A More Sustainable Future for Pharma is Possible

COP26 was delayed by a year because of the pandemic but starting Sunday, 31 October more than 120 world leaders are gathering at the Glasgow conference to accelerate the global response to climate change. It’s a huge task, with highly complex negotiations and ambitious goals. While the outcome of the conference remains to be seen, it has already helped raise awareness of what’s at stake and prompted individuals and companies alike to take more responsibility for the impact their actions may have on the environment. 

It’s encouraging that sustainability commitments are common throughout the pharmaceutical industry. Although pharma companies don’t immediately come to mind when considering major industrial impacts such as coal consumption or threats to biodiversity, it’s inevitable that the production, distribution, and administration of nearly 7 billion COVID-19 vaccine doses globally will have increased carbon dioxide emissions. It seems almost petty to talk about environmental impact when the public health benefits of vaccines are so significant yet carbon dioxide emissions from healthcare provision account for about 5% of national carbon footprints in the world’s largest economies.  

Looking after the health and well-being of patients is clearly top priority for the pharmaceutical and healthcare industries, but thankfully there are steps that can be taken to reduce environmental impact without compromising patient safety. Single-use (plastic) components are a prime example: the benefits of sterile, ready-to-use materials are obvious when it comes to preventing contamination but perhaps counterintuitively, single-use technologies for biopharma development and manufacturing also usually have a better overall ecological footprint than comparable reusable systems. This is mainly because less water and energy are needed compared to the extensive cleaning and sterilization required for multiuse (stainless steel) technologies.  

Single-use components in biopharma research and manufacturing currently account for only 0.01% of the annual volume of plastics waste but this is steadily increasing. Which brings another set of challenges: these products tend to be complex, multilayer plastics which limits recycling options. Suppliers, biopharma manufacturers, and industry consortia such as the Bio-Process Systems Alliance have all been actively working on this challenge and identifying creative ways to transform used materials into new products such as construction materials. 

There are even simpler ways to reduce the environmental impact of biopharma R&D and manufacturing with both short-term and long-term benefits: improve inventory management and increase the efficiency and effectiveness of process development.  

For many biopharma companies, a reliance on largely paper-based or siloed data sources in R&D means it’s difficult to manage lab inventory effectively. It’s not unheard of for biopharma companies to buy additional freezers for process development samples because they don’t know which samples are likely to be needed later and don’t want to risk throwing anything away. In an even more dramatic example, one pharma company saved enough lab space by painstakingly sorting through and managing their lab inventory to avoid having to invest in a new facility to expand their operations. 

The same issues and inefficiencies affect all aspects of process development. With the launch of IDBS Polar, IDBS now provides a first-of-its-kind “data backbone” for the biopharmaceutical industry. Polar is designed to reduce operational inefficiencies by up to 40% and avoid the 10% re-work that is typically attributable to poor data access. The data backbone Polar provides is essential to enable teams to share knowledge and gain insight from collective experience. 

There’s increasing interest in intensified bioprocessing methods such as continuous and integrated operations which can be run in smaller facilities with reduced energy consumption and reduced plastics use. Although fully continuous processing techniques offer both economic and environmental advantages, there are still perceived quality management challenges such as how to achieve real-time monitoring and how to define a batch or lot. What’s needed to support the adoption of these technologies in commercial manufacturing is data – and not just any data, data that gives confidence that the process development work to define a robust manufacturing process was truly representative of what’s likely to occur on the plant floor. 

And this is the real power that a properly curated, highly contextualized data backbone can provide: the ability to optimize processes on multiple dimensions. Currently, the primary focus of process optimization is improving product yield and quality. This is difficult enough to achieve when much of the data is held in inaccessible data silos, let alone trying to consider other dimensions such as environmental impact. There is no shortage of process modelling tools to simulate manufacturing performance and predict water/energy requirements and waste generation, but the output of these modelling activities is only as good as the data they’re based on. 

With better access to quality data, therefore, process modelling and tools such as life-cycle assessment (LCA) can be used much more effectively to both understand and minimize the environmental impact of biomanufacturing. The earlier in the development process the environmental impact of design choices is understood, the better – which is where advanced modelling and analytics such as digital twins that can predict large-scale performance based on small-scale data offer the potential to significantly improve the sustainability of biopharma operations. There’s still a lot of work to be done, but the right foundation makes the job much easier. 

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