Press Room

News / Feb 03, 2021

The Case for Sustainable Accounting Standards

EU Presidency: Informal Meeting of Ministers Responsible for Research

3 FEBRUARY 2021 - Belem Cultural Centre - CCB, LISBON - (online event)

The Case for Sustainable Accounting Standards

When the planet faces big issues, scientists are the first to flag them, the first to understand them, the first to design solutions – sadly science is seldom at the table when business decisions are taken.

When the issues are simple, such as the ozone hole above Antarctica, scientists can get decision-makers to understand and act and we have Science to thank for the Montreal protocol: 20 years elapsed from discovery to inverting the trend – this speed is possible when the problem is simple: a single chemical reaction -ozone and chlorine- and a single culprit – man-made CFC gases. Climate change is very complex, there are multiple causes, the magnitude of change needed is massive and therefore cannot be solved without a transversal approach.

Scientists are not able to influence decision-making because they do not speak the language of business. Companies, CEOs, asset managers, shareholders, funds march to the tune of profitability, their language is that of financial performance – today’s accounting standards ignore externalities and measure business profit not accounting for the good and the bad impacts of business on society and on the environment.

Sustainable accounting standards that measure profitability adjusted for social and environmental impact is the necessary new common language if we are to ensure scientists, business and other stakeholders understand each-other. If we do not measure, we cannot manage. CFOs don’t know what is a mole of a newton, as much as most people in this room might not know what is EBITDA or an impairment. We must measure unambiguously the true and complete value of business. This measure of value added corrected for sustainability can connect to a measure of sustainable GDP of a city or of a country, which in turn can connect with the value of the world's ecosystem services and natural capital. Tracking this performance over time will allow to assess the trajectory of the health of our planet.
Sustainable accounting standards will drive business to hire new skills. Finance and controlling areas will recruit scientists, engineers, anthropologists, sociologists... Over time the Chief Financial Officer will see its role evolving to that of a Chief Value Officer.

If business adopts sustainable accounting standards, executives and shareholders will know the complete extent of their impact and the liabilities they face from exposure to climate change. No one can then plead ignorance. Taxation can take into account social benefits and environmental costs thereby driving desired behaviors. No amount of Science Based targets and Mission Oriented R&D projects can ever come close to the impact on Climate Change that Business harnessed by the right accounting standards can deliver by doing its day-to-day work in a manner that considers the people and the planet. Sustainable accounting standards will allow the market forces to drive decisions in the right direction.

Putting a man on the moon by the decade’s end, may be more inspiring than making every company in the EU to comply with Sustainable Accounting Standards. This may come across as a small step for the EU Commission to take, but it would be a giant leap for the planet.

How could Horizon Europe spur the innovations necessary not only to embrace sustainable accounting practices, but also make it possible for economic, business and investment actors to evolve the underlying logic of market capitalism to value natural, social and human capital on par with financial? Could the EU lead the world in this evolution during next 10 years?”

Guy Villax
Lisbon, 3rd February 2021

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Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization. Read the full article at PharmTech.com

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Formulation Development/Drug Product Manufacturing Hovione Completes $46-M Tablet Mfg Facility Expansion Hovione, a CDMO of drug substances and drug products, has completed an expansion of its tablet development and manufacturing center at its main global campus in Loures, Portugal, adding 25% more commercial-scale batch tableting capacity for oral solid dosage products. The expansion strengthens integrated manufacture of amorphous solid dispersions by spray drying and tableting at a single site. The recently inaugurated expansion completes an investment cycle of more than EUR 40 million ($46 million). Hovione expanded its batch tableting capacity by adding an additional line mirroring the original unit across every local operation: dispensing, blending, dry granulation, tableting, and film coating. The mirrored configuration reinforces capacity at the 300 kg to 400 kg batch scale and provides both redundancy and like-for-like product transfers between lines. Supporting areas, including in-process control and staging space sized to the increased production capacity, were also added as part of the expansion. Read the full article at DCATVCI.org

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The company is building out more than 200,000 square feet of space in New Jersey. In April, Contract Pharma had the opportunity to tour Hovione’s expanded manufacturing facility in East Windsor, NJ. The company is planning a formal ribbon-cutting this fall; before that, we got an inside look at some new features. Having established United States operations in 2002, Hovione now has more than 200,000 square feet of space in New Jersey. This will be developed into a large, integrated campus in the next five to ten years. Overall, the company’s recent NJ expansion, which began in 2025, has tripled its total spray-drying capacity in the U.S. Future Facility Upgrades A 125,000-square-foot greenfield acquired by Hovione at the East Windsor campus will eventually be a large-scale production site. This includes enhanced quality control and R&D capabilities. Together, all this adds to Hovione’s stable of manufacturing sites, R&D centers, and other offices spread across three continents. Key to the expansion is a targeted reduction of Hovione’s carbon footprint by 40% by the year 2030. Part of this goal is embracing new and/or changing solvent types to help meet sustainability standards. Additionally, the company says automation that has been put in place at its Portugal site will be replicated in NJ. Hovione Aligns NJ Operations At the Drug, Chemical & Associated Technologies Association (DCAT) Week in New York in March, Contract Pharma met with Hovione. There, David Basile, Vice President of Technical Operations—Americas, further illustrated the New Jersey expansion. “Hovione aims to build an equivalent manufacturing network, where clients can go to any site across the globe,” Basile said. “The design of the facility has been well-thought through with material flows [and] gravity-fed processes. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets.” Ultimately, with these moves and a strategic partnership model, Hovione aims to provide customers an opportunity to co-invest and access the company’s proprietary knowledge and assets to accelerate programs and create long-term value. Read the full article at ContractPharma.com

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