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Press Clipping / Jul 19, 2023

Net-Zero Pledge: CDMOs Go Greener

Contract Pharma, 19 July 2023

In the year 2021, when COP26 was held in Glasgow, Sterling Pharma Solutions came out announcing an ambitious target: to reduce the CDMO’s overall emissions by 50% by 2025 and by doing so, joining the international community’s fight against climate change.

The CDMO Recipharm expanded its pressurized metered dose inhalers (pMDI) product development the following year to accommodate the switch to new propellants, which have 90% to 99.9% lower global warming potential than HFA134a.

In the same year, WuXi STA won top scores from EcoVadis, a provider of business sustainability ratings, for their API and formulations factories located in China.

Again, in January, Samsung Biologics was awarded the 2022 Sustainable Markets Initiative’s Terra Carta Seal in recognition of its commitment to achieving net zero greenhouse gas emissions across its direct operations and supply chain by 2050 or earlier.

Similarly, Cytiva says its goal is to eliminate polystyrene from the company’s packaging materials and supply chain by 2025.

These are just a few examples of a growing trend.

A number of CDMOs are accelerating their environmental drive setting themselves far more ambitious targets than these as sustainability goals are now becoming one of the most urgent business strategies facing pharma companies.

Presently, analysts say that there is a move away from sustainability being seen as something that is nice to have, to something more fundamentally important to businesses.

"Sustainability commitments are no longer just desirable," says Jon Peers, director of sustainability at Hovione. "They are becoming mandatory, both directly by our regulatory authorities and indirectly by the regulatory and financial requirements faced by our customers."

Hovione, a leader in spray drying and particle engineering, became a Certified B Corp in 2017 integrating an innovative community of companies that use the power of business to solve social and environmental problems.

Pharma’s outsized impact

Medicine making leaves an environmental impact which is quite massive. Estimates show that the pharmaceutical sector is accountable for as much as 4.4% of worldwide emissions—and if no action is taken—its carbon dioxide, a greenhouse gas (GHG), emissions are predicted to triple by 2050.

Not only manufacturing but the distributing and transporting of medicines from the factory to the patient also carries a substantial environmental footprint.

According to the Sustainable Markets Initiative’s (SMI) “Decarbonizing Healthcare Supply Chains” whitepaper, the biopharma industry is responsible for 4–5% of global GHG emissions, with most of its carbon footprint coming from supply chain, manufacturing, retail, and logistics.

Having felt the heat, many leading pharma companies are already ahead of the curve on the path to net-zero carbon emissions. They have made carbon neutrality and net-zero pledges, some for as early as the next decade.

Sustainability metrics: High on the agenda

CDMOs demonstrate a strong determination to reduce their carbon emissions as environmental performance is being added to the list of demands by their clientele.

Industry reports show that full waste recycling, green power percentage and green chemistries currently play a crucial role during negotiations between pharmaceutical companies and the CDMOs.

These “sustainability metrics” are becoming increasingly important even as technology, track record, capacity, and cost are still the most important criteria for selecting CMOs/CDMOs.

"Recognizing our commitment and progress made towards our sustainability targets, clients will seek out not only providers of CDMO services but also those companies with the competence to execute these services in harmony with the client’s respective sustainability goals," says Paul Zuechner, director, sustainability and reliability engineering, pharma services, Thermo Fisher Scientific.

Thermo Fisher, which offers end-to-end solutions to small molecules as well as biologics, announced an acceleration of the target to reduce scope 1 and 2 GHG emissions to more than 50% by 2030.

Zuechner maintains that the increasing focus on sustainability, resource and decarbonization quantifications is now elevating sustainability towards an equal project deliverable on par with cost, quality, and timelines.

The sustainability initiatives by CDMOs are not only driven by customer preference but also by regulatory requirements, according to Peers of Hovione. Regulated and standardized reporting is there. The European Corporate Sustainability Reporting Directive (CSRD) together with the European Sustainability Reporting Standards (ESRS) is significantly raising the required levels of compliance.

On top of this, businesses must meet their stakeholder’s requirements to provide material information that stands up to scrutiny.

Headquartered in Loures-Portugal, Hovione believes that it is simply not possible to meet the challenging goals that have been set by the companies themselves on sustainability without further innovation, particularly through process intensification and the greening of pharmaceutical intermediate and API manufacturing.

Safety via process efficiency

Without question, manufacturers are aggressively pursuing various strategies to enhance processes as it becomes a business imperative for the service providers.

"Olon tries to optimize plants' performances, in order to reduce the amount of energy, materials and natural resources they need,'' says Giorgio Bertolini, senior vice president of R&D, Olon Group, a global leader in the development and production of APIs, headquartered in Milan, Italy.

Olon is working on cutting-edge R&D processes applied both to chemistry, in terms of flow chemistry, photochemistry, and electrochemistry, and to biotechnologies. Investing in and developing technological advances allows the organization to combine well-established practices with new ones, to guarantee efficient and successful manufacturing processes, at the same time ensuring safe, fast and cost-effective commercial processes.

"We consider climate protection and the related reduction of GHG emissions to be a top priority," emphasizes Bertolini. To increase efficiency and reduce the energy required for production, especially in the functioning of reactors, Olon is implementing several continuous manufacturing processes, investigating both the flow chemistry approach and the continuous stirred tank reactors (CSTR)

These approaches entail leaving no batch reactors with loading and unloading phases but keeping constantly active production units—either microreactors or small classical reactors. The outcome is that, at the same levels of production, continuous manufacturing processes can reduce the footprint of the manufacturing process in comparison with standard methods.

This innovative production technique, he explains, enables a double positive impact in terms of sustainability. Indeed, it allows for the use of smaller amounts of material for the unit time, therefore resulting in increased local temperature control and in the possibility to avoid extreme temperatures, making the manufacturing process less energy intensive. It also provides greater safety for operators.

The industry is now facing a change of paradigm, avers Bertolini, in which there is a continuous exchange of knowledge and information between the chemical and engineering sectors, which eventually results in the creation of new specific know-how and business synergies.

Olon started constructing a new facility at its Rodano site (Milan, Italy) dedicated to ultra-potent compounds, used for antibody-drug conjugates (ADCs).

Circular business models that combine a responsible use of natural resources and raw materials with a responsible waste management approach are what Olon strives to promote, according to Bertolini.

Greening the supply chain

To reduce effluents and design safer alternatives to hazardous processes organizations extensively explore the use of safer and more sustainable chemicals.

This green chemistry approach can minimize the risk of impact on the environment to a great extent.

Olon, for instance, is focusing on green chemistry projects for the replacement of chlorinated solvents and the reduction of critical substances which could be particularly toxic, especially in new manufacturing processes.

Not only in manufacturing, quite a few companies are investing in greener biofuels (rather than diesel) for vehicles. As mentioned, distributing and transporting medicines from the factory to the patient also leaves a large carbon footprint. Temperature-sensitive products are loaded onto refrigerated vehicles to maintain cold-chain which require a considerable amount of energy to power.

Environmental credentials are now integral to all supply chain decisions. There is almost a universal consensus on this approach, shows the CPHI sustainability sentiment index.

In data released ahead of CPHI Frankfurt 2022, 95% of industry executives suggest it is either “important” or “extremely important” (52%) to have visibility on supply chain partners.

Scope 3 emissions: Key challenge

In comparison to the scope 3 tally that falls not within the organization's boundary, scopes 1 and 2 emissions are relatively minor. However, within these scopes, electrical energy consumption in manufacturing and the fugitive emissions from hydrofluorocarbons (HFC) released during pMDIs product lab testing are the highest.

pMDIs and anesthetic gases can be particularly serious for global warming. The UK and several countries in the EU block including Belgium, and the Netherlands are now promoting dry powder inhalers in prescription guidelines. Meanwhile, the common general anesthetic desflurane is being replaced by lower-carbon alternatives in countries like Sweden.

Scope 3 emissions, however, make up the majority of the pharma sector’s carbon footprint. Even though many CDMOs have set ambitious targets like striving for carbon neutrality across the entire value chain already by 2030, many are still simply focusing on scope 1 and 2 emissions.

Observers say that this is largely because the need for sustainability in the pharmaceutical industry has become more apparent only in recent years.

Another concern is the cost factor.

According to Peers of Hovione, decarbonization costs in particular can be very expensive and require strategic planning and commitment from senior management to meet associated capital and operational costs.

The sustainability challenge, he says, needs to be considered throughout the drug development life cycle, starting from simple assessments against sustainability principles and metrics early on and growing in detail and robustness as the drug progresses through the cycle.

Shift in focus

Experts, however, see a shift across the industry. Discussions about sustainability are taking place at the highest levels. An increasing number of pharmaceutical companies are prioritizing it when discussing projects with their CDMO partners.

"Be it the fulfillment of new technical capabilities, increased production capacities, advancing regulatory compliance and now sustainability target introductions—it’s natural for us to solve for and achieve our customers’ product development, manufacturing, and corporate goals in partnership,” says Zuechner of Waltham, Massachusetts-headquartered Thermo Fisher.

It will be essential for drug makers and their CDMO partners to work together on questions of sustainability, and to be ready with a sustainability agenda before starting to work on the project, in the coming years.

It is important for CDMOs, says Peers, that their clients and suppliers share the same vision of a more sustainable industry as collaboration across the value chain is key to leveraging knowledge and driving change.

Read the article at contractpharma.com

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The podcast "The Next Discovery" is a six-episode series created by Observador, a leading portuguese digital newspaper and radio station, in partnership with Hovione. And what if some of the scientific discoveries that can improve the lives of millions of people were happening right now in Portugal? The Next Discovery. Listen to the first episode of the podcast here, featuring Diane Villax, co-founder of Hovione. [English transcription] Welcome to The Next Discovery. This is a series of conversations, created in partnership between Observador Lab and Hovione, an international pharmaceutical company of Portuguese origin, that will open the doors to its world and share real stories of science, innovation and global impact. Over six episodes, we will meet the people behind technologies that help develop and manufacture innovative medicines for the world’s largest pharmaceutical companies that improve the lives of more than 80 million patients every year. I am Nelson Ferreira and, in this first episode, we will discover how an unlikely story, which began in a basement in Lisbon, became a story of global leadership. To talk about this legacy, I have the honour of welcoming Diane Villax, co-founder and non-executive board member of Hovione, who at the age of 91 remains a living witness to this journey. Nelson Ferreira (NF): Welcome, Mrs Diane Villax. Let us begin our conversation in 1959. Hovione was born in an unlikely way, in a basement in Lisbon, founded by your husband, Ivan Villax, by you and by two other partners. How did you manage family life and, at the same time, the birth of a pharmaceutical company, all in the same space? I imagine that created some interesting logistical challenges. Diane Villax (DV): From the beginning, we decided that we would manufacture raw materials for the pharmaceutical industry, that is, the active ingredients of medicines. We had no money, so it had to start from our home, which was in a residential neighborhood in Lisbon. Right from the start, we divided the tasks. My husband, a brilliant Hungarian chemical engineer, would be the inventor, the producer and the salesman, while I would take care of all the administrative side: imports, exports, accounting and banks. I kept those responsibilities for at least 30 years. At the same time, we also thought about the values that would guide us over this long period: transparency, innovation, the pursuit of excellence and great consideration for everyone who would come to work with us over the years. NF: Very early on, your husband made it clear that Hovione would not compete on low price, but rather on quality and on solving complex problems. What was it like to apply this principle of rigour when resources were still scarce? Especially because, from day one, it always seems to me that your objective was global. The world would be your market. DV: From the beginning, we felt that Portugal, with a population of 10 million people, would not be a very significant market, and that the world would be ours. Perhaps we were a little naïve, because we were entering a global market that was already quite sophisticated. But the decision was made and we moved forward. We moved forward and were fortunate that Japan discovered us quite quickly. They came knocking on our door, because of course we did not have the means to knock on theirs. At that time, they did not manufacture; they only formulated, so they needed to buy raw materials. My husband had invention patents for independent processes and there were long discussions. They felt that our technology was good, our IP was very robust and our quality was excellent. This led to a cooperation that lasted 10 or 15 years and was very profitable for both sides, I believe. NF: In the 1980s and 1990s, Hovione took a more significant leap forward. What were the decisions, the technological bets or even the moments of greatest courage that allowed this small Portuguese company to become a leading multinational? DV: In 1982, after a successful inspection by the FDA, the regulatory authority in the United States of America, we entered the American market with our generic doxycycline antibiotic. The inventor’s patent had already expired and we had an independent manufacturing process. It was a huge, demanding and competitive market, but one that respects good service and quality. And it was indeed a major leap, because the market was so large that we had no real sense of what it would mean, and demand was much greater than what we were able to produce. I remember, it must have been the summer of 1983, many people probably had to postpone their holidays to the autumn or winter, because missing delivery deadlines was not an option. Later, in the 1990s, we entered a new business area: services. We realized that large American pharmaceutical companies, as well as small biotechs, were increasingly inclined to outsource the development work for new molecules. This is a very long period, which can take four, six or even 10 years — the development process for new molecules before they are approved by regulators and become commercial products. So we began to offer this development service, and it went very well. From there, we developed new technologies, such as spray drying, for poorly soluble molecules, because this could greatly increase their bioavailability. Today, this services area is our largest business segment. NF: Hovione today works with 19 of the world’s 20 largest pharmaceutical companies. How do you maintain the agile, pioneering spirit that was born in that basement, when today the company has 2,600 employees, more than 300 scientists, and has even become the largest private employer of PhDs in Portugal? DV: Agility has to be maintained. For example, during the pandemic, we suddenly received large, unexpected orders to manufacture a component of Remdesivir, which was the product authorized to help Covid patients. So agility has to be maintained, and we always maintain our quality. Today, with more than 60 years of history, clients come to us because they know they can count on our quality and on our responsibility to produce and deliver on time what they order. NF: There is another impressive figure here. Your products reach 80 million people every year and Hovione participates in up to 10% of the new medicines approved annually by the FDA in the United States. When you look at this impact, do you feel that the dream of 1959 has been fully achieved? DV: I think it has been far exceeded. When we founded Hovione, my husband, who was a scientist, simply wanted to have his own laboratory. But he never imagined that we would develop in such a way that, today, we are sought out by major international pharmaceutical companies, which frequently come to us. NF: This is a series about science, but it is also about people. And the rigour, ethics and long-term vision that Diane always brought to management are still present at Hovione. What message would you leave to the scientists who join Hovione today with the mission of finding the next discovery? From what I understand, Diane makes a point of welcoming them whenever they join the company. DV: Yes. Four times a year, twice in English and twice in Portuguese, I speak to the newcomers at Hovione, giving them a very brief account of our journey, our values, our objectives, our dreams, the challenges we faced and how we overcame them to get to where we are today. And I always recommend that anyone who joins this company must work with passion. They must work with passion and always remember that our work is to produce medicines for those who need them. We have the privilege of serving patients. We are a company that works for society. I think “In it for life”, which is our motto, has a lot to do with us, because we have been here for 67 years as a family company, and that is how we intend to continue for many good years to come. Above all, in the healthcare sector, there is a great advantage, because we can look at the long term. We do not have to think about stock market results every quarter, as public companies do. And, on the other hand, we are here precisely to give life to those who need it. “In it for life.” NF: At the age of 91, how does Diane herself maintain this passion and continue to make long-term plans? DV: Because I was a founder of this company. I see it progressing and developing successfully, so it is a joy for me. And I have a large family coming after me. I have six grandchildren and seven great-grandchildren, and I hope to leave the company to them so that they can continue it as I managed it. NF: That is truly inspiring. Mrs Diane Villax, thank you very much for sharing the memories and inspiration of this legacy, which remains very much alive. It was a privilege. This was the first chapter of The Next Discovery. In the coming weeks, we will continue to open the doors of Hovione to discover how Portuguese talent is leading the world, from complex chemistry to particle engineering, from respiratory therapies to next-generation biological medicines. You can listen to the next episodes on observador.pt and on your usual podcast platform.

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Podcast “The Next Discovery” (EP1) - From a basement in Lisbon to global impact

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Hovione is bringing momentum to the intranasal field after announcing that its lead single-use nasal dry powder device, developed in collaboration with Industrial Design Consultancy Ltd (IDC), is now available for commercial partnerships. The milestone marks the transition from prototype to a fully integrated intranasal drug delivery platform that spans Hovione’s end-to-end partnership capabilities–from API synthesis through advanced formulation and particle engineering to drug product manufacturing, including device supply and advanced analytical tools for nasal performance characterization. The platform’s single-use device is designed to be manufacturable at scale and to leverage existing advanced particle engineering and drug product manufacturing capabilities, a practical advantage that can shorten timelines to clinic and commercialization while reducing development risk and cost. The device’s patented mechanism supports targeted nasal deposition, including access to the upper olfactory region. This enables rapid systemic absorption and potential nose-to-brain delivery pathways that are increasingly important for CNS and emergency-use indications. Beyond the single-use format, Hovione and IDC are advancing a multi-dose variant to broaden applicability across dosing regimens and therapeutic areas. The collaboration is backed by an intellectual property portfolio and initial patent grants, positioning the platform as a turnkey option for pharma partners seeking a single integrated supplier for both drug substance and device. This development arrives as intranasal delivery gains traction for systemic, CNS and rapid-onset therapies. This is precisely the focus of the upcoming 4th Nasal Formulation & Delivery Summit, for which Hovione is a key sponsor. The annual summit unites formulation, delivery and product development leaders to tackle drug-device compatibility, translational preclinical models, and strategies for scalable, regulatory-ready intranasal programs. Hovione’s recent progress will be highly relevant to attendees looking to de-risk nose-to-brain and systemic intranasal programs. Read the full article at News-Medical.net

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Every year, the largest bank in Portugal, Caixa Geral de Depósitos recognizes some of Portugal’s brightest young minds through the Caixa +Mundo Awards, providing nearly €800,000 in scholarships to students as they pursue higher education. In this year´s edition, Caixa named the award bestowed upon students pursuing science for Diane Villax. This prestigious honor places Diane Villax among the award’s namesakes – a distinguished group of prominent personalities who have made notable contributions to Portugal´s socio-economic, cultural, political and scientific development over the last 50 years, such as António Ramalho Eanes, Mário Soares, José Saramago, Sophia de Mello Breyner, Leonor Beleza, Elvira Fortunato, Rui Nabeiro, Américo Amorim, and José Manuel de Mello. Diane Villax will also honor the seven scientific award winners by personally meeting with each of them, and following their journeys as future innovators and leaders. But this honor is about far more than one individual. It is a celebration of an entire organization and the people behind it. For 67 years, generations of dedicated teams have worked together with passion, purpose, and excellence to manufacture life-saving medicines and advance science that has a real impact on people. This recognition belongs to all of us.

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