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Robert Newman is Chief Scientific Officer at FUJIFILM Irvine Scientific and Tom Fletcher is Director of Research and Development at FUJIFILM Irvine Scientific.
While the global demand for new sustainability measures continues to be a focus, it is important to identify ways to reduce risks associated with handling, managing raw materials and maximising the impact of limited resources by improving efficiency with simplified cell culture media and buffer preparation methods and resource allocations that optimise productivity. An efficient, sustainable bioprocessing workflow is crucial for the timely production of biologics and therapies to both the manufacturer and patients.
The bioprocessing industry plays a pivotal role in the life sciences sector by providing cells, culture media and other essential materials necessary for the rapid advancement of innovations such as cell and gene-based therapies and biologics. As the demand for advanced therapeutics continues to grow, so does the need for optimised bioproduction workflows that ensure consistent, large-scale, and cost-effective manufacturing. Coupled with the requirements for dramatically expanded outputs, the industry has seen mounting pressure to establish environmentally sustainable processes, with some pushing to move away from ‘single-use’ technologies – but is the solution as clear cut as it seems?
Reflecting on the trajectory of the industry thus far, it becomes important to examine the latest trends and successes, and the key workflow challenges that remain within the bioprocessing sector. The demands and risks associated with handling and processing raw materials are multi-faceted, particularly when considering how to maximise resources, simplify and optimise media and buffer preparation. These next-generation solutions must be developed to address pressing concerns related to environmental impact, which in themselves are complex.
Moving Towards Sustainable Manufacturing Workflows
In line with the advances of the bioprocessing industry, the optimisation and evolution of high performance cell culture media formulas and their manufacturing is key. Use of custom optimised culture media formulas can elevate process efficiency, to achieve higher titers, consistency, and improved product quality, leading to a significant reduction in waste – all components essential to the overall push to more sustainable manufacturing practice.
One pivotal advancement in increasing process efficiency is the move towards using chemically- defined cell culture media, which has enabled researchers’ full control over their media formulas. Removing all undefined or animal-derived components ensures the consistency of culture media formulas, with minimal risk of impurities from biological and variable materials, enabling therapeutic developers to effectively operate within strict regulatory landscapes and adhere to necessary safety requirements. Chemically-defined culture media not only enhance process control but also establish a foundation for reliable and sustainable manufacturing practices.
When seeking to address sustainability in any industry, effective and responsible waste management is key; not only minimising it, but also appropriate disposal. In bioprocessing workflows, these by-products could be solid waste from consumables (packaging), or liquid produced by the process itself or via system cleaning. Process optimisation provides a primary strategy to minimise this waste. However, as the stages of bioproduction demand careful and individualised fine-tuning, this is not a simple solution. Balancing waste reduction efforts with the intricacies of complex bioprocessing stages underscores the need for comprehensive waste management strategies.
The integration of increasingly sophisticated and intricate technologies, in combination with the development of process analytical technologies (PATs) and the artificial intelligence (AI) revolution has resulted in a surge of advanced automation technologies to optimise bioprocessing workflows. Harnessing AI, these systems enable critical parameters to be monitored during continuous manufacturing. This real-time data analysis facilitates ongoing process optimisation that would not be possible using traditional manual techniques. In addition, automated manufacturing minimises the possibility of human error, a risk that can significantly impact workflow efficiency or, in the worst case, cause a batch to fail entirely. By introducing automation, laboratories can ensure batch-to-batch consistency, accelerate and streamline processes, to maximise resources and reduce waste output. Furthermore, sustainable management technologies, such as membrane bioreactors for wastewater purification can be integrated to address waste that cannot be eliminated in culture media preparation workflows.
Single-Use Technologies
Contamination poses significant challenges in the development of biologics and therapies, not only risking human health, but also efficiency and cost of manufacture. Once detected, contaminated batches, and any other materials at risk, are disposed of - depending on how far into the process this occurs, it could result in a large amount of wasted raw material, energy, and time, significantly impacting a biopharmaceutical manufacturer’s output and carbon footprint. As such, efforts to eliminate risk of contamination are essential to manufacturers.
The adoption of single-use technologies (SUTs) has become an integral part of modern bioprocessing, both across manual and automated workflows. Often composed of disposable plastic, these consumables eliminate the risk of cross-contamination, as opposed to conventional, reusable stainless steel or glass systems which require extensive cleaning and sterilisation between culture media preparation workflows. Not only does the cleaning process use additional resources, time and manual labour in comparison to SUTs, it drives up energy and water use. Despite these efforts, contamination may still occur. Latest advances in automated media and buffer preparation systems harness SUTs with pre-packaged media cartridges, eliminating the need for bag installation and constant monitoring, to further maximise efficiency and reproducibility.
Addressing the challenge of disposable plastics is imperative when integrating them into sustainable workflows. Globally, there is increasing pressure on governments to impose stricter regulations on recycling and single-use materials, particularly around new plastic production, in an effort to minimise landfill and avoid toxicities when the materials break down into microplastics, which pose threat to all ecosystems. In the United States alone, an estimated 40 million tons of municipal plastic waste were generated in 2021, with at least 85% sent to landfill sites, of this, an estimated 30,000 tons of biopharma single-use products. Recycling such specialised plastics can be more complicated than standard waste, often containing different polymers, multi-layer films and potentially hazardous materials, which must be sterilised and appropriately disposed of.
The indispensability of plastics is recognised universally in the medical sector, owing to their high versatility and ability to be sterilised, and therefore raises the question: in what instances is single-use plastic appropriate? And when the benefits are substantial, how can we mitigate the impacts of new production? Consequently, efforts are being made within the industry to demonstrate these materials are not predestined for landfill. With SUTs, there are two main routes for recycling – energy production and material production. For example, the Biopharma Recycling Program, launched in 2015, where scrap materials are recycled into various grades of plastic lumber, used in landscaping, speed bumps and garden furniture, and many other applications (3). And in 2018, Novo Nordisk announced that 94% of its manufacturing waste materials were recycled, harnessing waste materials for local energy production infrastructure.
Looking Forward
The discussion surrounding sustainability in the biopharmaceutical industry is extensive, demanding careful considerations between maximising workflow efficiency to advance innovation and mitigating environmental impacts. Realistically, this balance is also paired with perspectives in relation to local and corporate priorities, including the societal shift in environmental-consciousness and the growing expectations of customers towards manufacturers.
When assessing the impact of SUTs, reducing cost of workflows, and sustainability, key industry leaders are increasingly recognising that environmental considerations are interwoven: if natural resources are not protected, supply of raw materials cannot be secured. Consequently, more attention should be given to responsible operations and assessing overall carbon footprint and water usage, such as, the potential energy savings achievable with SUTs, to offset the added impact of plastic. By prioritising social responsibility, many companies have outlined ongoing sustainability initiatives, for example, FUJIFILM Irvine Scientific’s new purpose-built facility in Tilburg, Netherlands, that prioritises specific strategies that adhere to the Fujifilm Sustainability Value Plan 2030 for sustainable growth (5).
Demand is driven by customers, but as the bioprocessing industry continues to expand, collaborative solutions are required at all points in the supply chain to address current and future issues in SUT and the industry’s environmental impact as a whole. The implications of pharmaceutical waste entering the environment must also be effectively communicated to patients; the largest contributions being from patient use and the improper disposal of drugs. The third is from pharmaceutical waste from manufacturing facilities. An efficient, sustainable bioprocessing workflow is crucial for the timely production of biologics and therapies to both the manufacturer and patients, for years to come.