How can we make biomanufacturing for life sciences and healthcare more sustainable?

When a team of Canadian researchers discovered how to isolate, extract, purify and administer insulin in the 1920s, they transformed the treatment of diabetes. Their use of this naturally occurring hormone to create medicine also kick-started the development of biomanufacturing in life sciences and healthcare.

Skip forward a century and biologics – biomanufactured drugs made from natural resources like microorganisms and cells – offer a vast range of personalized and targeted treatments. This is the sector that, in 2020, collaborated to develop, produce and distribute effective vaccines to combat COVID-19 in a matter of months – a process that would normally take years.

Today, biomanufacturers are innovating at pace, and growing their production, supply and distribution capacity so they can meet unmet medical needs and an increasing demand from an aging global population. But, currently Life Sciences and Healthcare therapy development and production activities generate 4.4% of global emissions, this means these companies cannot continue on this path – they must produce more with less resources.

Pressure on sustainability performance is coming from all sides. Measures that were once secondary concerns – like reducing waste, energy consumption and emissions – are now a top priority for business leaders. Companies face intense scrutiny from investors and customers when it comes to advancing sustainability in biomanufacturing while reducing costs. And they must also prove their performance against increasingly stringent regulations.

A closer look at biologics

Biologics excel in targeting the proteins, cells or pathways involved in a disease’s progression. Examples include monoclonal antibodies, which are designed to neutralize harmful proteins in the body. Then there are cytokines, which modify immune system responses to fight off or suppress a specific condition. Meanwhile vaccines prevent diseases from developing by stimulating the immune system to fight certain pathogens.

This targeting ability makes biologics effective for treating chronic diseases including autoimmune disorders, cancer, diabetes, inflammatory bowel disease and rheumatoid arthritis. They are also less likely to cause side effects than conventional drugs, which act more broadly across the body.

However, the size and complexity of the molecules involved means that biologics are more complex, time-consuming and costly to manufacture than conventional drugs, which are made from smaller, simpler molecules. The procedure typically begins when a gene, which encodes the desired protein, is transferred into “production cells” such as E. coli bacteria. These cells are then cultivated in a bioreactor under carefully controlled conditions such as temperature, pH and nutrient supply. When the cells are ready, they are processed to release the protein. This is then refined to make sure it meets the purity, potency and safety standards required.

These processes use significant natural resources and energy while producing emissions and waste. But biomanufacturers need to be sure that any measures they take to improve sustainability will not adversely affect the quality of their product, but must be also cognizant of the waste they create. To minimize that risk, sustainability must be designed into these delicate procedures, not bolted afterwards.

Where can biomanufacturers make sustainability gains?

To make meaningful sustainability gains, biomanufacturers must adopt a new paradigm and factor in sustainability concerns from the very beginning of drug development.  From the ideation of the drug to the biologic process to facility development on through delivery, each stage in the development process can include sustainability indicators that impact the whole.

Let’s look at a few:

• Product development. On average, 80% of any product’s environmental impact is made during the design phase. If biologic developers identify which manufacturing methods will yield the best results for their recipe and the environment, they can make a big dent in that figure.
• Supply chain and logistics. These activities typically account for 60-80% of a pharmaceutical company’s greenhouse gas emissions. Those percentages come down when key performance indicators (KPIs) for sustainability are factored into supply chain design from the start.
• Continual process improvement. By monitoring environmental performance alongside critical parameters – such as temperature, which is crucial in biologic production – it’s possible to identify small changes that will improve on the process  without risking the product’s quality.

What challenges are slowing progress toward sustainability in biomanufacturing?

Knowing where to look is one thing. Finding the information can be quite another, especially since pharmaceutical companies tend to have volumes of scientific data across separate systems and departments. This disjointed view makes it difficult to build a common sustainability strategy across the organization or the product lifecycle. As a result, measures often focus on individual business units, which limits their success.

Factoring in third-party providers such as suppliers and logistics organizations throws up more obstacles. When decision-makers don’t have all the information available in one place, they can’t make informed decisions that balance sustainability alongside KPIs like time and cost.

And what about those opportunities for improvement that emerge during manufacturing? Without a holistic view, based on all the data involved, it’s impossible to know where to look, or what effect any decisions will have further down the line.

Digitalization can drive sustainability in biomanufacturing

Unifying data in one place – the 3DEXPERIENCE platform – has helped Dassault Systèmes customers across Life Sciences & Healthcare and other industries to put sustainability performance in the context of other critical KPIs. The platform allows the creation of virtual twins – holistic digital models of real-world products, systems and processes. By using a virtual twin to structure and contextualize data it allows to see how different KPIs relate to each other across the product lifecycle, biomanufacturers can target new measures wherever they are needed,

It’s important for biomanufacturers to target areas where the biggest sustainability gains can be achieved. They can use a recipe lifecycle management solution, for instance, to see how different processes all along the product lifecycle – such as an energy-intensive or high-emission manufacturing method or some aspects of the supply chain– will affect a product’s environmental impact. Then they can make the appropriate changes to bring those figures down.

Solutions are also available to support the optimization of supply and demand planning. For example, a built-in algorithm can be used to show supply chain planners which suppliers perform best across KPIs like sustainability, reliability and cost, so they can choose the one that strikes the best balance between all those priorities.

Once the biologic enters production, monitoring processes and equipment in real time is essential to identify ongoing opportunities for improvement. This is what the  Continued Process Verification toolset does. Its algorithm helps companies understand the different patterns at play in areas like energy consumption and emissions, as well as production parameters – so users can see where to make changes that will improve sustainability while staying within production parameters.

Sustaining the journey

There has always been a sound business incentive for improving sustainability. Minimizing waste and reducing energy consumption often go hand in hand with increased efficiency, as well as potentially attracting more customers and investors. What’s been missing until recently is the joined-up view that shows how and where sustainability can be optimized in balance with performance and quality KPIs across the product lifecycle.

Technologies like those discussed above are bringing that view to life, supported by powerful algorithms. We’re just starting to see how artificial intelligence, with its complex data analysis capabilities, can play a pivotal role in enabling biomanufacturers to thread sustainability across their business. In this intensely innovative industry, it will be exciting to see how companies work to achieve that.

Check out our new whitepaper, “Innovating for a More Sustinable Future: Leveraging Greener Practices in Biomanufacturing” for an even deeper dive into sustainability in biomanufacturing, including how advanced  digital tools like AI and virtual twins allow companies to improve efficiency and reduce emissions, waste, energy, and water usage while ensuring quality and safety.