for sustainability initiatives. These goals not only provide a roadmap for improving healthcare accessibility and quality but also emphasise the importance of reducing environmental impact by 2030. Covering a wide range of issues including poverty, inequality, climate change, and justice, the UN SDGs offer a universal blueprint for integrating environmentally responsible practices into pharmaceutical supply chains.

However, despite the industry's recognition of the importance of sustainability, LogiPharma's recent survey paints a more realistic picture. Despite progress, a huge 85% of pharmaceutical businesses consider themselves only "somewhat sustainable." Moreover, more than half of respondents admit that their sustainability goals lack concrete definition and measurable metrics. This underscores the urgent need for pharmaceutical companies to redouble their efforts towards sustainability, not only for their competitive advantage but also for their broader contribution to global environmental and social goals.

A Dose of Change With only 9% of respondents defining their sustainability goals as concrete and measurable in terms of key performance indicators (KPIs), it's evident that pharmaceutical companies must take transparent and collaborative steps forward in their sustainability efforts.

This need for action is underscored by the fact that 42% of respondents are actively cultivating a culture of sustainability throughout their organisations, while 43% are investing in circularity initiatives aimed at reducing waste and emissions.

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Interestingly, in times of uncertainty, sustainability is sometimes perceived as a source of risk rather than an opportunity. Indeed, our survey revealed that a significant 46% of respondents view a strong contradiction between supply chain resilience and sustainability.

However, the belief that these two elements are mutually exclusive overlooks the potential for symbiotic growth opportunities. By aligning sustainability practices with resilience strategies, companies can not only mitigate risks but also unlock avenues for sustainable growth and innovation.

Therefore, while the survey results may indicate areas for improvement, they also signal a significant level of maturity and development in sustainability practices within the life sciences supply chain. Moving forward, the focus should be on comprehensive mapping of supply chain sustainability credentials, including all external partners, to establish meaningful KPIs and metrics. Only through this holistic approach can companies effectively measure progress and drive meaningful change towards a more sustainable future.

Prescribing Sustainability The pharmaceutical industry holds a unique role in championing sustainability efforts through the development of life-saving medicines that enhance public health. However, stakeholders are increasingly demanding more direct interventions to ensure equity of access and affordability. One of the primary obstacles to achieving this change lies in packaging, as stringent safety standards must be met to safeguard patients.

While navigating this complex challenge, there's a notable shift towards embracing sustainability. A substantial 61% of survey respondents are actively exploring or utilising recyclable, reusable thermal packaging, indicating positive strides towards eco-friendliness.

The urgency for sustainability action is gaining prominence across pharmaceutical companies, as highlighted by our survey participants. Over half (51%) anticipate their supply chain partners to establish auditable sustainability targets, with 15% expecting Science Based Targets (SBTi). This collaborative

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approach ensures alignment across the supply chain and enhances transparency in tracking progress.

Though meaningful change requires time, there's a growing recognition of the value in transitioning towards sustainable practices. According to our findings, 33% of respondents foresee sustainability targets influencing thermal packaging decisions within 1–2 years, and 65% estimate a timeframe of 3–4 years. Despite challenges, adopting environmentally friendly packaging presents an opportunity for both greener operations and commercial growth.

Our research also sheds light on key obstacles hindering progress in sustainable temperature-controlled packaging.

A significant 65% of respondents cite understanding the CO2 impact of current packaging as a major hurdle, while 43%

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identify ‘fear of change’ as a barrier. Achieving sustainability transformation entails more than just adopting new practices – it requires a shift in mindsets and organisational culture and processes.

It is no surprise to see that for the majority of respondents there is a real tension and potential contradiction between resilience and sustainability. Resilience requires a degree of contingency, which is often at odds with efficiency. Many significant initiatives that harness digitalisation are helping to improve this picture, however. Looking into the long-term, one cannot be at the expense of another, both must be achieved, and the industry and its partners must find a way to do so.

To overcome resistance to change, supply chain leaders must engage stakeholders, address concerns empathetically, and

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GREEN VISION Recognising sustainability as a formidable challenge, the pharmaceutical industry understands that there is no one-sizefits-all solution. Top sustainability goals for 2024 among respondents include reducing air logistics in Favour of maritime logistics, enhancing emissions control, and achieving more Sustainable Development Goals (SDGs). Encouragingly, there is a notable increase in such collaboration within the industry, with numerous case studies and keynote discussions dedicated to this topic at LogiPharma 2024.

Such research highlights the industry's bold strides towards a greener and more sustainable future. As companies actively pursue their goals and commit to environmentally responsible practices, they not only contribute to a healthier planet but also foster healthier communities.

Key Takeaways Companies across the industry are facing increased scrutiny when it comes to tackling sustainability challenges. With regulations and expectations escalating, supply chain leaders are seeking effective strategies to drive sustainability forward.

While foundational transformation is inevitable, pharmaceutical companies must navigate this shift all whilst prioritising patient safety and adhering to critical safety standards.

provide clear and consistent communication about the value proposition of sustainability initiatives. This holistic approach is essential for driving meaningful and lasting change in the pharmaceutical industry's sustainability practices.

Putting a Price on Carbon Amidst the growing urgency to curb CO2 emissions, the pursuit of ambitious sustainability targets is increasingly acknowledged as essential. The CO2 impact of packaging stands out as the primary challenge for a significant portion of supply chain professionals, underscoring the imperative for enhanced collaboration between producers and packaging companies. Our survey respondents shed light on the monetary value assigned to saving 1 tonne of CO2e within their supply chains, ranging from €45 to €95.

Notably, some leaders are collaborating with their ESG teams to precisely calculate this value.

Assigning a monetary value to CO2e enables pharmaceutical organisations to pinpoint areas where emissions can be reduced and reallocate department budgets accordingly. By giving CO2 a price, players in the pharmaceutical supply chain can actively seek out products and solutions that minimise carbon emissions, driving progress towards greener practices.

Moreover, discussions are underway in many countries regarding the significant costs associated with disposing of one-way shipping solutions. The majority of respondents (81%) disclosed an anticipated average cost of EUR 250 per box for pallet shipper disposal in 2025. Opting for reusable shipping solutions presents an opportunity to mitigate cost burdens while also addressing customers' carbon footprint in drug delivery.

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The United Nations Sustainability Development Goals (UN SDGs) serve as more than just benchmarks; they represent fundamental values and a global call to action. Currently, most pharmaceutical leaders acknowledge that their supply chains are only "somewhat sustainable" in relation to the UN SDGs. However, the development of defined KPIs will facilitate a transition from ambitious aspirations to measurable actions.

Pharmaceutical packaging plays a crucial role in protecting medicines during transportation, yet many organisations are still several years away from aligning their temperaturecontrolled packaging decisions with sustainability targets. To expedite progress, the industry must understand its current CO2 impact and overcome internal resistance to change.

Elsewhere, organisations are assigning various monetary values for saving one tonne of CO2e in their supply chains, providing a strong incentive for carbon reduction efforts. Looking ahead, pharmaceutical leaders are committed to meeting more SDGs and embracing maritime logistics over air freight to advance sustainability goals.

Key Suggestions •

The UN Sustainable Development Goals (SDGs) are encouraging leaders in the pharmaceutical industry to take proactive steps and establish clear targets in advancing towards a greener future. However, achieving this goal necessitates global communication and collaboration among all stakeholders, including governments, suppliers, and individuals. Bridging this gap requires pharmaceutical companies to exhibit flexibility where possible and to continue setting practical short-term objectives.

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While organisations eager to integrate sustainability goals may encounter resistance from stakeholders and employees apprehensive about change, overcoming this hurdle is feasible. Heads of supply chain can emphasise the

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advantages of sustainability by highlighting its social and environmental benefits, listening to customer feedback, and securing support from senior management.

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Pharmaceutical leaders should prioritise initiatives with the greatest decarbonisation impact per Euro spent, ensuring a swift and financially viable transition. As the incentives for monetising carbon continue to grow, the shift towards low-carbon practices will accelerate accordingly.

To facilitate the adoption of sustainable thermal packaging, a combination of strategies aimed at reducing carbon emissions can be employed to address the inherent high-risk level. Key steps include evaluating available options, rigorous testing, and assessing organisational implications.

By taking these measures, pharmaceutical leaders stand to benefit both environmentally and economically.

Embracing Sustainable Initiatives Embracing sustainability within the pharmaceutical industry transcends being merely a necessity; it represents an opportunity to forge a healthier and more resilient future for all stakeholders.

From patients dependent on life-saving medications to communities grappling with the repercussions of environmental degradation, the significance of sustainable initiatives cannot be overstated.

It’s crucial for pharmaceutical companies to recognise that sustainability is not just a responsibility but also a strategic imperative in today's rapidly evolving landscape. Embracing sustainability not only enhances brand reputation and stakeholder trust, but also drives innovation and drives long-term profitability.

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By prioritising sustainable practices, pharmaceutical companies are able to mitigate risks associated with environmental and social concerns but also pave the way for their long-term viability and success. Moreover, they play a pivotal role in advancing broader global endeavours toward fostering a more equitable and environmentally conscious society.

Through proactive engagement with sustainability, pharmaceutical enterprises can enhance innovation, drive positive societal change, and contribute meaningfully to the collective industry goal of building a more sustainable world. In doing so, they not only fulfil their ethical obligations but also embrace the opportunities inherent in shaping a brighter future for generations to come.

Will Robinson Will Robinson, Conference Director, LogiPharma, with over a decade of industry experience, Will Robinson is responsible for the strategic direction, editorial content, and commercial growth of a £7m+ portfolio of events as part of the Worldwide Business Research (WBR). With its flagship event, LogiPharma Europe, taking place in April 2024, as Conference Director, Will works with various leading pharma companies and supply chain heads to decipher industry trends, devise effective approaches, and curate top-notch content. With an attendance of around 200 speakers and 2000 participants, LogiPharma strives to create a platform that facilitates insightful discussions and fosters industry connections.

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GREEN VISION Insights from Owen Mumford: Life Cycle Assessment for Drug Delivery Devices Scope 3: A Stone Left Unturned The burden of carbon emissions from the healthcare sector is well documented, with the industry responsible for around 5% of global emissions.1 Half of these emissions can be attributed to the US, EU, China and the UK. However, the sector has laid out ambitions to move towards a greener future, with healthcare services around the world following the lead of the UK’s National Health Service (NHS), the first organisation to formally set targets for net zero by 2045.2 For the pharmaceutical sector, this was also a call to action, since the NHS’ 80,000 suppliers must also be able to demonstrate they are on track to achieving net zero by 2045, or risk losing NHS business.3 The pharmaceutical industry is already making good progress in tackling scope 1 and scope 2 emissions.4 However, scope 3 emissions – caused by assets not directly owned or controlled by the reporting company – are proving trickier to tackle. With these emissions often comprising as much as 70% of a company’s total carbon footprint,5 future targets are likely to see greater attention on scope 3 as companies seek to strengthen sustainability across all aspects of their businesses.

Owen Mumford’s Holistic Approach As a drug delivery device manufacturer working in partnership with pharmaceutical companies, Owen Mumford Pharmaceutical Services (OMPS) is part of a complex network of suppliers that must be able to demonstrate how they are strengthening their sustainability credentials. Of course, reducing overall emissions entails a multifaceted approach, looking at facilities management and manufacturing processes as well as product composition and transport.

There is no escaping that Owen Mumford Pharmaceutical Services manufactures single-use medical devices (though there is a renewable auto-injector on the way), but this is why it is critical to take a holistic approach that assesses every area where there is potential to reduce impact. There are various initiatives in place at Owen Mumford to help the business maintain momentum and achieve its environmental, social and governance (ESG) objectives, including B Corp certification, emissions targets approved by the Science Based Targets initiative (SBTi), and a focus on selected Sustainable Development Goals. These initiatives are all discussed in more detail in the inaugural issue of Pharma Nature Positive.

This article focuses on the challenge of building a life cycle assessment tool, for understanding the environmental impact of existing products and bringing sustainable decision making to the forefront for new designs. Conducting a life cycle assessment reveals critical information to shape the design of a device and

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improve sustainability without compromising usability or safety.

A tool or process for life cycle assessment is not a nice-to-have; it is now a must to be able to demonstrate to all stakeholders that a thorough analysis has taken place. However, creating such a tool is a complex process that all device manufacturers grapple with. One solution is greater knowledge sharing on this topic, to help companies resolve issues faster, with the added benefit of helping to create similar standards of assessment across the industry.

Creating a Sustainability Decision-making Tool The ISO 140406 standard provides the principles and framework for a Life Cycle Assessment (LCA), addressing the environmental impact of a product at each development stage, from raw material acquisition to production, end-of-life treatment, recycling and final disposal. The resulting deeper understanding of product impact helps identify areas for improvement and informs design decisions that can minimise environmental footprint.

Owen Mumford Pharmaceutical Services developed its own bespoke life-cycle-based eco-design tool in collaboration with a world-leading LCA consultancy, PRé Sustainability. The tool allows us to create a projection of the environmental impact of new product concepts, from raw material extraction to disposal. The platform used was a completely new iteration of PRé’s existing software, built and beta tested as the project developed.

An important point to note is that the tool is not designed for formal reporting of product impact; its use is purely internal. We prioritised simplicity in the design, ensuring the tool can easily be used by those who are not experts, without compromising on the accuracy of its output.

The tool has two core uses that can improve the sustainability performance of OMPS’ devices. Whilst we are working on delivering full ISO 14040-compliant LCAs for our existing products, it allows us to quickly estimate the baseline impact for each existing product, allowing for greater understanding of the overall impact of entire product lines. By building scenarios that also take into the account the market for existing products, their

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GREEN VISION distribution route and supply chains, we can create a detailed overview of current product footprint.

A second use is when creating entirely new products. The tool allows us to build scenarios to examine different product concepts and configurations. We can assess multiple device characteristics including component weights, packaging and efficiency, transportation, material choice and supply, manufacturing location, and various end-of-life scenarios.

We can then review whether modifications in these categories would improve the overall sustainability ‘score’. The scenariobased model is crucial because simple, and big, decisions can be quickly assessed for likely scale of sustainability improvement and for potential unintended consequences, also known as ‘burden-shifting’.

Tool Methodology and Parameters Owen Mumford’s LCA tool uses data from Ecoinvent – a world leading database for LCA, comprising datasets modelling human activities and processes, and the resulting impact.

Our methodology accounts for 17 potential impact categories of devices including, for instance, climate change, water use, land use, human toxicity, mineral resource and fossil resources.

These categories are associated with three potential negative outcomes: damage to human health, damage to ecosystems or damage to resource availability. Evaluating the impact across this broad range of categories helps to capture a variety of sources of environmental damage and identify where in the product life cycle they occur.

Simply inputting distinct parameters of a device, its supply and distribution into the tool delivers an estimated impact for each category. The results can then be compared to different iterations of the same product or others in our portfolio. To test the tool’s accuracy, we carried out a comparison with a fully peer reviewed LCA which included real-world data; our tool’s projections were within 1% of the full LCA. In this way, the tool is exceptionally useful for our understanding of why certain designs do or do not work from an environmental perspective. When working with so many competing factors during the design process, a clear illustration of benefits and drawbacks is immeasurably useful. Projections from the tool feed into Research & Development, ensuring product designs prioritise sustainability from the outset and that their unintended impacts are limited as far as possible.

Focus: Material Use To reduce environmental footprint, manufacturers will increasingly be looking to use recycled materials when creating new designs, and reducing the prevalence of petroleum based plastics. Presently, bioplastics represent just 3% of all medical polymers in medical devices but evolutions in 3D printing should allow increased customisation with speed, accuracy, and quality.7 Of course, there are issues around bioplastics that must be acknowledged – and will be by LCA tools – to ensure they are the most suitable choice for improving sustainability.

For instance, producing bioplastics is land intensive and can take away from crucial agricultural space needed to feed a growing population. Some data suggests that when all factors are taken into account, renewable feedstock may offer little or no benefit to key measures such as Global Warming Potential when

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Sustainability at Owen Mumford Pharmaceutical Services As a supplier to pharmaceutical companies – and therefore a contributor to scope 3 emissions – Owen Mumford Pharmaceutical Services is conscious of its role in helping to create a more sustainable healthcare sector. We have therefore committed to a number of sustainability goals and have already begun to make significant progress in tackling our emissions.

We became one of the first medical device companies to achieve B Corp certification – a rigorous sustainability assessment covering company practise and outputs across five categories: governance, workers, community, the environment and customers. We have also signed up to the Science Based Targets initiative (SBTi), which independently assesses sustainability targets in line with strict criteria to gauge their viability. The SBTi has validated our near-term targets to reduce absolute scope 1, 2 and 3 greenhouse gas emissions by 42% by 2030. Our long-term aim to reach net-zero across our supply chain by 2045 was also approved.

To help us stay on track, we share a Responsible Action Report each year, charting our progress against various sustainability goals. This year for example, we have made significant strides in our logistics departments, optimising our UK offsite storage network and our factory-to-factory movements. Together, these measures are predicted to make savings of 49,500 kg of CO2e per annum. One of our next focus areas is scrap reduction initiatives in both the moulding and assembly stages of production. compared to fossil-based feedstocks. As we review biomaterial footprint, we must ensure methodologies and system boundaries are sound, including the allocation of sequestered carbon (CO2 absorbed by the feedstock material), to create a true picture of the environmental impact of materials.

Creating efficient device designs relies on selecting materials and geometry which achieve an optimal combination of: emission factor per unit mass, strength and stiffness per unit mass, manufacturing-related mass constraints, mass-andprocess-related manufacturing emissions, downstream size and mass-related impacts such as packaging, distribution and end of life. Device designs and packaging are then likely to be streamlined, reducing the use of plastics and metal components where possible without impacting the safety or usability of products.

Focus: Resource Use Apart from substituting raw materials, suppliers can also reduce their use of finite resources. This involves decreasing the amount of abiotic resources, such as light, fuel, water and chemicals used to manufacture, transport, deploy and employ, recover and recycle/dispose of the product throughout the supply chain.

When assessing opportunities to reduce energy use, it is important to carefully consider energy suppliers. Not only should companies consider whether suppliers are using renewable energy, they should also check the financial mechanism through

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GREEN VISION which that renewable energy is obtained. Working with suppliers who put investment back into renewable energy generation is a bonus for sustainability goals. Direct Power Purchase Agreements (PPAs) may be more robust in terms of ‘100 % renewable’ energy generation than sleeved or virtual PPAs, supported by renewable energy certificates.

Focus: Recycling and Disposal From inception, companies must think about designing for circularity, addressing questions about product end of life. Device designers should prioritise materials that can be recycled at their highest value – meaning they will be reused in the same or similar applications. Suppliers must strike a balance between ensuring the longevity of a product and reducing its manufacturing footprint. Deciding on the best method for recycling products is by no means easy either. Although highest value recycling is often the goal, the reality in terms of processing materials may mean it is not the most sustainable solution. In such cases, manufacturers must decide how products can be recycled at their ‘next best’ point of value – as components or assemblies – or at the ‘least best’ point of value, as raw materials.

Focus: Innovative Approaches With our Aidaptus® autoinjector, we prioritised flexibility in our approach, creating a device with a wide design envelope to allow compatibility with different formulations, fill volumes, needle sizes and primary containers. Not only does this flexibility reduce risk for pharma partners, since any change in formulation during development does not necessitate a change in device, but it can also support sustainability goals. Pharma companies can use Aidaptus as a single platform for multiple applications, reducing environmental impact of combination products at the manufacturing stage.

Alternatively, companies may look to flex the delivery device brief around the state of the drug. Lyophilised (freeze dried) drugs that are then recombined through the device at point of administration can create various benefits. Waste is reduced thanks to a longer shelf life and increased stability, while the ability to transport and store at room temperature also significantly reduces the environmental impact.8 The Road to Greater Sustainability We know that stakeholders across the medical device industry are working tirelessly to create greener products by reducing the use of harmful materials and improving the ease of recycling and disposal. This is essential to improve scope 1, 2 and 3 emissions across all stakeholder organisations involved in providing healthcare products.

However, the complexities of a product’s lifecycle mean actions that appear to make a product more environmentally friendly on the surface can do more harm than good. Using a sophisticated life cycle analysis tool will help manufacturers understand the true impact of products and ensure new designs are developed according to solid environmentally friendly concepts. In turn, this should lead to the achievement of ambitious sustainability goals in the near and long-term.

REFERENCES 1.

Reuters. (2024). Big pharma pulls together to shrink healthcare’s outsized carbon footprint. https://www.reuters.com/sustainability/

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2.

3.

4.

5.

6.

7.

8.

climate-energy/big-pharma-pulls-together-shrink-healthcaresoutsized-carbon-footprint-2024-02-14/ NHS England. (2020). NHS becomes the world’s first national health system to commit to become ‘carbon net zero’, backed by clear deliverables and milestones. https://www.england.nhs.uk/2020/10/ nhs-becomes-the-worlds-national-health-system-to-commit-tobecome-carbon-net-zero-backed-by-clear-deliverables-andmilestones/

Reuters. (2024). Big pharma pulls together to shrink healthcare’s outsized carbon footprint. https://www.reuters.com/ sustainability/climate-energy/big-pharma-pulls-togethershrink-healthcares-outsized-carbon-footprint-2024-02-14/ National Library of Medicine (2023). Pharmaceutical Company Targets and Strategies to Address Climate Change: Content Analysis of Public Reports from 20 Pharmaceutical Companies. https://www.ncbi.nlm.nih. gov/pmc/articles/PMC9967855/#:~:text=Companies%20 showed%20largely%20favorable%20reductions,%2C%20 water%2C%20and%20raw%20materials.

World Economic Forum (2022). What is the difference between Scope 1, 2 and 3 emissions, and what are companies doing to cut all three? https://www.weforum.org/agenda/2022/09/ scope-emissions-climate-greenhouse-business/ ISO. ISO 14040:2006. https://www.iso.org/standard/37456. html Medical Plastics News. (2023). An introduction to bioplastics in medical applications. https://www.medicalplasticsnews. com/medical-plastics-industry-insights/ medical-plastics-materials-insights/an-introduction-tobioplastics-in-medical-applications/ Broughton. (2023). Lyophilized products: The benefits of freeze drying to increase product shelf-life and stability. https://www.broughton-group.com/blog/lyophilizedproducts-the-benefits-of-freeze-drying-to-increaseproduct-shelf-life-and-stability#:~:text=It%20involves%20 freezing%20a%20product,primary%20drying%2C%20and%20 secondary%20drying.

Oli Gould Oli Gould is an experienced Design Manager with a background in engineering and 10 years working in medical device development, preceded by several years working with household consumer technology brands.

As R&D Sustainable Solutions Lead at Owen Mumford, Oli supports the development of innovative new medical devices. Alongside a range of competences, Oli specialises in engineering analysis and environmental sustainability in product development.

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GREEN VISION Driving Sustainable Manufacturing Forward

In today’s world, where the threat of climate change looms large, the pursuit of sustainable practices in the pharmaceutical industry isn’t just a trend – it’s a necessity.

Here at WuXi STA, we’re more than just participants; we’re pioneers. As a global leader in Contract Research, Development, and Manufacturing (CRDMO), we produce thousands of investigational and marketed innovative drugs for all synthetic modalities at all scales every year. We’re passionately investing in carbon footprint reduction, driving innovative breakthroughs, and leading the change toward a sustainable future in our industry.

Our mission embodies more than business goals; it’s about contributing positively to the world, aligning our scientific advancements with a vision of health and sustainability for everyone.

Our Target by 2030 Compared to the 2020 Baseline We concentrate our sustainability efforts in four key operational areas where we make a significant difference:

Water Resource Management Through innovative technologies and responsible practices, we achieved a 41% reduction in water consumption in 2022 vs. 2021.

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In 2018, our Wuxi City site initiated a new water reclamation and reuse project. By employing an innovative treatment process, we successfully repurposed production wastewater for non-production purposes. This initiative not only achieved zero discharge of production wastewater but also significantly contributed to the overall reduction of water consumption, lessening the environmental impact of the site. In 2022, the total amount of reclaimed water reached 51,861 tons.

Carbon Emissions: 25% intensity reduction Energy Consumption: 25% intensity reduction Water Resource Management: 30% intensity reduction Waste Management: Be landfill-free for all productive hazardous waste by 2030.

Carbon Emissions and Energy Efficiency In 2022, we achieved a remarkable 36% reduction in carbon emissions year-on-year and reduced our overall energy consumption by 37% through strategic initiatives and sustainable practices across all sites globally.

Showcase of WuXi AppTec’s ESG Award Achievements Our Couvet site in Switzerland operates entirely on renewable energy that leverages local weather conditions with solar panels and LED lights to enhance energy efficiency. Geothermal energy is harvested from the earth’s subsurface using a system of 266 heat exchange piles drilled deep underground. This innovation results in an impressive 70% lower CO2 emissions compared to similar-sized facilities in the pharmaceutical industry.

At our Wuxi City drug-product site in China, we have installed energy-saving heat pipes in the Heating Ventilation and Air Conditioning (HVAC) fresh air treatment section. This ensures waste heat recycling, saving an estimated 42,000 kWh of electric energy annually. Similarly, our Changzhou API site utilises heat recycling devices for air compressors, saving an estimated 2,600 tons of steam annually. This is coupled with our VAR38 incinerator’s flue gas heat-exchange system, which reduces 98,000 tons of purchased steam.

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These measures, including our investment in water recycling technologies and continuous monitoring of water usage, enable us to maintain efficiency while ensuring that our operations align with the highest standards of environmental stewardship. Our commitment to sustainable water management was recognised globally, reflecting our mission to contribute positively to a world where water resources are conserved and used responsibly.

Solid Waste Management In July 2020, our parent company, WuXi AppTec, launched precious metal recovery, and we have significantly improved the recovery process in recent years. We have engaged all suppliers for heterogeneous catalyst recovery, tracking the process of catalyst collection and use, ensuring that precious metals can be recovered to the maximum level.

In 2022, we successfully recovered approximately 385.5 kg of precious metals, contributing to our overall waste reduction efforts.

Process Mass Intensity (PMI) Management As a recognised leader in synthetic chemistry, we have

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GREEN VISION embedded process mass intensity management into every stage of our research, development, and manufacturing processes. PMI is a metric that measures the ratio of kilograms of raw materials used per kilograms of product manufactured.

In 2022, we achieved an impressively low combined PMI of 41 across our API manufacturing sites, reflecting our commitment to eco-friendly practices.

Workflow of API Process Development and Manufacturing for Greener Processes Our approach to API process development and manufacturing incorporates advanced and environmental-friendly technologies, such as biocatalysis and flow chemistry. From the design of new synthetic routes to work-up development and process transfer, we prioritise green process technologies and waste control. By adhering to the 12 Principles of Green Chemistry and focusing on continuous improvement through a PMI scorecard, we transcend regulatory compliance and exemplify our unwavering commitment to sustainable manufacturing.

As a pioneering leader in the healthcare industry, we recognise the profound connection between climate change,

public health, and sustainable manufacturing. Faced with these global challenges, we are committed to the best sustainable practices, creating a path toward a healthy future for our planet.

WuXi STA WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organisation (CRDMO), WuXi STA offers its world-wide partners efficient, flexible, and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecules, oligonucleotides, peptides and various complex chemical conjugates. For more information, please visit our website.

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GREEN VISION SÜDPACK MEDICA Offers Innovative Solutions for the Pharmaceutical Industry In many industries, responsible, sustainable business activity is already an integral part of corporate strategies.

There is increasing pressure also on the pharmaceutical industry because suppliers and stakeholders alike face new requirements and legal regulations in the near future. Just some examples are the Corporate Sustainability Reporting Directive, the EU’s Green Deal and the Supply Chain Duty of Care Act. One area that offers real potential for companies to improve their environmental impact today is product packaging.

Most global players on the market have already pledged to reduce their resource consumption, implement greener production technologies and cut packaging waste. Often, their declared goal is climate neutrality.

Both Challenge and Opportunity Companies can take the first steps by implementing measures such as switching to renewable energies, embracing e-mobility and using smaller secondary packaging tailored to their products. However, the pharmaceutical and life science industry is hampered by strict regulations and complicated approval and qualification procedures for their products. This also applies to product packaging, which makes changing to greener packaging concepts very costly and time consuming. However, with new approval procedures, companies have the opportunity to improve sustainability today without additional expenses. They can choose a recyclable alternative for their primary packaging.

As a proven partner to the healthcare industry for many years, SÜDPACK MEDICA has a profound understanding of these requirements. The company is one of the most innovative suppliers of high-performance films.

At an early stage, its management recognised the complex challenge of combining product protection and sustainability in a single solution. Ever since, the company has been working intensively on developing more material-efficient, recyclable solutions for the pharmaceutical and medical goods industry that meet stakeholder requirements and also its own sustainability goals.

First Concepts Available on the Market PharmaGuard is one of these innovative concepts. The new blister solution from SÜDPACK MEDICA for both solid and liquid applications has been available since 2023. It is a recyclable alternative to conventional, non-recyclable packaging concepts. The polypropylenebased top and bottom webs are manufactured in a specially designed coextrusion process and, as a mono-material solution, they can be allocated to existing material streams after use. Thanks to the low PP density, the packaging system also achieves an excellent material efficiency. According to a life cycle assessment conducted by Sphera, PharmaGuard is

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associated with a greatly reduced climate impact (in CO2-eq) as well as lower energy and water consumption compared to other popular blister solutions composed of PVC/PVdC and aluminum. Nevertheless, PharmaGuard is equally effective in terms of barrier functions and mechanical properties. For example, the concept provides an excellent water-vapour barrier in compliance with pharmacopoeia requirements and also features high transparency.

Furthermore, the films can be efficiently processed on existing packaging lines with only minor modifications. The strong sealing performance and excellent thermoforming properties of the material as well as the uniform molding characteristics of the base film guarantee maximum packaging quality and process reliability.

Continued Development With this groundbreaking solution, SÜDPACK MEDICA is sending a strong signal to the industry. Managing Director Thomas Freis considers the development of sustainable packaging concepts to be still in its infancy. However, at trade shows such as the CPHI in Barcelona and the Pharmapack in Paris, PharmaGuard attracted exclusively positive interest. Furthermore, in fall 2023 the blister concept received the renowned German Packaging Award, followed in early 2024 by the World Star Packaging Award in the category “Sustainability / Recyclability”.

“The upcoming PPWR (Packaging & Packaging Waste Regulation) will massively tighten the requirements for aspects such as packaging design, recyclability and proportion of recycled materials in the manufacture of packagings based on synthetic materials. The regulation, which will be mandatory throughout the EU, initially does not apply to the packaging of medical and pharmaceutical goods, but at some time in the future it will be expanded to include this market. That’s why, as a key supplier, we are already moving in this direction.”

With PharmaGuard, SÜDPACK MEDICA has impressively demonstrated that a conventional blister packaging based

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GREEN VISION on PVC/PVdC and aluminum can already be replaced by a resource-saving, recyclable alternative without compromising on packaging quality or product safety and process reliability.

“We Need a Holistic Approach to Sustainability!”

SÜDPACK MEDICA is going even further. The company is thinking bigger – and in greater dimensions. It recently implemented an LCA tool in the entire company group in order to holistically evaluate and optimise the environmental impact of packaging solutions. PharmaGuard was one of the first products to be analysed by the LCA tool.

“We believe you can only achieve a robust analysis by looking at the real environmental impacts of a packaging, including its recyclability. Only then is it possible, based on the facts, to reach an intelligent decision on an optimal, sustainable packaging concept,” says Jürgen Bodenmüller, Head of the Development and Business Development division.

However, the tool is not only be used in the product development process, as it was for PharmaGuard. As from the end of 2023, it is also available to all SÜDPACK customers who want to check out their existing packaging solutions as well as examine more sustainable alternatives.

When Designing the LCA Tool…

SÜDPACK deliberately modeled various end-of-life scenarios in order to underpin customer consulting and product decisionmaking with hard facts. For example in the case of flexible films, roughly 15% of the carbon footprint (with an average re-cycling rate of 46% so far in Germany and a thermal recycling rate of 54%) is generated in the phase after use, otherwise known as end-of-life. Using mechanical recycling as an alternative to thermal utilisation, the carbon footprint can be reduced by up to 80%. In the case of chemical recycling, the difference compared to thermal utilisation is around 50%.

According to Jürgen Bodenmüller, chemical recycling is “an exciting option especially for packaging waste involving various material structures, or for contaminated plastics which at present can’t be recycled. That’s because chemical recycling recovers hydrocarbons in virgin-grade quality, and we can reintroduce this valuable resource into the loop.”

Progress Based on Facts A paradigm shift in industries, companies, and hearts and minds can only happen if fundamental questions are answered first: What is sustainable packaging? What sustainable alternatives are suitable for pharmaceutical and medical goods packagings?

What technologies and infrastructures are necessary to enable a cost-effective circular economy for currently non-recyclable composite structures?

With its own material management system, comprehensive realignment of the portfolio towards resource-saving, recyclable packaging alternatives, and investment in mechanical and chemical recycling technologies, the SÜDPACK Group has in recent years already created facts on the ground. It has not only developed an effective circular economy for its products in its field, but can also support customers in diverse industries with solid expertise, groundbreaking product developments and well-founded sustainability analyses.

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Visit us at CPHI, booth 20F58 08–10 October, 2024 in Milano Following Link to Video which can be implemented: https://youtu.be/TsChN0hqF3s

SÜDPACK MEDICA AG SÜDPACK MEDICA is headquartered in Baar (CH) and is one of the leading suppliers of sterile packaging solutions in Europe as well as a pioneering partner for the global medical, pharmaceutical and diagnostics industries. The company is part of the SÜDPACK company group and was founded in 1989. The core competency of SÜDPACK MEDICA is the development of plastic-based packaging solutions for sterile goods. The product and performance range of SÜDPACK MEDICA extends from standard solutions to tailor-made, customer-specific packaging concepts. It includes the production of coextruded flexible and rigid films, which are used as base and lidding films, and of pre-made pouch solutions for a wide variety of products. SÜDPACK MEDICA also benefits from the SÜDPACK Group’s long-standing leadership in technology and innovation in the coextrusion of polymer-based film solutions. The production of SÜDPACK MEDICA products is performed at four sites in France, Germany, Switzerland and the Netherlands. These sites are equipped with the latest plant technology and manufacture to the highest standards of quality and hygiene, including the capacity to operate under clean room conditions. For optimal support and collaboration with their customers around the world, SÜDPACK MEDICA relies on a specialist team working in quality, sales, development and application technology, one that has long-standing expertise in polymers and process engineering and in the market for sterile packaging. This makes SÜDPACK MEDICA a competent solutions partner for their customers when it comes to the implementation of packaging solutions, including those with the most demanding requirements. SÜDPACK is committed to sustainable development and fulfills its responsibility as an employer and towards society, the environment and its customers. With its own site for processing biopolymers and its own compounding facilities, the SÜDPACK Group is also among the trailblazers in the production of forwardlooking, sustainable and recyclable packaging concepts.

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GREEN VISION Understanding the Corporate Sustainability Reporting Directive in Europe and Its Implications for Medium-Sized Companies The issue of sustainability has garnered increasing attention across the globe, with particular emphasis on small and medium-sized enterprises (SME). These companies, typically characterised by employee counts ranging from 250 to 1,000, are integral to the economic fabric and play a crucial role in environmental stewardship. According to the Environmental Social Governance (ESG) study by the Smarter Service Institute, in 2022, sustainability responsibilities were primarily shouldered by the management or CEO in 64 percent of surveyed companies. This indicates a top-down approach, emphasising the critical importance of sustainability at the highest levels of corporate governance.

In this evolving landscape, the European Union's introduction of the Corporate Sustainability Reporting Directive (CSRD) represents a significant milestone. The CSRD mandates enhanced and standardised sustainability reporting for companies within the EU, aiming to rectify deficiencies in the existing Non-Financial Reporting Directive (NFRD). It is set to impact an estimated 50,000 companies, a substantial increase from the 11,000 previously covered under the NFRD. The directive is a comprehensive framework designed to enhance transparency and accountability in corporate sustainability practices, ensuring that companies provide consistent, comparable, and reliable sustainability information.

For SMEs in Europe, the CSRD presents both a challenge and an opportunity: The directive necessitates a comprehensive reporting framework with detailed information on environmental, social, and governance factors.

This enhanced reporting requirement means that SMEs will need to dedicate significant resources to gather, verify, and present sustainability data. As pharma companies are working with strict routines and precise documentation, a reliable reporting can be expected in this sector.

The implementation of the CSRD will undoubtedly increase the workload for any enterprise. These companies will need to invest in new systems and processes to capture relevant data accurately. Furthermore, they must ensure their sustainability reports comply with the European Sustainability Reporting Standards, which are being developed to provide clear guidelines on what needs to be reported.

Workload and Compliance Challenges One of the primary challenges will be the collection and management of extensive ESG data. SMEs will need to establish robust mechanisms to track their environmental impact, social contributions, and governance practices. A field which is well

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known in the pharma branch. This might involve upgrading IT infrastructure, training staff, and possibly hiring new personnel with expertise in sustainability reporting. The data collection process will require meticulous attention to detail to ensure that all relevant information is captured accurately and comprehensively. To ensure the credibility of the reported data, companies will need to undergo external verification.

This step, while crucial for maintaining transparency and accountability, adds another layer of complexity and cost.

Engaging with third-party auditors or certifying bodies will become a necessary part of the reporting process. Verification provides an additional layer of scrutiny, ensuring that the data presented is accurate and reliable. This process may involve regular audits and assessments to maintain the integrity of the sustainability reports. Adhering to the ESRS will require companies to stay abreast of evolving regulations and best practices in sustainability reporting. This ongoing need for compliance will demand continuous education and adaptation, ensuring that reports not only meet regulatory requirements but also reflect the company's genuine sustainability efforts.

Staying updated with the latest regulatory changes and industry standards is crucial to maintaining compliance and avoiding potential penalties or reputational damage.

Opportunities for Enhanced Sustainability and Market Positioning While the increased workload is significant, the CSRD also offers numerous opportunities. Standardised reporting can enhance a company’s sustainability profile, providing a competitive edge in an increasingly eco-conscious market. By adhering to the CSRD, SME can significantly enhance their transparency. Comprehensive and standardised reporting allows stakeholders, including investors, customers, and employees, to gain a clear understanding of the company’s sustainability efforts. This transparency can build trust and strengthen the company’s reputation. Clear and transparent

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GREEN VISION reporting helps to establish the company's commitment to sustainability and responsible business practices, fostering greater trust and loyalty among stakeholders.

The rigorous data collection and analysis required by the CSRD can lead to improved operational efficiency. By closely monitoring resource use, waste management, and other sustainability metrics, companies can identify areas for improvement and implement more efficient practices. This not only reduces environmental impact but can also result in cost savings. Efficient resource management can lead to significant cost reductions, enhancing the overall profitability and sustainability of the company. Furthermore, the effort to focus on sustainable usage of resources will be triggered. Regrettably, most of the packaging in the pharma industry is made of plastics.

With good reason, as a sterile solution is needed. But the CSRD can pioneer the path to new solutions fresh thinking.

In an era where consumers and investors are increasingly prioritising sustainability, companies that can demonstrate robust ESG practices will likely enjoy a competitive advantage. The standardised reporting mandated by the CSRD ensures that all companies can effectively communicate their sustainability credentials, potentially attracting more business and investment.

A strong sustainability profile can differentiate a company from its competitors, making it more attractive to eco-conscious consumers and investors who prioritise ethical and sustainable business practices.

Investors are increasingly incorporating ESG criteria into their decision-making processes. By providing clear and reliable sustainability reports, smaller companies can appeal to a broader range of investors. This can enhance their access to capital and facilitate growth and expansion. Companies with strong ESG performance are often seen as lower-risk investments, making them more attractive to investors seeking long-term value and stability.

Navigating the Transition: A Strategic Approach The transition to CSRD compliance requires a strategic approach, focusing on integrating sustainability into the core business operations of SME. Effective implementation begins with strong leadership commitment. As highlighted in the ESG study, 64 percent of medium-sized companies place sustainability responsibility on the management or CEO. This top-level involvement is crucial for driving the necessary changes and ensuring that sustainability is embedded into the corporate culture. Leadership commitment signals the importance of sustainability to the entire organisation and ensures that it remains a priority across all levels of the company.

Building internal capacity is essential. Companies should invest in training programs to equip their employees with the knowledge and skills required for sustainability reporting.

Additionally, creating dedicated roles such as environmental or sustainability managers can help streamline efforts and ensure accountability. Investing in employee training and development is critical for building the necessary skills and expertise to manage and report on sustainability initiatives effectively.

Collaboration with external stakeholders, including industry associations, regulatory bodies, and other companies, can provide valuable insights and resources. Engaging with these

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stakeholders can help SME stay informed about best practices and emerging trends in sustainability reporting. Partnerships and collaborations can also provide access to additional resources and expertise, enhancing the company's ability to meet its sustainability goals.

Leveraging technology can significantly ease the reporting burden. Implementing advanced data management systems and sustainability software can streamline data collection, analysis, and reporting processes. These technologies can also facilitate real-time monitoring, enabling companies to make informed decisions and respond swiftly to sustainability challenges.

Advanced technology solutions can enhance data accuracy, efficiency, and transparency, making it easier for companies to comply with reporting requirements.

Overcoming Challenges: A Roadmap to Success SMEs must adopt a proactive approach to address the challenges associated with the CSRD. Developing a clear roadmap and action plan is essential for successful implementation and compliance. This involves setting clear objectives, identifying key milestones, and allocating the necessary resources to achieve sustainability goals. Establishing clear and measurable objectives is crucial for guiding sustainability efforts. They should define specific targets and key performance indicators that align with the CSRD requirements.

Clear objectives provide a roadmap for achieving sustainability goals and enable companies to track progress and measure success. Breaking down the implementation process into manageable milestones helps companies stay on track and monitor progress. Identifying key milestones ensures that the company remains focused on achieving its sustainability objectives and can make necessary adjustments along the way. Regularly reviewing and assessing progress against these milestones helps to maintain momentum and drive continuous improvement. Allocating the necessary resources, including budget, personnel, and technology, is critical for successful implementation.

Medium-sized companies must ensure that they have the required resources to meet the demands of the CSRD and achieve their sustainability goals. Adequate resource allocation enables companies to effectively manage the increased workload and ensure compliance with reporting requirements.

Sustainability is an ongoing journey, and continuous improvement is essential for long-term success.

All companies should regularly review and assess their sustainability practices, identify areas for improvement, and implement necessary changes. Continuous improvement helps companies stay ahead of regulatory requirements and maintain a strong sustainability profile.

The CSRD represents a pivotal shift towards enhanced sustainability practices and transparency in Europe. For SMEs, while the increased workload poses a challenge, it is a challenge that can be met with strategic planning and commitment.

The directive offers an opportunity to not only comply with regulatory requirements but also to lead in sustainability. By embracing the CSRD, SMEs can enhance their operational

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efficiency, build trust with stakeholders, and gain a competitive edge in the market. As companies navigate this transition, strong leadership, capacity building, collaboration, and technology integration will be key to success.

In conclusion, the CSRD is a call to action for medium-sized companies to elevate their sustainability efforts. It is a challenge, but one that offers significant rewards. Richter-BioLogics as a GMP-compliant contract development and manufacturing organisation (CDMO) for biologics production for the global pharma industries follows heavily regulated processes day by day. This ensures highest product quality for the health of people for more than 35 years. Richter-BioLogics took a step forward and addressed these challenges to contribute to a more sustainable future while securing it´s long-term success. The path ahead requires dedication and innovation, but with the right approach, the benefits will far outweigh the efforts. By

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integrating sustainability into their core operations and adhering to the CSRD requirements, SME can position themselves as leaders in sustainability, driving positive change and making a meaningful impact on the environment and society.

Michael Gorek Michael Gorek is a seasoned financial professional with extensive experience in various roles. Currently, he serves as the Head of Controlling at RichterBioLogics GmbH & Co. KG. His previous roles include Senior Manager Asset Processes and various Business Analyst roles. He holds a Business Administration degree from Wirtschaftsakademie Hamburg.

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GREEN VISION Pharmaceutical Packaging and the Plastic Dilemma: Can PCR Materials Make a Difference?

Modern pharmaceutical packaging relies heavily on plastic, owing to its wide variety of uses and benefits, including sterility and durability, whilst also being chemically inactive or inert.

However, considering the growing fight against plastic waste, tightening environmental regulation and changing public opinion, it is vital pharma finds new and more responsible ways to use plastic within its primary and secondary packaging.

Using either post-consumer or pre-consumer regrind (PCR) materials is one approach that can potentially make a positive difference. This involves using recycled plastic from end users and/or waste from the production process to create new packaging systems.

In this article, we explore the growing use of PCR in pharmaceutical packaging, its benefits and challenges, as well as discussing the reasons why a demand-led, responsible and pragmatic approach is necessary.

PCR: A Win-Win for Pharma and the Planet?

Pre-consumer regrind or Post-industrial recycled (PIR) material is manufacturer waste (such as off-cuts, trimmings and rejects), which is repurposed to create recycled packaging or products.

Post-consumer regrind is consumer waste diverted from landfills and used in the production of plastic packaging or products.

The PCR market is being driven by growing consumer awareness about environmental issues and the increasing rise in petroleum prices.

This is driving a surge in demand for PCR globally, with many businesses eager to embrace this innovation.

The benefit of PCR makes it even more attractive, despite its sustainability benefits like reducing waste, lowering the carbon footprint of manufacturing, and promoting a circular economy. For example, PCR reduces manufacturer costs as fewer, more expensive, virgin materials are needed in production.

costs of expensive new drugs threaten the financial sustainability of the National Health Service (NHS) with spending on branded medicines increasing by over 5 percent annually.

This, in conjunction with gaining traction with environmentally concerned customers, will benefit a business' brand, earning a good reputation by committing to building long-term sustainability and prioritising customers' needs.

However, all the necessary and stringent regulations within pharma mean virgin plastic cannot be ruled out, owing to the need to safeguard patient safety and medicine integrity. But PCR provides a way for the pharmaceutical industry to reduce and address its contribution to the plastics crisis the world finds itself in.

As the adoption of PCR gains momentum, it is essential to acknowledge that sustainable practises go beyond raw materials alone.

Holistic sustainability strategies encompass innovative design, responsible consumption and recycling programmes.

There are financial benefits that come with the investment into sustainable packaging because businesses are likely to enjoy a higher return of investments (ROI) due to rising demand and lower costs of manufacturing.

At the same time, consumers and other stakeholders must understand that PCR is not a silver bullet for solving plastic pollution. Complexities unique to the pharmaceutical industry limit its scope.

Furthermore, manufacturing cost-cutting will trickle down and benefit healthcare services. For example, according to research conducted by The London School of Economics, the

Responsible Strategies in the Face of PCR Challenges Unfortunately, the pharmaceutical industry is among the top global contributors to pollution and finds itself tiptoeing a

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delicate balance between striving to meet both stringent health and safety requirements set by regulatory bodies, and the expectations of environmentally concerned modern consumers.

Whilst other industries enjoy the freedom of prioritising design, aesthetics and sustainability in their packaging, the pharmaceutical industry must maintain health and safety standards as the utmost priority.

This presents a pervasive challenge for the pharmaceutical packaging industry. PCR-derived packaging has many limitations including compromised quality, process inconsistencies, application limitations and contamination, all inhibiting its viability as a universally suitable packaging solution.

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When applied to pharmaceuticals, this potential lack of 'purity' in PCR means the background of the material is undetermined or traceable. This uncertainty limits use cases for the product, making it unsuitable for various pharmaceutical products such as those that are injected into the bloodstream.

Although PCR materials are a trending solution to the plastics crisis, evidenced by the growing demand for them across packaging industries, supply shortages are a thorn in the side of manufacturers.

The cause of this shortage might be attributed to the fact that many people are ignorant of how to properly recycle plastics in the first place, including pharmaceutical packaging. Every week,

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GREEN VISION 1.85 billion pieces of plastic packaging are thrown away instead of being recycled in the UK. Not only does this lack of public awareness further contribute to the mounting global plastic crisis, but also creates a supply shortage for manufacturers of PCR. Addressing these knowledge gaps through comprehensive public awareness campaigns and educational initiatives, is therefore paramount to bridging the gap between demand and supply for PCR. Furthermore, contamination of recyclable plastics renders the waste useless as it cannot be used to create PCR. Contaminants come in the form of food scraps and oils which have not been adequately removed before consumers recycle them.

In the modern time-starved society, plagued by a culture of convenience and instant satisfaction, spending tine on washing out packaging waste before recycling is not a priority.

As with any seemingly ideal solution to a problem, due diligence and pragmatism must not be lost. The PCR supply shortage means that businesses too focused on riding the popular recycled materials trend do so while running the risk of adversely affecting the environment, which is counterproductive.

The use of PCR must be responsibly governed with sustainability in mind. Firstly, consideration of the waste hierarchy is essential and calls for the prioritisation of prevention of waste rather than having to deal with waste. The truth is that sustainability cannot be imposed on existing designs but rather designs need to be reimagined at the earliest stages of inception, incorporating reuse and recycle methods such as PCR. To achieve this, recycled materials need to be "designed in" at a percentage equivalent to current market availability and capability. This mitigates any risks of responding to increasing demand for recycled plastic only to inadvertently result in more virgin plastic being created to fill shortfalls.

There is a compromise to be had. Packaging that is partly recycled, such as medicine bottles made of 30 percent recycled plastic, still positively contributes to the battle against plastic pollution and has its virtues over 100 percent recycled packaging products in some instances.

The responsible approach to sustainability in packaging is to consider the entire life cycle of the production of all materials to be sure that an 'apples-to-apples' comparison is held, henceforth deciding how sustainability can be upheld on a project-byproject basis.

A Holistic Approach to Sustainable Packaging The use of PCR in pharmaceutical packaging offers stakeholders an opportunity to achieve their sustainability goals.

Taking a holistic approach to sustainability starts with materials being selected based on how much of an impact they have on the environment and how easily they can be reused or recycled into new products with as little waste as possible. This must be factored in from the very beginning.

The pharmaceutical industry has a role to play in addressing the shortage of PCR and supporting a pipeline for future use and production of PCR-derived packaging. Pharmaceutical

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packaging is recyclable in many instances, but communication on where and how to recycle medicine packaging remains limited.

Raising awareness in this area will promote the correct recycling of pharmaceutical packaging, bolstering the supply of PCR and, in turn, promoting the manufacture and use of PCR products across the industry.

Stakeholder investment and participation in recycling programmes present a further commitment to sustainability, positively enhancing consumer sentiment towards the industry.

Lastly, the pharmaceutical industry can 'clean up' its act by following a cyclical design process which factors sustainability into design throughout, minimising material wastage and product weight. In turn, this reduces the carbon footprint of products, prioritising efficiency in production and continuously taking part in and supporting research and development.

Innovation has given way to a new age of packaging called bio-based packaging. In 2022, the bio-based packaging market was valued at USD 7.92 billion, but it has been forecast that between 2023 and 2032 the market is going to show a CAGR of 12.5 percent reaching USD 25.86 billion.

Bio-based packaging products are manufactured with plant-based materials known as polylactic acid (PLA), polyhydroxyalkanoates (PHA) and moulded biodegradable pulp such as sugarcane pulp. However, on balance, it is important to realise that bio-based packaging is also not a silver bullet to the packaging pollution crisis of today.

Although bio-based packaging is derived from renewable biomass such as plants, not fossil raw materials, this does not guarantee their biodegradability or composability. Unless certified as home compostable, bio-based packaging requires very specific conditions within industrial composting plants in order to biodegrade and cannot be composted at home.

The resulting consumer mismanagement of bio-based packaging waste only serves to create another mountain to climb.

Although there is a long way to go with each solution coming with its own unique challenges, growing commitment and continued investment into sustainability research means the future of a cleaner pharmaceutical packaging industry is a hopeful one.

Steve Brownett-Gale Steve Brownett-Gale is a marketing professional with a career spanning both communications and products in B2B and B2C markets across manufacturing and services sectors. At Origin, in his role as marketing lead, Steve is responsible for positioning the company as a world-leading supplier of innovative and ground-breaking pharmaceutical packaging devices, as well as offering a unique and disruptive supply chain model.

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GREEN VISION Sustainability Efforts at Aurena

At Aurena Laboratories, we take sustainability seriously.

As a family-owned contract manufacturer specialising in medical device classified bag-on-valve products, we understand that sustainability is a strategic business priority. Since a few years, our commitment to sustainability is embedded in our operations, and we are confident that our focus on social, environmental, and economic sustainability aligns with both the expectations of our various stakeholders and the long-term growth of our business.

Today sustainability is at the core part of our business philosophy as we are trying to integrate sustainability across all levels of our operations, from the way we manufacture products to how we interact with our suppliers and customers. We use internationally recognised frameworks such as ISO 26000 and EcoVadis to guide and assess our sustainability performance.

Johan Jörnevik, Sustainability Manager at Aurena explains: “Sustainability is now an integral part of our business at Aurena.

It’s not just about compliance but about minimising our footprint while making a positive impact on both the environment and society.”

In recognition of our ongoing efforts in sustainability, Aurena has achieved a Silver rating from EcoVadis, placing us in the top 15% of companies assessed globally. This achievement reflects our commitment to responsible business practices across environmental, social, and ethical dimensions. However, we see this as only the beginning, and we are determined to further improve our sustainability performance in the coming years.

Environmental sustainability is one of our highest priorities. We are committed to using 100% renewable energy for our operations and are proud to have installed a solar power system that meets 30% of our energy needs. By working on reducing emissions through transport optimisation and energy-efficient production, we are working actively to reduce our carbon footprint.

Today, our largest carbon footprint comes from the use of virgin aluminium in the production of the aluminium cans used for our Bag-on-Valve products. In the coming years, we plan to phase out the use of virgin aluminium and transition to PCR (post-consumer recycled) aluminium.

For certain products, we are also exploring the possibility of using 'Green Aluminium,' where virgin aluminium is produced using renewable energy sources such as hydropower. These initiatives will significantly reduce our environmental footprint and align with our long-term sustainability goals.

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Daniel Lagerkvist, Production Manager describes: “Our production processes are designed with efficiency in mind, and we are seeking ways to minimise our environmental footprint. By transitioning to a circular economy, we aim to use materials such as recycled aluminum and recycled cardboard, while maintaining the high quality and safety standards our customers expect. As a contract manufacturer, we recognise the importance of working closely with our customers to achieve sustainability goals with tangible impact.

Our products are sold around the world, and it is essential that we and our customers are aligned on our sustainability initiatives.”

About Aurena Aurena Laboratories is founded from a strong family tradition and a history of medical technology innovations. Since the company was founded in the year 2000, the company has experienced constant growth, and Aurena now delivers products to major brands around the world.

Our core business includes the develop-ment, manufacture and marketing of liquid medical devices in spray format.

What sets us apart from many others is our long experience of bag-on-valve (BOV) packaging, which is used to package our products safely and hygienically.

The bag-on-valve technology offers several advantages for medical products. It's an airless packaging that protects the liquid product from contamination and can therefore achieve a long shelf-life. Bag-on-valve enable 360-degree dispensing. BOV products are pressurised with compressed nitrogen or air.

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GREEN VISION Environment and Climate At Aurena, we take our responsibility for the environment very seriously. We are aware that our decisions and actions have a direct impact on the world around us. That is why we are continuously working to integrate sustainability aspects into all parts of our business, from sourcing to product delivery. By putting the environment in focus, we work towards reducing our climate impact, optimising our resources and contributing to a sustainable future.

Environmental Policy An important part of decision-making and internal processes at Aurena is that we must always consider the environment and future generations. This is achieved through continuous improvements in the environmental field. We achieve this by: •

We work in a highly regulated industry and there are significant expectations of us from both authorities and customers. Aurena strives to meet and exceed these expectations.

We are certified according to ISO 13485, which ensures the high quality and safety of our medical device classified products. For the company's ongoing efforts in pharmaceutical manufacturing, Aurena intends to add additional GMP-certified operations and capabilities.

Our products are distributed worldwide, and we have established international relationships with pharmaceutical companies, medical device companies, pharmacy chains and pharmacy distributors worldwide.

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•

• •

Always comply with applicable laws and other relevant requirements that affect our business.

Integrate environmental considerations into all our decisions to minimise our emissions from transportation, energy consumption, components, raw materials, among other things.

Ensure a safe and secure working environment for our employees by promoting environmental and safety-related activities within Aurena.

Transparency in our communication about our environmental work.

Waste We work purposefully to ensure that the majority of our waste is recycled or reused. This is part of our sustainability work to reduce the amount of waste and unnecessary waste. Our waste is handled by qualified third-party or collection companies.

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Renewable Energy Our goal is for all energy consumption to be renewable. Since 2019, our electricity consumption has been 100% renewable, such as wind and hydropower. In 2023, the installation of a solar cell system began on Aurena's factory in Karlstad, Sweden.

The facility was completed at the turn of the year 2023/2024.

Geothermal Heating Our premises in Karlstad are cooled and heated with the help of geothermal heating, which utilises solar energy stored in the bedrock. This form of energy is constantly renewable and has a small environmental impact.

Water Consumption Water is a central part of our business, both as a component of our products and for cleaning our equipment. Water consumption, therefore, naturally increases as production increases. Responsible management of our water use is an important part of our sustainability work. Water is a fundamental component in many of our products and we work to minimise waste and optimise the use of this resource.

Chemicals At Aurena, chemical management is an important and prioritised issue. We always comply with applicable laws and regulations and to ensure safe handling, we have established procedures to prevent incidents and minimise risks.

Chemicals are used both in our laboratory operations and in our production. Safe chemical management is essential to maintain a safe and secure working environment and to minimise the risk of spills and other events that can negatively impact the environment. Before purchasing chemicals,

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a thorough risk assessment is carried out. Aurena strives to source substances that are safe for both humans and the environment.

Transporter During the last year we have implemented several measures to consolidate the flow of goods around the world which has led to both reduced emissions but also cost savings. There is also potential to reduce our carbon footprint by setting requirements or actively choosing more sustainable fuels for our transports.

Daniel Lagerkvist Daniel Lagerkvist is a key figure at Aurena and is currently serving a dual role as Production Manager and Manager of the People & Culture department. Within Aurena's management team, Daniel holds the overall responsibility for the company's sustainability efforts. He has many years of experience in leadership positions within the Swedish manufacturing industry. Daniel holds a Master of Science in Mechanical Engineering from Chalmers University of Technology.

Johan Jörnevik Johan Jörnevik holds a Bachelor's degree in Environmental Science and Safety from Karlstad University. He is driven by a strong passion for environmental and safety issues and has been the sustainability manager at Aurena since August 2023.

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GREEN VISION Commitment to Sustainability

Our motto at Nemera – ‘We put patients first’ – is the north star that guides us in our decision making across all levels of our business. I am incredibly proud of how we continue to help with the treatment of millions of people globally and make a positive difference in their day-today experiences. Our products save lives, improve living conditions, and empower patients. However, our sense of responsibility does not stop there. We recognise the role Nemera must play in addressing the major environmental and societal issues facing us all.

It is no good helping patients of today if our approach leads to negative impacts for people and the planet, now and in the future. This journey towards becoming a more sustainable company is ongoing and requires everyone at Nemera to play their part. Our 2023 ESG Report provides a snapshot of where we stand today on sustainability, our strategic priorities and objectives, and the progress we have made over the last years.

The importance of sustainability within our core business strategy also means that it is integrated across all levels of Nemera. Sustainability is overseen at the board level, with periodic reviews of our strategy, key performance indicators (KPIs), and progress on key activities, programmes and ratings.

Alongside this, we look to proactively engage and involve our employees with sustainability initiatives, recognising the role that everyone must play if we are to achieve our objectives.

This integrated approach is key for growing and deepening the positive sustainability impact we are having, and will continue to have, as a company.

As I look forward, we are fully committed to future proofing Nemera as a business in 2030 and beyond.

We are focused on minimising our environmental impact via our innovative and eco-designed products, while maintaining the highest possible standards of patient care. To achieve these and other goals, partnerships remain key. We welcome all stakeholders reading this report to engage further with Nemera on sustainability, so that we can effectively scale the positive impact of our work and, together, seek to leave a healthier planet for future generations to come.

OUR SUSTAINABILITY RATINGS & ENDORSEMENTS EcoVadis Our latest EcoVadis result reflects our desire to continually improve the ways in which we manage and report on sustainability. While maintaining our silver medal from 2022, we saw significant improvements across our assessment, including an overall score increase of eight points to 67/100. This jump placed Nemera within the top 11% of all companies assessed by EcoVadis this year – regardless of industry. We also improved

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specifically within the environment, labour and sustainable procurement pillars, while maintaining our score for business ethics. While delighted with this outcome and its reflection on the holistic integration of sustainability within our business, we are determined to strive for more.

CDP We submitted our data to the Carbon Disclosure Project (CDP) for the third time in 2023. CDP rates companies from A (best performers) to D (low performers) based on climate practices and efforts to mitigate and reduce their impact. We increased our score from B- to B, placing us above our industry average score (C) and demonstrating that we are actively addressing climate issues and steadily moving towards recognised best practice.

As with other third-party organisations like EcoVadis, our yearly improvements bring us pride but also a determination to seek further improvements and continue pushing our boundaries as a sustainable organisation.

UNGC We are thrilled to also share we committed to the United Nations Global Compact (UNGC) in 2023, the world’s largest sustainability initiative. Our participation in this initiative strengthens our commitment and alignment to the sustainable development goals, as we join a community of companies committing to embodying the 10 fundamental principles of the UNGC under the pillars of environment, human rights, international labour standards and anti-corruption.

Sustainable Procurement At Nemera, we believe that sustainable practices must extend far beyond our operations. This means recognising our duty to reach our suppliers and enhance sustainability through partnerships. Our objective is for all our suppliers to prioritise the environment and enhance the well-being of workers and communities. We also want our suppliers to continue integrating ESG in their governance frameworks to prevent ESG risks.

To vehiculate our objective through our upstream supply chain, we rely on the expertise and awareness of our procurement

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GREEN VISION environmental objectives. As we look ahead, our commitment is clear: we aim to source our materials from low carbon resins, while also enhancing eco-design and product reusability to drive our circularity ambitions and achieve our objectives on plastic recyclability and waste to landfill.

Additionally, we are also on the way to achieving our carbon reduction targets, which were approved in 2023 by the ScienceBased Target Initiative (SBTi). Our goal is to reduce the carbon footprint generated from our production activities and supply chain. These goals are embedded in our decision-making process as we prioritise sustainability and the long-term viability of our choices.

department. Our team participated in various training initiatives and workshops to improve Nemera’s ability to integrate ESG principles into our purchasing practices and assess supplier engagement in our sustainability approach.

Additionally, this year we introduced assessment and follow-up systems to onboard our upstream supply chain in our sustainability journey. An example of this is our EcoVadis engagement programme, where we encourage suppliers to undergo an EcoVadis assessment to rate their sustainability performance. This allows us to identify suppliers’ improvement areas and collaborate with them in continuous improvement initiatives to enhance their sustainability while preserving or improving their performance.

Our vision for 2024 is to embed sustainability further into our decision making and continue to select and assess suppliers with a focus on their carbon footprint and general sustainability engagement. Besides, we are dedicated to intensifying the sustainable part of our suppliers. To achieve these goals, our partners can expect Nemera’s continuous commitment and collaboration.

Environment At Nemera, patients come first. However, improving patients’ lives goes hand in hand with being more environmentally sustainable. That is why we understand how important it is to put sustainability in motion – our focus on sustainability is not just a business strategy, it is ingrained in how we all live inside and outside Nemera.

We do not want to just comply with environmental standards; we recognise our responsibility to our patients, who expect us to do better and we are supported by Nemera’s strong emphasis on Research and Development (R&D) to bring these ambitions to life. Our R&D department is now equipped to enhance sustainability and bring circularity into our products. Our latest innovation Symbioze™, an on-body injector platform, is now reusable, allowing us to improve patients’ injection experience and our product sustainability.

We continue to work toward our goals and use every development as a steppingstone to move Nemera towards our

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As a patient-centric organisation, we understand that people and their needs are continuously changing, and therefore innovation is part of our daily activities. Innovation comes in different forms. First, our products should maximise treatment efficacy to enhance quality of life for patients. Second, reducing our negative environmental impact is mandatory in a society trying to overcome a climate crisis – which also directly affects patients.

Therefore, it is our duty to consider these elements when designing products which benefit both our customers and our planet.

We started our innovation journey in 2007 by establishing an R&D department, allowing us to rethink our designs, processes and impact, and make better decisions. Understanding improvement hotspots through research is essential to achieve success, particularly as we operate in such a highly regulated industry. This foundation allows us to progressively consider our environmental impact, across both our operations and value chain, and is now a huge driver in the way we do business.

Carbon Footprint Audit Our first carbon audit of our key performance indicators (KPIs) in 2022 confirmed that our carbon tracking adheres to industry standards and verified our GHG indicators submitted to CDP with a limited degree of assurance. This assurance is part of our drive to provide patients, employees, and stakeholders with transparency over our climate performance. Our 2023 KPIs will similarly be audited in early 2024.

Climate Risk Assessment To better understand the risks posed by climate change to our activities, we re-conducted a climate risk assessment in 2023. Compared to past assessments, this year’s evaluation gives us a fuller picture of our climate risk scenarios. The report summarises the risks linked to our business activities, covering both physical and transitional aspects. Overall, the outcomes of this risk assessment will contribute to the development of an action plan that will focus on decreasing the impacts of both physical and transitional risks while also improving our ability to manage and mitigate against these challenges.

Reduce Commuting and Business Travelling Emissions We are in the process of developing a travel and commuting policy with the aim to reduce emissions by 10% and increasing train usage by 5%, by encouraging the use of public transportation and creating a monthly budget for electric vehicle use. We have also started providing a company bus for our employees at our manufacturing facility in Szczecin, Poland. In 2023, 102 out of 243 employees used our bus to travel to work, helping to reduce the GHG emissions associated with individual commuting.

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GREEN VISION Renewable Energy We are determined to obtain all our electricity from renewable sources by 2030. This includes our manufacturing facilities, where most of our energy is consumed. To help us in reaching this objective, this year we became members of RE100, a global initiative uniting businesses which are dedicated to achieving 100% renewable electricity usage. In 2023, our sites in Poland and Brazil also switched to 100% electricity from renewable sources.

A major initiative in 2023 involved upgrading the lighting system in our office building in Buffalo Grove, under the guidance of our Energy Committee. In practice, the lighting systems of our production store and offices were converted to LED lighting. This upgrade has led to a decrease in both our energy usage and greenhouse gas emissions, with estimated savings of 97,474 pounds of carbon dioxide (CO2) emissions and 491,610 tons of nitrogen oxides (NOx) annually.

Circulatory We recognise the efforts that the medical device industry has made to increase the use of sustainable materials. We are committing to and investing in bio-resins and materials that can be recycled and recovered.

At Nemera, circularity is central to our environmental efforts.

This means we are dedicated to making our medical products easier to recycle and less wasteful. Our R&D department focuses on understanding product impacts and creating eco-friendly designs.

Waste Management We have implemented several waste efficiency and performance programs, as well as partnerships, to help reduce and recycle increasing volumes over time. Our ISO 14001 processes and waste audits ensure our management approach is comprehensive and validated by expert third parties.

Eco-design and Bio-resins The production of drug delivery devices typically relies on fossilbased plastics and linear life cycles. This has severe environmental consequences as large amounts of non-recyclable waste are incinerated, while the disposal of these products harms local ecosystems and habitats, including soil, water and biodiversity.

At Nemera we continually explore materials that reduce our environmental footprint. We are looking to scale the use of bio-based resins in our medical containers, replacing traditional and carbon-intensive oil resins with more ecofriendly alternatives. Our research shows that by adopting bio-based resins, we can reduce our greenhouse gas emissions by up to 30% per device on average.

This applies to different Nemera products, including bottles, and caps, which demonstrate the versatility of bio-based resins. Additionally, despite having few impact transfers, the biobased resin offers the same quality as its original material equivalent. This year, our La Verpillière plant obtained Nemera’s first International Sustainability & Carbon Certification (ISCC Plus), which validates the use of bio-based, renewable, and circular materials. This certification underlines our commitment to renewable and circular materials in our products and manufacturing processes.

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Looking Forward to 2024 2023 was a year of great progress for sustainability at Nemera.

One of our biggest achievements is the completion of our first double materiality assessment, which will allow us to build a more holistic strategy that will fit the needs of everyone across our company. We are already seeing the benefits of a deeper understanding of the topics which are most important for both our own operations and value chain. Internal engagement on sustainability has never been higher, something which brings pride and encouragement for our work.

We have heard stories of how participants in our 2-Tonnes workshop have organised similar events for their families and friends, which is a sign of how we can positively scale our sustainability impact beyond our everyday working lives. We also hear conversations on sustainability in our daily work, facilitated by the training and awareness we are looking to raise on topics across all pillars of our sustainability strategy. These conversations are taking place everywhere in our company, with sustainability now a central part of conversations from top management to site level.

Strengthening our corporate governance in relation to sustainability was another major achievement along these lines and gives us an even stronger foundation from which to pursue our sustainability goals in the coming years. A welcome challenge that comes from this increased engagement, is that the more engaged our employees become on sustainability, the more they expect from us as a company.

This message reinforces our aim to never stand still on this topic, shown by our desire for continuous improvement in ratings such as EcoVadis and CDP, increasing the coverage of our ISO certifications and moving towards our 2030 objectives. We have set the foundation for continued success, and we are now focused on delivering this to patients, customers, employees, investors and all other stakeholders impacted by our work.

"Sustainability is at the core of everything we do at Nemera. From eco-design innovations to reducing our carbon footprint, we are committed to driving positive environmental and social change.

Together, we strive to create a healthier, more sustainable future for both our patients and the planet."

Sandrine Coutarel Nemera Global EHS Director

Volume 3 Issue 1

YOUR PARTNER FOR DRUG DELIVERY DEVICE SOLUTIONS

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AND COMBINATION PRODUCT SERVIC pharmanaturepositive.com

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Safe for the patient. Sustainable for the planet.

As climate change challenges our world, the pharmaceutical industry must rise. At SCHOTT Pharma, we’re driving the future with innovative, sustainable packaging solutions. Our focus: decarbonization, resource efficiency, and embracing the circular economy.

Committed to leading industry change, we work closely with customers and partners to reduce environmental impact without compromising patient safety. Only together, we can make an impact. Join us in mastering the decarbonization journey. schott-pharma.com/en/sustainability

Visit us at the CPHI Milan, Hall 20 Booth 20C16, to learn more!