Achieving Sustainability and Efficiency in Pharmaceutical Production
Joel Eichmann, Co-Founder and Managing Director, Green Elephant Biotech.
Undeniably, the biopharmaceutical industry significantly contributes to climate change. The life science sector, as a whole, emits a staggering 55% more greenhouse gases than the automotive manufacturing sector. Laboratories engaged in biological, medical and agricultural research are culpable for generating an annual 5.5 million tons of plastic waste, representing 2% of the global plastic waste burden. And that does not include manufacturing or diagnostics.
In terms of sustainability, it seems the industry is moving in the wrong direction. Projections indicate a 15.9% growth in the pharmaceutical manufacturing market between 2022 and 2030, threatening to amplify the industry's climate impact - unless action is taken. Alarmingly, a report on the industry's carbon impact reveals that 91% of surveyed public biotech and pharmaceutical companies have not yet committed to measures aligned with the crucial 1.5-degree climate target.
The absurdity, of course, is that the climate crisis is exacerbating public health challenges. The detrimental impact of greenhouse gas emissions on health is evident, with the combined effects of ambient and household air pollution leading to a staggering 6.7 million premature deaths annually from conditions like stroke, lung cancer and heart or lung diseases. And that doesn't even take into account other impacts related to rising temperatures and extreme weather conditions.
So how can the biopharma industry ensure it is not part of the problem while developing therapeutic solutions?
Sustainability and increased efficiency go hand-in-hand
In a fast-growing sector where capacity is struggling to keep up with demand, and new products keep challenging the manufacturing paradigm, sustainability can seem like a "nice-to-have." Even efficiency is often stalled for consideration as part of late-stage process improvements -- or outsourced entirely. But has become urgent to prioritise them from the earliest stages of development, and to couple increased efficiency simultaneously with sustainability. Addressing each separately in a vacuum tends can lead to incremental change and window dressing as policy.
A great example of the challenge and potential is the cell and gene therapy (CGT) sector. Here, production breaks with traditional biopharma models, requiring the management of many personalised, small batches in a field where scaling up has always been about product homogenisation. It is possible to identify process adjustments that can both increase efficiency and have a positive effect on sustainability, instead of just treating them as further hurdles.
This work is happening today: companies are implementing closed systems that reduce the risk of contamination while allowing operation in low clean room levels. This significantly reduces both energy consumption and gowning waste, often accelerating the manufacturing process. Additionally, increased automation has begun to improve production efficiency while reducing resources wasted due to errors or inefficient practices. Further, digitalisation not only helps improve processes but also has the potential to provide insights into how to further use means of production more efficiently.
Drilling down: the CellScrew
Broad-concept approaches like automation and digitalisation are just one piece of the puzzle. Specific products and services can also directly impact both sustainability and efficiency. One case study is the CellScrew, a novel cell culture system designed for adherent cells like HEK-293 cells, widely used in research. It is also ideal for culturing induced pluripotent stem cells (iPSCs), which are highly valued In the CGT space for their ability to differentiate into various types of cells with value as therapeutics, including CD38+ cells like the new gene therapies for sickle cell disease, pancreatic islet cells like the new cell therapy for Type 1 diabetes, and experimental technologies such as cytotoxic T lymphocytes, NK cells or dendritic cells.
We have developed the CellScrew using plant-based polylactic acid (PLA), a renewable, plant-based polymer derived from corn starch. Its synthesis involves fermenting glucose from organic plants, and subsequent purification processes post-lactic acid extraction ensure consistent quality and limited variability across PLA production batches.
PLA has proven to be a practical, environmentally friendly substitute for conventional plastics, and has been demonstrated non-toxic and biocompatible through extensively testing. This makes it key for sustainable and efficient labs, and today it is commonly employed in medical technology, such as in the production of implants or prostheses.
Plant-based plastics have obvious benefits over traditional plastics for environmental sustainability, but the CellScrew also shows it is possible to leverage some unique properties of PLA to design laboratory equipment for increased production capacity through greater efficiency. The PLA surface can be tissue culture-treated to optimise its material properties for cell growth and adhesion, making it ideal for cell cultivation vessels and a number of other laboratory products. The CellScrew also exploits PLA's favourable thermal processing and mechanical properties (which are comparable to polystyrene).
The CellScrew is designed with a distinctive internal structure that is manufactured in a 3D printer that reduces the material required and helps lowers its carbon footprint by 90% compared to polystyrene-based vessels. Its unique architecture, featuring an Archimedes' screw and concentric cylinders, not only forms a substantial growth surface but also fosters optimal conditions for adherent cells. Such an expansive growth surface can help streamline processes and elevate production capacities – efficiencies of particular value in contexts where skilled personnel are scarce, such as CGT manufacturing. The design facilitates effective mixing of the medium and ensures thorough gas exchange, all achieved with low shear force.
Designing a sustainable future
At Green Elephant Biotech, we are taking this concept another step forward and are developing an advanced, fully automated and closed cell cultivation system, the Archimedes platform. This system is designed to seamlessly incorporate the CellScrew, offering comprehensive monitoring and control of essential cell cultivation parameters like oxygen, pH, glucose and lactate. The Archimedes platform will significantly reduce the amount of manual labour associated with adherent cell manufacturing, as steps like seeding, media changes and cell harvesting are automated. Altogether, the CellScrew and the Archimedes platform are designed to enable the efficient and sustainable industrialisation of cell and gene therapies.
Sustainability shouldn't be considered as an extra burden in pharmaceutical production; when prioritised appropriately, it instead surfaces as a strategic instrument for optimising efficiency and cost effectiveness. By its nature, biotechnology is rapidly producing many technical innovations, and the CGT space is emblematic of these advances. If manufacturers take aspects of sustainability and efficiency into account when implementing new solutions, they can not only gain a competitive advantage but also be better prepared as regulatory standards for sustainability evolve.