In a recent LinkedIn article, I shared my vision for our industry – about how my vision is to extend the healthy life expectancy for all with sustainable healthcare systems … but this comes with its challenges and the key word here is ‘sustainable’!
When we talk about sustainability in the Life Sciences & Healthcare industry, I believe we need to take a 3 pronged approach.
- First, science sustaining Society – This is all about enabling science driven companies to create affordable accessible therapies for all. The means not only developing and manufacturing precision therapies in a sustainable, affordable manner but also ensuring that these therapies and healthcare as a whole is available to those who need it when they need it. The potential of changing access to healthcare is easily imaginable now that we are all accustomed to our new online world.
- Second, sustaining the Environment – This is all about how our industry is reacting to the sustainability mandate and reducing its carbon footprint and sustaining nature. In a recent study by The Kingsfund, they found that carbon dioxide emissions attributable to the NHS in England alone are greater than the total admissions from all passenger aircraft departing from Heathrow Airport. The production of pharmaceuticals and medical devices constitutes the biggest contributors. This shows just how important it is for our industry to actively engage in sustainability efforts to reduce the carbon emissions across the entire value chain.
- The third and final area is all about Life Sciences companies being able to sustain their business by confidently demonstrating global manufacturing compliance and integrity in a transparent & cost effective way thus engendering trust from regulators and patients and sustainable revenue generation. COVID has thrust a spotlight from governing bodies and regulators on our industry – now is the time for life sciences companies to leverage best-in-class scientific tools to revolutionize their business and deliver innovative therapies while ensuring environmental, social and business sustainability.
Today I want to focus on one specific area… biomanufacturing. According to a report by Accenture and Dassault Systèmes, analyses of emissions per million dollars of revenue find that the global pharmaceutical industry is approximately 55 percent more emissions-intensive than the automotive industry and the pharmaceutical industry’s greenhouse gas (GHG) emissions are increasing despite efforts to decarbonize. In addition, 28% of the pharmaceutical sector (by market share) has joined the United Nations’ Race to Zero commitment to reach net-zero emissions by 2050 (Source).
So, how can this be achieved?
As populations globally continue to grow, demographics continue to shift as people live longer and in affluence. The World Health Organization (WHO) indeed estimates that nearly 2 billion people across the world are expected to be over 60 years old by 2050, a figure that is more than triple what it was in 2000. This explains why the number of cancer and neurodegenerative diseases is expected to keep growing. In addition, choices made by individuals in their lifestyle affect their health status. For example, increasing urbanization drives air pollution and can cause respiratory diseases and habits in terms of diet, sport, etc. can be the source of chronic diseases such as diabetes or cardiovascular diseases. Overall, according to the US Centers for Disease Control and Prevention, chronic diseases account for 86% of annual healthcare spending.
All these chronic diseases share one common characteristic: they are complex multifactorial diseases, hence not easy to treat or cure.
The pharmaceutical and biotech industry has adapted to this challenge by developing sophisticated therapies, which differ from traditional pharmaceutical products that tended to be based on small molecules and were formulated as tablets or similar oral dosage forms. The novel therapies against complex diseases, such as cancer, are often based on biological therapeutic ingredients (monoclonal antibodies or antibody fragments, recombinant proteins, cell & gene therapies…), which are administered through sophisticated injectors (which can deliver the treatment at home) or even infusions. So, not only is there increasing complexity in the drug product itself, but also in the packaging and device requirements to deliver that drug…
Additionally the new therapies described above require cold chain logistics – as biological substances they are prone to deteriorate in ‘normal’ conditions. We have heard this in connection to the first mRNA vaccines to come to market (Pfizer/BioNTech, Moderna). This means that not only has the drug and the packaging/device requirements become more complex, the global distribution of such therapies has also become more of a challenge.
With the rising complexity of therapies, complex and resource intensive processes, affordability and accessibility demands for new products, then it becomes evident that pharmaceutical manufacturing has to change the way it is done today. From paper-based, non-standardized processes that are not well enough understood, we have to move to a way that allows us to standardize individual process steps, to understand the process – ideally using modelling & simulation and the ability to optimize such processes.
The solution? The Virtual Twin. Virtual twins allow organizations to model, simulate and optimize the system under consideration: at the plant level, at the process level, at the production line level and at the equipment level. It provides a way to capture all knowledge around behavior and features of those systems by facilitating continuous improvements of processes and simultaneously facilitating regulatory readiness through knowledge management.
To build impactful virtual twins a solid scientific foundation is required. Indeed, you need to understand the product characteristics at multiple scales, from the molecular level to higher scales. Let me take 2 examples:
- At the molecular level: the 3D shape of the protein dictates its function and can be impacted by many parameters – you want to get them right if you want to guarantee the product efficacy
- When you simulate speed of syringe filling, on a F&F line, you want to make sure you accurately predict the production of air bubbles, as they will impact product quality.
So, science is key.
But, let me add another dimension: Collaboration. Indeed these virtual twins for biomanufacturing require a multiscale approach, but also a multidisciplinary one. If you want several disciplines to collectively model & simulate twins of the manufacturing line, then collaboration is required to support data and information sharing and permit creative ways of engaging with that data to truly accelerate the time-to-market and to avoid any duplication and wasted efforts.
We have witnessed this during the race to deliver COVID vaccines globally. Pharmaceutical companies are moving from relatively rigid and difficult-to-change supply chains to dynamic supply networks consisting of a range of contract manufacturers, engineering services providers, Biotech companies and clinical research organizations.
Using a scientific platform hosted virtual twin, collaborators can design and engineer the complex processes and operations that involve many stakeholders and actors and thus enable pharmaceutical companies to have more sustainable manufacturing operations delivered by all partners in the network efficiently and without any delay.
The use of virtual twins for complex systems such as modern pharmaceutical manufacturing processes ultimately are, are endless and I am unable here to go into each of the applications but you can find out more here or get in touch with us to find out how virtual twins can transform your biopharma manufacturing organization.