Introduction
The pharmaceutical industry stands at a critical crossroads where the imperative to save lives must align with the urgent need to protect our planet. As climate change emerges as one of the most pressing challenges of our time, the healthcare sector is being called upon to transform its practices and embrace sustainability without compromising on the quality and efficacy of life-saving medications. This transformation is not just an environmental necessity but also an economic opportunity that promises to revolutionize how we develop, manufacture, and distribute medicines for the benefit of both human health and planetary wellbeing.
Climate change is the most significant health threat to modern society, and the pharmaceutical industry faces sustainability challenges like every other industry. Even though much of the pharmaceutical industry's output saves and significantly improves the quality of life for billions of people, this cannot come at any cost to the planet. Recently, health agencies, such as the NHS, have set ambitious net zero targets, and as medicine accounts for 25% of NHS carbon emissions, the pharmaceutical industry has a crucial role to play in tackling this threat.
CPI's Medicines Manufacturing Innovation Centre has a mission to revolutionise pharmaceutical manufacturing through the development of innovative new technologies. It uses its 'Grand Challenge' model to de-risk pharmaceutical manufacturers' adoption of these technologies. By integrating emergent technologies into production processes, companies can reduce their environmental impact and create more sustainable drugs.
Manufacturing Pharmaceutical Products
The pharmaceutical manufacturing process represents one of the largest contributors to medicine's overall carbon footprint through its intensive use of energy and raw materials. Creating pharmaceutical products requires handling highly sophisticated molecular compounds that must be precisely formulated to ensure safe and effective patient treatments. This precision manufacturing process naturally requires substantial material inputs and energy consumption throughout production cycles.
To address these environmental challenges, pharmaceutical companies are actively implementing greener chemistry practices across their operations. These initiatives include replacing traditional solvents with environmentally friendly alternatives, optimizing manufacturing conditions to minimize waste while maximizing production yields, transitioning to renewable energy sources for facility operations, and selecting chemical reagents that pose reduced environmental risks. Additionally, the industry is embracing advanced digital technologies to revolutionize product development processes and improve overall manufacturing efficiency.
In Grand Challenge One, we are transforming how we make oral solid dosage medicines (OSD) by developing a novel digitally twinned continuous direct compression (CDC) platform. OSD products dominate the global market, with a 53% share reported in 2024. CDC offers several advantages to tablet manufacture when compared to traditional batch manufacturing techniques:
60-70% Reduction in Facility Size 30-50% Reduction in Manufacturing costs 69% Reduction in Energy Consumption - environmental benefit
When Janssen switched an OSD product from batch to continuous manufacturing, they reported a 70% reduction in manufacturing footprint and a two-week production time reduced to one day.
CDC is, therefore, a truly flexible way to manufacture tablets. The ability to adapt the production output to meet the demands of the current market supply, rather than a predicted forecast, eliminates waste and results in a lower environmental footprint.
Grand Challenge Three targets production of oligonucleotides, one of the most exciting emerging patient treatments. With the ability to target previously 'undruggable' diseases, they are moving from limited application in rare diseases to chronic conditions affecting millions. However, the pharmaceutical manufacturing process is complex, challenging and consumes vast quantities of solvent. At the Medicines Manufacturing Innovation Centre, we are working with innovators, academics and industry to develop and industrialise technologies to reduce or, more radically through biocatalytic approaches, eliminate the use of organic solvents in oligonucleotide manufacture.
Developing medicine
Bringing a new drug from initial concept to market typically takes 10-15 years, involving multiple complex phases including discovery and development, preclinical research, clinical trials, and regulatory approvals. Creating a robust and reliable manufacturing process is essential before product launch. However, process development presents significant complexity and demands substantial resources. The average cost of developing a typical drug and bringing it to market is estimated to be $1.4 billion, while nine out of every ten drugs that enter Phase I clinical trials ultimately fail to receive approval for patient use.
Consequently, manufacturers face a continuing dilemma about the amount of resources and effort to put into process optimisation throughout the development of a new medicine. Too much effort too early can be wasted if the drug experiences problems in clinical trials. However, delaying development can lead to the risk of either delaying product launch or launching with a sub-optimal process that can cause reputational damage to the product. Using digital twins to accelerate process development and create a more effectively controlled manufacturing process is one option to shorten process development time and de-risk the development of a robust supply chain. Digital twins can help focus process development on the areas of highest uncertainty and de-risk equipment choices, allowing more timely capital investment decisions. Grand Challenge One has developed a digital twin for continuous tablet manufacture. Studies estimate that an effective digital twin can reduce the process development burden by around 70%, introducing significant resource savings and reducing the carbon footprint of process development.
Medicine supply chain
Medicine supply chains are complex, involve multiple locations, and can be inefficient. Unused medication accounts for significant waste within the NHS, estimated at $375 million annually. The problem of waste is particularly acute in supply chains supporting clinical trials.
By their experimental nature, clinical trials are unpredictable. Many factors influence the course of a clinical trial from rates of patient incorporation at different trial centres to changes to trial design in response to clinical data. The problems that this unpredictability creates are that, unless the pace of the clinical trial is slowed, supply chains cannot respond quickly enough to the changes in demand, meaning significant material is prepared at risk and consequently wasted when not needed for the trials or when it expires. It is estimated that around 50% of the material prepared for clinical trials is wasted. In Grand Challenge Two, we are developing innovative approaches to clinical trial supply, breaking paradigms on how a packing line can be operated and digitising the batch release process to allow very small batches of product to be manufactured without overwhelming the quality system.
Conclusion
The journey toward sustainable pharmaceutical manufacturing represents one of the most important challenges and opportunities facing the healthcare industry today. As we have seen through the innovative work at CPI's Medicines Manufacturing Innovation Centre, the integration of cutting-edge technologies such as continuous direct compression, digital twins, and biocatalytic processes is not just reducing environmental impact but also improving efficiency, reducing costs, and accelerating drug development timelines.
The pharmaceutical industry's commitment to sustainability goes beyond corporate responsibility—it is essential for ensuring that the medicines that save lives today do not compromise the health of future generations. The impressive results achieved through these Grand Challenges, from 69% reductions in energy consumption to 70% decreases in manufacturing footprints, demonstrate that environmental stewardship and pharmaceutical excellence can go hand in hand.
As the industry continues to innovate and embrace these transformative technologies, we move closer to a future where life-saving medications are produced with minimal environmental impact, where waste is eliminated through smart supply chain management, and where the development of new treatments becomes more efficient and accessible. The path forward requires continued collaboration between academia, industry, and regulatory bodies to overcome the remaining challenges and unlock the full potential of sustainable pharmaceutical manufacturing.
Pharmaceuticals have transformed society and will continue to impact human quality of life in the future positively. However, the benefits of drugs must be balanced with their effect on the global environment. There are multiple opportunities for innovation to improve the sustainability of pharmaceutical production and supply, and the work at CPI's Medicines Manufacturing Innovation Centre is turning opportunities into reality.