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In recent years, the field of cell and gene therapy (CGT) has garnered significant attention for its groundbreaking potential to treat previously untreatable diseases. This excitement, however, is offset by growing awareness of the environmental footprint of these advanced medical treatments.
With the health care sector responsible for approximately 5 per cent of global greenhouse gas emissions, addressing the environmental implications of biopharmaceutical manufacturing, particularly CGT, is more crucial than ever. Despite this urgency, comprehensive environmental sustainability assessments have been conducted for only around 0.2 per cent of pharmaceuticals, highlighting an alarming gap in our understanding of the industry’s broader environmental impacts.
Life cycle assessment
Life Cycle Assessment (LCA) has emerged as the standard methodology for evaluating the environmental impact of products and services, including pharmaceuticals, across their entire life cycle – from raw material extraction through production, usage and disposal.
This scientific tool systematically quantifies impacts across multiple categories, such as climate change, resource depletion, toxicity and human health effects. By identifying environmental hotspots and trade-offs, LCA enables stakeholders to take targeted, informed actions to mitigate detrimental impacts and facilitate sustainable innovation. For example, LCA shows that energy consumption and chemical usage are major contributors to the environmental impact within the pharmaceutical sector.
The distinctive advantage of LCA lies in its comprehensive, process-oriented approach, setting it apart from other environmental assessment methods like risk assessment or material flow analysis. However, implementing LCA in the biopharmaceutical sector is not without challenges. Defining appropriate system boundaries – whether cradle-to-grave, cradle-to-gate, or gate-to-gate – is critical to capturing the full scope of environmental impacts. Likewise, the decision between attributional LCA (ALCA), which assesses existing systems, and consequential LCA (CLCA), which predicts future impacts based on marginal changes, depends heavily on available data and specific objectives.
Currently, the biopharmaceutical industry suffers from inadequate life cycle inventory (LCI) data, forcing reliance on analogous data from related sectors, thus complicating accurate assessments. Overcoming these challenges through enhanced data collection and methodological rigour is essential for robust sustainability evaluations.
Traditional facilities vs. single-use technologies
Traditionally, biopharmaceutical manufacturing facilities have relied heavily on multi-use equipment, predominantly stainless steel, which requires extensive cleaning and sterilization between production batches. These traditional facilities, although well-established, carry significant environmental burdens such as high water use, energy-intensive sterilization and substantial chemical usage. Hence, traditional processes typically generate large amounts of waste and require substantial physical infrastructure and operational maintenance.
In response to these sustainability concerns, single-use technologies (SUTs) have rapidly gained traction over the past 15 years. SUTs utilize disposable components that eliminate the need for cleaning between batches, significantly reducing water, energy and chemical usage. Surprisingly, comprehensive LCA studies reveal that despite generating more plastic waste at end-of-life, SUTs usually result in lower overall environmental impacts compared to traditional reusable systems. This reduction stems from the dramatic decrease in energy and resource-intensive sterilization processes, ultimately translating into reduced carbon emissions, water consumption and chemical use.
Several landmark studies substantiate these claims. Sinclair and Monge highlighted that SUTs significantly reduce water use, physical space and energy consumption compared to traditional multi-use facilities due to the eliminated cleaning and sterilization steps. These findings underscore a critical realization: end-of-life plastic waste, though visibly concerning, constitutes only a minor fraction of the total lifecycle environmental impact.
Another recent comparative LCA analysis demonstrates that SUTs can drive substantial cost and efficiency gains through process intensification. For example, optimizing cell culture density or improving production yields becomes more feasible with SUTs, directly benefiting both sustainability and economic viability. These systems also offer significant operational flexibility, facilitating scalability from bench-top experimentation to full-scale bioreactor production, minimizing unnecessary resource use and waste generation.
Despite these clear advantages, the environmental performance of SUTs can vary significantly based on geographic and logistical factors. The composition of regional energy grids and proximity to recycling or waste management infrastructure critically influence the overall sustainability of SUTs. For example, SUTs deployed in regions reliant on fossil fuels for electricity or those lacking adequate recycling facilities may encounter amplified environmental impacts, highlighting the importance of contextual considerations in sustainability evaluations.
Future pathways
As CGT continues its rapid market growth, anticipated to accelerate further due to multiple ongoing clinical trials and upcoming regulatory approvals, the necessity for integrated sustainability solutions becomes increasingly apparent. Innovations like Krakatoa™, a pioneering point-of-use cell culture media production system using biodegradable pods, exemplify the sector’s potential for groundbreaking environmental progress. Krakatoa significantly reduces greenhouse gas emissions, transportation impacts and waste generation while ensuring optimal media potency and stability.
The transformative promise of CGTs must be matched by equally innovative approaches to minimize their environmental impact. As the biopharmaceutical sector expands, particularly in the CGT space, sustainability can no longer remain an afterthought.
LCA has proven to be a vital tool in identifying environmental hotspots and informing strategic interventions across manufacturing processes. The shift from traditional stainless-steel facilities to SUTs illustrates how design innovations can drive substantial environmental and operational benefits, though with context-dependent trade-offs.
Addressing sustainability in biomanufacturing is not a one-size-fits-all solution. It requires tailored strategies, informed by robust data, advanced analytics and localized infrastructure capabilities. Future progress hinges on greater transparency, standardized data collection, and ongoing collaboration between industry stakeholders, researchers and policymakers. By embracing circular design principles, investing in low-impact innovations and embedding sustainability into the early stages of process development, the biopharmaceutical industry can chart a path toward producing life-saving therapies without compromising planetary health. The opportunity lies not only in healing human disease but in redefining how we manufacture medicine – with responsibility, resilience and respect for the environment.
Laya Kiani
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