Forging a more sustainable pharmaceutical value chain 20th October 2023
By Dr. Jamie Unwin, Vice-President of Strategic Insights, Nanoform
Climate change is perhaps the greatest global health threat of our time, precipitating extreme weather events and worsening air quality.
The impacts of climate change also affect the spread of infectious diseases, with variables such as warmer temperatures and increased rainfall creating more favourable conditions for pathogens. As such, the pharma industry has a role to play in safeguarding human health and well-being by adopting a planet-centric approach. Companies have a responsibility to reduce the environmental harm caused by pharma and respond to the growing demand for greener medicines. Many have seized the initiative, with major pharma companies such as Amgen and AstraZeneca working to achieve carbon neutrality within the next ten years or Merck, which is working to achieve it by 2025.
At every stage of the development journey, companies have room to reduce the environmental impact of their processes: from the initial R&D phase, where a vast range of drug candidates are gradually whittled down; to manufacturing; and finally to patient use, where poor compliance with prescribed treatments can lead to waste. The key to unlocking this sustainability potential is embracing innovative, green technologies such as nanoparticle engineering and AI. With the latest tools at their disposal, companies have the power to re-examine their processes and drive significant reductions in both emissions and waste.
One way to improve the overall sustainability of a drug candidate is by enhancing its bioavailability – i.e. the proportion of a drug that reaches systemic circulation when introduced to the body and is able to contribute to a therapeutic effect. Poor bioavailability is highly prevalent among new drug candidates and a common cause of drug development failure.
Higher bioavailability can mean a lower dosage is required to achieve the same therapeutic effect, thereby reducing the overall manufacturing footprint of a given medicine. A study led by researchers from the U.S. Environmental Protection Agency and the University of Washington corroborated this, identifying lower dose pharmaceuticals as a means to reduce the environmental damage caused by medicines.
To enhance bioavailability, approaches such as spray-drying of amorphous solid dispersions (ASDs) are commonly employed. However, pharma companies should carefully consider the environmental impact of such techniques. Spray-drying of ASDs can be wasteful, utilising large quantities of polymers and environmentally damaging organic hydrocarbon solvents. This is especially significant as research suggests that organic solvents make up 60% of mass consumption in the pharmaceutical industry.
Nanoparticle engineering technology offers an alternative, greener approach. The technique operates on the principle that reducing particle size increases specific surface area. This leads to improved solubility and absorption in the gastrointestinal (GI) tract, and hence, increased bioavailability.
An example of an environmentally-friendly nanoparticle engineering approach is Nanoform’s proprietary Controlled Expansion of Supercritical Solutions (CESS) technology, which uses GMP-grade CO2 recycled from local industrial side streams as a solvent. The process produces excipient-free, dry API nanoparticles directly from solution with significantly increased bioavailability – achieving the desired effect without contributing to the environmental harm caused by organic solvents.
Supply chain carbon-cutting
The transportation of drug products from manufacturing facilities into patients’ hands is another area where sustainability can be improved in the pharma industry. These products are often distributed around the world, being shipped by air or sea across vast distances. In fact, it is estimated that the healthcare sector contributes approximately 5% of global greenhouse gas emissions, with around half of this footprint residing in healthcare supply chains. In response, an Open Letter has been signed by the CEOs of major pharma companies, such as AstraZeneca, GSK, Merck, Novo Nordisk, Sanofi, Samsung Biologics and the Chairman of Roche, outlining targets to reduce emissions across the value chain.
By enhancing the bioavailability of drugs, and hence lowering the required dosage and amount being shipped, the environmental impact incurred by transport per unit of drug manufactured can potentially be reduced. This can have far-reaching impacts going backward through the supply chain, lowering the volume of raw materials within initial API manufacturing. It may also provide API manufacturers with the opportunity to bring operations closer to home, enabling a more agile and secure supply chain.
By reducing API particle size down to a uniquely small nano-size range, Nanoform can play a part in this, enabling the development of smaller drug products, less packaging and reduced logistical burdens.
Aligning with patient and planet needs
Even after the medicines have been delivered to patients, pharmaceutical companies can still influence sustainability. The use of nanoparticle engineering techniques during development has the potential to positively impact compliance and discarded waste.
The U.S. alone produces over 3.5 million tons of medical waste annually. Further studies show that 11% of households have residual waste medicines, with 8% of medicine packs being partially or completely unused. For chronic illnesses, estimates for non-adherence stand as high as 50%, which means poorer therapeutic outcomes for patients.
A common reason for this lack of adherence is drug administration routes not aligning with patient preferences. Studies show, for example, that one in six U.S. adults experience difficulties swallowing. Unwanted side effects and complex drug regimens also contribute to non-compliance in patients.
By formulating for alternative, more patient-centric delivery routes such as oral, inhaled and ophthalmic, manufacturers can help patients access more convenient forms of drug delivery to improve patient compliance and, therefore, sustainability. Local drug delivery routes can also boost compliance by reducing adverse side effects originating from systemic circulation, with drugs being administered directly to the site of action instead.
By utilising nanoparticle engineering techniques to generate API nanoparticles that are small enough to cross biological membranes that traditionally pose a challenge, new, more patient-friendly delivery routes can be opened up to further improve therapeutic outcomes.
AI-driven approaches to improve sustainability
In addition to technological advances that can increase bioavailability and enhance drug delivery for improved efficacy, lower manufacturing footprint and increased compliance, advances in AI also promise to help the pharma industry become greener. Growth in the AI sector is driving confidence in AI-driven experimental approaches. From identifying target proteins to virtual screening, AI-guided approaches to data handling are becoming more widely adopted across the drug development pipeline, revolutionising what was thought possible.
Pharma companies are beginning to see the benefits of these novel tools, with a spate of AI-designed drug candidates now entering clinical trials and potentially driving positive patient outcomes in the near future. Additionally, at the R&D stage of the drug discovery journey, pharmaceutical companies normally test a number of drug design pathways in the lab to identify potential candidates. This can be both time-consuming and wasteful for labs. By taking advantage of technologies to inform decision-making, such as AI and digital twinning, pharmaceutical companies can undertake in silico experiments to pre-emptively rule out drug design pathways that would not have proven viable.
AI can also be used to help enhance drug properties and overcome formulation challenges during development. For example, AI can be used alongside nanoparticle engineering to predict success, ultimately de-risking innovative new approaches for businesses and reducing experimental waste associated with failed development.
Selecting a drug development partner
From R&D to manufacturing and patient use, there are opportunities across the full pharmaceutical value chain to be more environmentally-friendly. In order to achieve this, it is vital to partner with companies that share the same values and who can work reactively to solve specific challenges without compromising on sustainability.
Moving forward, collaboration between technology innovators and pharma companies will be key to both overcoming drug development challenges and simultaneously improving sustainability in the industry. The end result will be sustainably produced life-changing medicines that can improve the lives of patients worldwide, without harming the planet.